Back to resultsWeight Loss in Adults With Obesity Using a Combination of Low Energy Diet, Group Treatment and Intragastric Balloon
Primary Purpose
Obesity, Weight Loss, Non-Alcoholic Fatty Liver Disease
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Low energy diet using meal replacements
CBT-based group treatment
Intragastric balloon
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight loss, Low energy diet, Intragastric balloon, Group treatment, Non-alcoholic fatty liver disease, Quality of life, Body weight, Glucose metabolism, Eating behavior, Microbiomics, Physical activity, Gastrointestinal symptoms, Psychological parameters
Eligibility Criteria
Inclusion Criteria:
- BMI ≥ 30 and ≤45 kg/m^2
- Age 30 to 65 years
Exclusion Criteria:
- Participation in an organized weight reduction programme or pharmacological treatment for weight loss within the last 3 months
- Daily use of meal replacement products within the last 3 months
- Previous gastric surgery
- Current gastric, duodenal or oesophageal ulcers
- Inflammatory disease of the gastrointestinal tract including oesophagitis, or specific inflammation such as Crohn's disease
- Known potential upper gastrointestinal bleeding conditions such as gastric or oesophageal varices
- Known structural abnormalities of the pharynx or oesophagus
- Symptoms suggestive for severe gastric motility disorder
- Known hiatus hernia ≥ 5 cm
- Cancer diagnosed within the last 5 years or ongoing treatment for cancer (except non-metastasising skin cancer)
- Known severe heart failure (NYHA 3-4)
- Known chronic obstructive pulmonary disease (FEV1 ≤ 50 percent)
- Kidney failure (eGFR ≤ 30 ml/min)
- Liver failure (liver enzymes more than 3 times the normal threshold)
- Known proliferative retinopathy
- Known or suspected abuse of alcohol or narcotics
- Current or history of systemic treatment with corticosteroids within the last 3 months
- Known myocardial infarction or stroke within the last 6 months
- Current or history of pancreatitis
- Pregnancy, intention to become pregnant or breastfeeding during the study
- Untreated or insufficient treated hypo- or hyperthyroidism
- Current use of anticoagulants: warfarin, apixaban, dabigatran, edoxaban and rivaroxaban
- Current use of thrombocyte aggregation inhibitors: clopidogrel and acetylsalicylic acid
- Known or previous eating disorder
- Antimicrobial treatment within 3 months prior to study may lead to postponed participation
- Regular consumption of probiotic capsules within 1 month prior to study start may lead to postponed participation
- Participants considered to be unsuitable for the study by the investigator (e.g. serious psychiatric disorders, suspected eating disorders)
Sites / Locations
- Medicinmottagning 5/Överviktsenheten, University Hospital ÖrebroRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
IGB group
Arm Description
All participants in the control group are treated with LED and CBT-based group treatment as described below. All participants (control and intervention) receive 2.5-hour sessions of CBT-based group treatment every 4 weeks for 1 year. Participants are randomly assigned to groups of 8-16 participants. Two groups of about the same size start simultaneously. The LED phase (from baseline to 24 weeks) consists of 12 weeks with 4 portions/day of liquid meal replacements, for a total of 800-880 kcal/day, followed by a 12-week slow phasing out to a regular diet. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended.
All participants in the IGB group are treated with LED and CBT-based group treatment as described for the control group. Participants in the intervention group are treated with an IGB for 6 months from 6 months from start.
Outcomes
Primary Outcome Measures
Weight loss in percent of total body weight
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Secondary Outcome Measures
Weight loss in percent of total body weight
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Weight loss in percent of total body weight at 2-year follow-up
Two years after treatment start and thus one year after completion of the intervention, participants will be followed up on total body weight. Weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
The proportion of participants with ≥5 percent reduction of total body weight from baseline
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
The proportion of participants with ≥10 percent reduction of total body weight from baseline
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
The proportion of participants with ≥15 percent reduction of total body weight from baseline
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Effect of treatment on bioelectrical impedance measurement to assess fat mass
Bioelectrical impedance analysis is performed with a Body Composition Analyzer BC-420MA. Fatt mass is estimated and results are presented in kilograms.
Effect of treatment on bioelectrical impedance measurement to assess muscle mass
Bioelectrical impedance analysis is performed with a Body Composition Analyzer BC-420MA. Muscle mass is estimated and results are presented in kilograms.
