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Metabolic Changes After Bariatric Surgery

Primary Purpose

Grade III Obesity, Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Laparoscopic sleeve gastrectomy
Laparoscopic gastric plication
Intragastric balloon
Intragastric balloon implantation
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Grade III Obesity focused on measuring Obesity, Bariatric medicine, Sleeve gastric resection, Gastric plication, Intragastric ballon, Body composition, Adipokines, Ghrelin, Bone mineral density, Quality of life

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of conservative obesity treatments selected according to criteria IFSO (BMI greater than 40 or greater than 35 with comorbidities)

Exclusion Criteria:

  • Thyroid disease
  • Diseases of the digestive system associated with disorders of intestinal absorption
  • History of corticosteroid therapy in the past 12 months

Sites / Locations

  • Vítkovice Hospital Ostrava
  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Laparoscopic sleeve gastrectomy

Laparoscopic gastric plication

Intragastric balloon

Arm Description

Patients undergoing bariatric surgery procedure of laparoscopic sleeve gastrectomy.

Patients undergoing bariatric surgery procedure of laparoscopic gastric plication.

Patients undergoing bariatric surgery procedure with intragastric balloon implantation.

Outcomes

Primary Outcome Measures

Changes in serum levels of adipose tissue hormones
To analyze the dynamics of changes in serum levels of adipose tissue hormones (Leptin, Adiponectin) in adults after bariatric treatment of malignant obesity (BMI> 35). Points of measurements: before the planned intervention and then in intervals of 3, 6, 12, and 18 months after procedure.
Changes in serum levels of lipids
To analyze the dynamics of changes in serum levels of lipids in adults after bariatric treatment of malignant obesity (BMI> 35). In the study, serum concentrations of the following lipids will be measured: tricylglycerols, total cholesterol, high-density lipoprotein, low-density lipoprotein cholesterol, Apo D and Apo E. The measurements will be performed before the planned intervention and then in intervals at 3, 6, 12, and 18 months after the procedure. The results will be presented in respective units (mmol/L, mg/dL, etc.).
Changes in serum levels of osteomarkers
To analyze the dynamics of changes in serum levels of usual panel of osteomarkers in adults after bariatric treatment of malignant obesity (BMI> 35). The following serum levels markers of bone resorption and formation will be assessed: CTx, P1NP, ALP, RANKL, FGF 23, Osteocalcin, Osteopontin and vitamin D2 and D3. The measurements will be performed before the planned intervention and then in intervals at 3, 6, 12, and 18 months after the procedure. The results will be presented in respective units (mmol/L, mg/dL, etc.).
IWQOL Questionnaire evaluation
Evaluation of effects of different types of bariatric interventions on quality of life will be performed by using the IWQOL questionnaire. Improvement from baseline quality of life as measured by standardized IWQOL patient questionnaire (http://www.qualityoflifeconsulting.com/iwqol-lite.html) intended to measure the patient health status.
SF-36 Questionnaire evaluation
Evaluation of effects of different types of bariatric interventions on quality of life will be performed using the SF-36 questionnaire. Improvement from baseline quality of life as measured by standardized SF-36 patient questionnaire intended to measure the patient health status.

Secondary Outcome Measures

Long-term weight reduction assessment in kgs
Evaluation of the success of treatment in terms of long-term weight reduction (difference in body weight in kilograms at the beginning vs. the end of the observation period of 18 months), expressed as TBL (total body weight loss), EWL (excess weight loss), and EBL (excess BMI loss).
Effectiveness evaluation
Evaluation of the effectiveness of the specified bariatric procedures, including new intragastric balloons. The following parameters will be assessed at 3, 6, and 12 months: 1) Per cent total body weight loss and excess weight loss at 12 months, 2) Changes in fasting glycaemia, insulin and hemoglobin A1C at 12 months; 3) Reduction in diabetes medication requirements (for diabetic cohort) at 12 months, and 4) Occurrence rate of serious adverse events judged to be probably or definitely related to the study device.

Full Information

First Posted
February 24, 2016
Last Updated
March 22, 2018
Sponsor
University Hospital Ostrava
Collaborators
University of Ostrava, Vitkovice Hospital, Ostrava, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT02893891
Brief Title
Metabolic Changes After Bariatric Surgery
Official Title
Metabolic Changes of