Change in waist circumference
Waist circumference is measured in centimeters according to the World Health Organization protocol.
Change in 2-hour oral glucose tolerance test
Effect on the 2-hour oral glucose tolerance test (OGTT) is measured by analysing glucose (mmol/L) in a fasting blood sample. Thereafter the participant drinks a standardized amount of glucose. After 120 minutes, a blood sample is analyzed again for glucose (mmol/L) .
Change in Hemoglobin A1c
Hemoglobin A1c (HbA1c) in mmol/L is analyzed in a fasting blood sample.
Change in serum lipids
Total cholesterol, HDL, LDL and triglycerides are analyzed in a fasting blood sample. Results are presented in mmol/L.
Change in insulin
Insulin is analyzed in a fasting blood sample and presented in mIE/L.
Change in Homeostatic Model Assessment of Insulin Resistance
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is calculated using fasting values of insulin and glucose.
Change in kidney function
Kidney function is assessed by analysing blood samples for creatinine (µmol/L). The result is used to calculate the estimated glomerular filtration rate (eGFR) using the Lund-Malmö revised calculation. eGFR is presented as mL/min/1,73m^2.
Change in liver transaminases
Liver transaminases are measured by analysing alanine transaminase (ALT) and aspartate transaminase (AST) in a fasting blood sample. Data is presented in µkat/L.
Change in thrombocytes
Thrombocytes are analyzed in a fasting blood sample and presented as 10*9/L.
Change in blood pressure
Blood pressure is measured using a correct cuff size for the circumference of participant's arm after 5 minutes rest in a sitting position.
Effect of treatment on vibration-controlled transient elastography measurement to assess level of liver steatosis and fibrosis
Evaluation of NAFLD at baseline and effect of treatment using vibration-controlled transient elastography to detect liver stiffness (in kPa) and determine the steatosis and fibrosis score (0 to 4 there 0 means no steatosis or fibrosis).
Effect of treatment on RAND-36 (SF-36) to measure QoL
RAND-36 (SF-36) questionnaire is validated to measure QoL and comprises 36 items measuring eight domains that reflect a wide spectrum of physical and mental health aspects: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.
Effect of treatment on the Obesity-related Problems scale, version 3 (OPv3) to measure weight-related psychosocial functioning
OPv3 is validated to measure obesity-specific quality of life with 26 items. OP measures the negative effects of obesity on psychosocial functioning.
Effects of treatment on the Three-Factor Eating Questionnaire-Revised 18 (TFEQ-R18V2) items to measure eating behavior
The TFEQ-R18V2 is a validated questionnaire to measure three aspects of eating behavior: uncontrolled eating (9 items), cognitive restraint (3 items), and emotional eating (6 items).
Effects of treatment on hunger and satiety
Hunger and satiety are assessed by a questionnaire with 9 single items on a 5-point Likert scale.
Effect of treatment on 7-day step count to measure physical activity
Step count is measured during 7 consecutive days using an accelerometer. The data is completed with questions on water-based activities and cycling on these days.
Effect of treatment on sitting time and physical activity
Self-reported data on physical activity will be measured by a validated questionnaire from the National Board of Health and Welfare, Sweden, concerning sitting time and hours of light and moderate activity.
Effect of treatment on the use of medication for glucose lowering treatment, hypertension and hyperlipidemia
Effect of treatment on the use of medication for glucose lowering treatment, hypertension and hyperlipidemia is assessed by asking participants at every study contact, if changes in medication have been made. A patient record survey for prescribed medication is performed at 12 and 24 months.
The effect of treatment on the use of health care and absence from work during treatment
Health care utilization and absence from work are measured with self-assessment questionnaires. A patient record survey is performed at 12 and 24 months.
Calculation of cost-effectiveness of treatment using multi-variable analysis
Cost-effectiveness is analyzed using data on health care utilization, absence from work, use of medication and QoL questionnaires (RAND-36 and OPv3). Data is combined and analyzed together to calculate and report cost-effectiveness. All used measurements are also described above as separate secondary outcome measures.
Full Information
NCT ID
NCT04230655
First Posted
December 30, 2019
Last Updated
January 14, 2020
Sponsor
Region Örebro County
1. Study Identification
Unique Protocol Identification Number
NCT04230655
Brief Title
Weight Loss in Adults With Obesity Using a Combination of Low Energy Diet, Group Treatment and Intragastric Balloon
Official Title
The Effects of a Low Energy Diet Versus Low Energy Diet and Intragastric Balloon in Adults With Obesity, All in Combination With Group Treatment: a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Örebro County
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
In Sweden, approximately 1.3 million adults have obesity. Obesity decreases quality of life (QoL) and increases the risk of diseases such as type 2-diabetes, non-alcoholic fatty liver disease (NAFLD), cancer and cardiovascular diseases. Consequently, weight loss improves QoL and decreases the risk for obesity-related comorbidities.
A treatment combination using a low energy diet (LED) and group treatment based on cognitive behavioral therapy (CBT), leads to 18 percent weight loss after 6 months. Six months treatment with an intragastric balloon (IGB) leads to 13 percent weight loss. However, both treatments are usually followed by weight regain. Combining these treatments has not been studied before but could lead to better weight maintenance.
The hypothesis is that treatment of adults with obesity, with LED, CBT and IGB, leads to greater weight loss after 1 year compared to treatment with LED and CBT only.
The study is a randomized, controlled clinical trial, with a 2-year follow-up. One hundred and ten adults, age 30-65 years, with a BMI of 30-45 kg/m^2 will be included. All participants will receive 6 months of LED, followed by randomization to either 6 months with IGB or a control group without IGB. All participants receive CBT-based group treatment during 12 months and followed up after 2 years.
If the treatment combination of LED, CBT and IGB leads to significant weight loss and improved weight maintenance, increased QoL and reductions of comorbidities and costs of health care are expected. Effects of treatment on eating behavior, NAFLD, physical activity, psychological parameters, the gut microbiota, gut permeability and metabolomics will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss, Non-Alcoholic Fatty Liver Disease
Keywords
Obesity, Weight loss, Low energy diet, Intragastric balloon, Group treatment, Non-alcoholic fatty liver disease, Quality of life, Body weight, Glucose metabolism, Eating behavior, Microbiomics, Physical activity, Gastrointestinal symptoms, Psychological parameters
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study design is an open labelled, randomized, controlled clinical trial, with a ratio 1:1.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
All participants in the control group are treated with LED and CBT-based group treatment as described below.
All participants (control and intervention) receive 2.5-hour sessions of CBT-based group treatment every 4 weeks for 1 year. Participants are randomly assigned to groups of 8-16 participants. Two groups of about the same size start simultaneously.
The LED phase (from baseline to 24 weeks) consists of 12 weeks with 4 portions/day of liquid meal replacements, for a total of 800-880 kcal/day, followed by a 12-week slow phasing out to a regular diet. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended.
Arm Title
IGB group
Arm Type
Experimental
Arm Description
All participants in the IGB group are treated with LED and CBT-based group treatment as described for the control group.
Participants in the intervention group are treated with an IGB for 6 months from 6 months from start.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low energy diet using meal replacements
Other Intervention Name(s)
LED
Intervention Description
The LED phase (from baseline to 24 weeks) consists of 12 weeks with 4 portions/day of liquid meal replacements, for a total of 800-880 kcal/day, followed by a 12-week slow phasing out to a regular diet. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended.
Intervention Type
Behavioral
Intervention Name(s)
CBT-based group treatment
Other Intervention Name(s)
CBT
Intervention Description
All participants (control and intervention) receive 2.5-hour sessions of CBT-based group treatment every 4 weeks for 1 year. Participants are randomly assigned to groups of 8-16 participants.
Intervention Type
Device
Intervention Name(s)
Intragastric balloon
Other Intervention Name(s)
IGB
Intervention Description
An IGB (Orbera IGB, Apollo Endosurgery Inc., Austin, Texas, (CE certified)) is set in place endoscopically by a gastroenterologist at Örebro University Hospital, Region Örebro county, and is left in the stomach for 6 months. A proton-pump inhibitor is prescribed to counteract an increased risk to develop a gastric ulcer. During the first 2 weeks, dietary adjustments are necessary to adapt to the IGB. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended identical to the control group. The IGB is removed endoscopically after 6 months IGB treatment.
Primary Outcome Measure Information:
Title
Weight loss in percent of total body weight
Description
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Time Frame
Change from baseline at 12 months
Secondary Outcome Measure Information:
Title
Weight loss in percent of total body weight
Description
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Time Frame
Change from baseline at 6 months
Title
Weight loss in percent of total body weight at 2-year follow-up
Description
Two years after treatment start and thus one year after completion of the intervention, participants will be followed up on total body weight. Weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Time Frame
Change from baseline at 24 months
Title
The proportion of participants with ≥5 percent reduction of total body weight from baseline
Description
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Time Frame
6, 12 and 24 months
Title
The proportion of participants with ≥10 percent reduction of total body weight from baseline
Description
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Time Frame
6, 12 and 24 months
Title
The proportion of participants with ≥15 percent reduction of total body weight from baseline
Description
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Time Frame
6, 12 and 24 months
Title
Effect of treatment on bioelectrical impedance measurement to assess fat mass
Description
Bioelectrical impedance analysis is performed with a Body Composition Analyzer BC-420MA. Fatt mass is estimated and results are presented in kilograms.
Time Frame
Change from baseline at 6, 12 and 24 months
Title
Effect of treatment on bioelectrical impedance measurement to assess muscle mass
Description
Bioelectrical impedance analysis is performed with a Body Composition Analyzer BC-420MA. Muscle mass is estimated and results are presented in kilograms.
Time Frame
Change from baseline at 6, 12 and 24 months
Title
Change in waist circumference
Description
Waist circumference is measured in centimeters according to the World Health Organization protocol.
Time Frame
Change from baseline at 6, 12 and 24 months
Title
Change in 2-hour oral glucose tolerance test
Description
Effect on the 2-hour oral glucose tolerance test (OGTT) is measured by analysing glucose (mmol/L) in a fasting blood sample. Thereafter the participant drinks a standardized amount of glucose. After 120 minutes, a blood sample is analyzed again for glucose (mmol/L) .
Time Frame
Change from baseline at 6 and 12 months
Title
Change in Hemoglobin A1c
Description
Hemoglobin A1c (HbA1c) in mmol/L is analyzed in a fasting blood sample.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in serum lipids
Description
Total cholesterol, HDL, LDL and triglycerides are analyzed in a fasting blood sample. Results are presented in mmol/L.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in insulin
Description
Insulin is analyzed in a fasting blood sample and presented in mIE/L.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in Homeostatic Model Assessment of Insulin Resistance
Description
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is calculated using fasting values of insulin and glucose.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in kidney function
Description
Kidney function is assessed by analysing blood samples for creatinine (µmol/L). The result is used to calculate the estimated glomerular filtration rate (eGFR) using the Lund-Malmö revised calculation. eGFR is presented as mL/min/1,73m^2.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in liver transaminases
Description
Liver transaminases are measured by analysing alanine transaminase (ALT) and aspartate transaminase (AST) in a fasting blood sample. Data is presented in µkat/L.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in thrombocytes
Description
Thrombocytes are analyzed in a fasting blood sample and presented as 10*9/L.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in blood pressure
Description
Blood pressure is measured using a correct cuff size for the circumference of participant's arm after 5 minutes rest in a sitting position.
Time Frame
Change from baseline at 6 and 12 months
Title
Effect of treatment on vibration-controlled transient elastography measurement to assess level of liver steatosis and fibrosis
Description
Evaluation of NAFLD at baseline and effect of treatment using vibration-controlled transient elastography to detect liver stiffness (in kPa) and determine the steatosis and fibrosis score (0 to 4 there 0 means no steatosis or fibrosis).
Time Frame
Change from baseline at 6 and 12 months
Title
Effect of treatment on RAND-36 (SF-36) to measure QoL
Description
RAND-36 (SF-36) questionnaire is validated to measure QoL and comprises 36 items measuring eight domains that reflect a wide spectrum of physical and mental health aspects: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.
Time Frame
Change from baseline at 6, 12 and 24 months
Title
Effect of treatment on the Obesity-related Problems scale, version 3 (OPv3) to measure weight-related psychosocial functioning
Description
OPv3 is validated to measure obesity-specific quality of life with 26 items. OP measures the negative effects of obesity on psychosocial functioning.
Time Frame
Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks
Title
Effects of treatment on the Three-Factor Eating Questionnaire-Revised 18 (TFEQ-R18V2) items to measure eating behavior
Description
The TFEQ-R18V2 is a validated questionnaire to measure three aspects of eating behavior: uncontrolled eating (9 items), cognitive restraint (3 items), and emotional eating (6 items).
Time Frame
Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks
Title
Effects of treatment on hunger and satiety
Description
Hunger and satiety are assessed by a questionnaire with 9 single items on a 5-point Likert scale.
Time Frame
Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks
Title
Effect of treatment on 7-day step count to measure physical activity
Description
Step count is measured during 7 consecutive days using an accelerometer. The data is completed with questions on water-based activities and cycling on these days.
Time Frame
Change from baseline at 6, 12 and 24 months
Title
Effect of treatment on sitting time and physical activity
Description
Self-reported data on physical activity will be measured by a validated questionnaire from the National Board of Health and Welfare, Sweden, concerning sitting time and hours of light and moderate activity.
Time Frame
Change from baseline at 6, 12 and 24 months
Title
Effect of treatment on the use of medication for glucose lowering treatment, hypertension and hyperlipidemia
Description
Effect of treatment on the use of medication for glucose lowering treatment, hypertension and hyperlipidemia is assessed by asking participants at every study contact, if changes in medication have been made. A patient record survey for prescribed medication is performed at 12 and 24 months.
Time Frame
Change from baseline at 6, 12 and 24 months
Title
The effect of treatment on the use of health care and absence from work during treatment
Description
Health care utilization and absence from work are measured with self-assessment questionnaires. A patient record survey is performed at 12 and 24 months.
Time Frame
Change from baseline at 6, 12 and 24 months
Title
Calculation of cost-effectiveness of treatment using multi-variable analysis
Description
Cost-effectiveness is analyzed using data on health care utilization, absence from work, use of medication and QoL questionnaires (RAND-36 and OPv3). Data is combined and analyzed together to calculate and report cost-effectiveness. All used measurements are also described above as separate secondary outcome measures.
Time Frame
Change from baseline at 6, 12 and 24 months
Other Pre-specified Outcome Measures:
Title
Comparison of the calculated risk for liver fibrosis using the fibrosis-4 (FIB-4) calculation to prevalence of liver fibrosis in the study population detected by vibration-controlled transient elastography
Description
The risk for liver fibrosis is calculated using the FIB-4 calculation (ALT, AST, thrombocytes and age) and compared with results of vibration-controlled transient elastography on prevalence of liver steatosis and fibrosis.
Time Frame
At baseline, 6 and 12
Title
Effect of treatment on lipidomics
Description
Evaluation of NAFLD by analysing lipidomic signatures using mass spectrometry based lipidomics.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in gut microbiota compositions during treatment with LED, re-introduction of the recommended diet and treatment with IGB
Description
Stool samples are taken and will be analyzed for quantitative and qualitative microbial composition by using next generation metagenomic sequencing.
Time Frame
Change from baseline at 2, 4, 6, 9 and 12 months
Title
Food frequency questionnaires to evaluate change in dietary intake
Description
Food frequency questionnaires (FFQ) will be used to assess dietary intake. This is a common way to evaluate eating habits and, in this way, evaluation of the gut microbiota composition in relation to dietary patterns is possible to assess.
Time Frame
Change from baseline, 6 and 12 months
Title
The Bristol Stool Form Scale is used to asses stool form
Description
The Bristol Stool Form Scale (BSFS) is used to asses stool form at the same time points as the collection of stool samples. The scale shows 7 pictures of different forms of stool, from watery diarrhea to compact. Participants are asked to choose the most frequent form of stool they have had the past week.
Time Frame
Change from baseline at 2, 4, 6, 9 and 12 months
Title
Change in Glucagon-like peptide-1
Description
Glucagon-like peptide-1 (GLP-1) is analysed in a fasting blood sample. Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of hormonal parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in Glucagon-like peptide-2
Description
Glucagon-like peptide-2 (GLP-2) is analysed in a fasting blood sample. Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of hormonal parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in peptide YY
Description
Peptide YY (PYY) is analysed in a fasting blood sample. Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of hormonal parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in leptin
Description
Leptin is analysed in a fasting blood sample. Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of hormonal parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in ghrelin
Description
Ghrelin is analysed in a fasting blood sample. Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of hormonal parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in pro-insulin
Description
Pro-insulin is analysed in a fasting blood sample. Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of hormonal parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in C-peptide
Description
C-peptide is analysed in a fasting blood sample. Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of hormonal parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in glucagon
Description
Glucagon is analysed in a fasting blood sample. Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of hormonal parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in adiponectin
Description
Adiponectin is analysed in a fasting blood sample. Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of hormonal parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in glycerol
Description
Glycerol is analysed in a fasting blood sample. Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of hormonal parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Change in free fatty acid
Description
Free fatty acid (FFA) is analysed in a fasting blood sample.
Time Frame
Change from baseline at 6 and 12 months
Title
Effect of treatment on highly sensitive C-reactive protein
Description
Highly sensitive C-reactive protein (hs-CRP) is analysed in mg/L as a measure for inflammation.
Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of inflammatory parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Effect of treatment on Interleukin-6
Description
Interleukin-6 (IL-6) is analysed as a measure for inflammation. Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of inflammatory parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Effect of treatment on Tumor Necrosis Factor-alfa
Description
Tumor Necrosis Factor-alfa (TNF-alfa) is analysed as a measure for inflammation. tumor necrosis factor (TNF)-alfa, and Plasminogen activator inhibitor-1 (PAI-1).
Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of inflammatory parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Effect of treatment on Plasminogen Activator Inhibitor-1
Description
Plasminogen activator inhibitor-1 (PAI-1) is analysed as a measure for inflammation.
Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of inflammatory parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Effect of treatment on metabolomics
Description
Changes in metabolomics are assessed by mass spectrometry based approaches for global analysis of molecular lipids (lipidomics) and polar metabolites. Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of metabolic parameters in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Effect of treatment on Zonulin
Description
Zonulin is analysed in a fasting blood sample as a measure for gut permeability. Extra plasma and serum will be collected in a biobank to be able to make use of expected new developed and validated analysis of gut permeability in the coming years.
Time Frame
Change from baseline at 6 and 12 months
Title
Gastrointestinal Symptom Rating Scale to assess gastrointestinal symptoms
Description
The Gastrointestinal Symptom Rating Scale (GSRS) is an instrument with 15-items validated to assess gastro-intestinal (GI) symptoms associated with GI disorders. It contains 5 subscales (Reflux, Diarrhea, Constipation, Abdominal Pain, and Indigestion Syndrome). The scores per subscale range from 1 to 7. Higher scores represent more discomfort.
Time Frame
Baseline, 4, 12, 20, 24, 28, 36, 44 and 52 weeks
Title
Visceral Sensitivity Index to assess fear of gastrointestinal symptoms
Description
The Visceral Sensitivity Index (VSI) measures GI symptom-specific anxiety and comprises 15 items.
Time Frame
Baseline, 4, 12, 20, 24, 28, 36, 44 and 52 weeks
Title
Nepean Dyspepsia Index to assess dyspepsia
Description
The Short form-Nepean dyspepsia index measures upper GI symptoms with 10 items.
Time Frame
Baseline, 4, 12, 20, 24, 28, 36, 44 and 52 weeks
Title
Rome IV criteria to assess symptoms for irritable bowel syndrome
Description
Rome IV is a diagnostic questionnaire for functional GI disorders, and comprises of 89 items in a flowchart.
Time Frame
Baseline, 6 and 12 months
Title
13C Spirulina Breath test to assess gastric emptying rate in participants randomized to IGB treatment
Description
Gastric emptying rate is measured prior to IGB placement in participants randomized to IGB. Gastric emptying rate will be measured using the FDA-approved non-invasive, non-radioactive 13C Spirulina Breath test (Cairn Diagnostics, Brentwood, Tennessee, USA).
Time Frame
1 to 28 days before IGB placement
Title
Analysis of number and causes of early extractions of the gastric balloon to asses tolerability of IGB treatment
Description
The number of participants in need of an early extraction of the IGB, thus prior to 6 months treatment, is assessed. The cause for early removal is assessed.
Specifically, possible causes for intolerability are assessed by combining data on gastric-emptying, the need for early extraction of the IGB (within 6 months), gastro-intestinal symptoms using 4 questionnaires (GSRS, Rome-IV, VSI and Nepean) and two QoL questionnaires (RAND-36 and OP). All these parameters are also described as separate outcome measures.
Time Frame
24, 28, 36, 44 and 52 weeks
Title
Change in Depression Module (PHQ-9) questionnaire
Description
PHQ-9 is used to assess effect of psychological parameters on treatment results and tolerability. To analyze effect of psychological parameters on treatment results, data analyses will combine this data with treatment effect on weight, gastrointestinal symptoms and QoL.
Time Frame
Change from baseline at 4, 12, 20, 24, 28, 36, 44 and 52 weeks
Title
Change in Anxiety module (GAD-7) questionnaire
Description
GAD-7 is used to assess effect of psychological parameters on treatment results and tolerability. To analyze effect of psychological parameters on treatment results, data analyses will combine this data with treatment effect on weight, gastrointestinal symptoms and QoL.
Time Frame
Change from baseline at 4, 12, 20, 24, 28, 36, 44 and 52 weeks
Title
Change in Somatic symptom severity ('somatization') module (PHQ-15) questionnaire
Description
PHQ-15 is used to assess effect of psychological parameters on treatment results and tolerability.To analyze effect of psychological parameters on treatment results, data analyses will combine this data with treatment effect on weight, gastrointestinal symptoms and QoL.
Time Frame
Change from baseline at 6 and 12 months
Title
Pittsburgh Sleep Quality Index to assess sleep quality
Description
Change in sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI).
Time Frame
Change from baseline at 4, 12, 20, 24, 28, 36, 44 and 52 weeks
Title
Acceptance and Action Questionnaire for Weight-Related Difficulties
Description
Acceptance and Action Questionnaire for Weight-Related Difficulties (AAQ-W) measures experimental and psychological inflexibility in relation to weight-related feelings, thoughts and actions.
Time Frame
Change from baseline at 4, 12, 20, 24, 28, 36, 44 and 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI ≥ 30 and ≤45 kg/m^2
Age 30 to 65 years
Exclusion Criteria:
Participation in an organized weight reduction programme or pharmacological treatment for weight loss within the last 3 months
Daily use of meal replacement products within the last 3 months
Previous gastric surgery
Current gastric, duodenal or oesophageal ulcers
Inflammatory disease of the gastrointestinal tract including oesophagitis, or specific inflammation such as Crohn's disease
Known potential upper gastrointestinal bleeding conditions such as gastric or oesophageal varices
Known structural abnormalities of the pharynx or oesophagus
Symptoms suggestive for severe gastric motility disorder
Known hiatus hernia ≥ 5 cm
Cancer diagnosed within the last 5 years or ongoing treatment for cancer (except non-metastasising skin cancer)
Known severe heart failure (NYHA 3-4)
Known chronic obstructive pulmonary disease (FEV1 ≤ 50 percent)
Kidney failure (eGFR ≤ 30 ml/min)
Liver failure (liver enzymes more than 3 times the normal threshold)
Known proliferative retinopathy
Known or suspected abuse of alcohol or narcotics
Current or history of systemic treatment with corticosteroids within the last 3 months
Known myocardial infarction or stroke within the last 6 months
Current or history of pancreatitis
Pregnancy, intention to become pregnant or breastfeeding during the study
Untreated or insufficient treated hypo- or hyperthyroidism
Current use of anticoagulants: warfarin, apixaban, dabigatran, edoxaban and rivaroxaban
Current use of thrombocyte aggregation inhibitors: clopidogrel and acetylsalicylic acid
Known or previous eating disorder
Antimicrobial treatment within 3 months prior to study may lead to postponed participation
Regular consumption of probiotic capsules within 1 month prior to study start may lead to postponed participation
Participants considered to be unsuitable for the study by the investigator (e.g. serious psychiatric disorders, suspected eating disorders)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marije Galavazi, PhD, MD
Phone
+46196026631
Email
marije.galavazi@regionorebrolan.se
First Name & Middle Initial & Last Name or Official Title & Degree
Johan Jendle, Professor
Phone
+46709571257
Email
johan.jendle@oru.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Jendle, Professor
Organizational Affiliation
johan.jendle@oru.se
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicinmottagning 5/Överviktsenheten, University Hospital Örebro
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marije Galavazi, PhD, MD
Phone
+46196026631
Email
marije.galavazi@regionorebrolan.se
First Name & Middle Initial & Last Name & Degree
Kristina Sigvardsson, Study nurse
Phone
+46196026635
Email
kristina.sigvardsson@regionorebrolan.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Weight Loss in Adults With Obesity Using a Combination of Low Energy Diet, Group Treatment and Intragastric Balloon
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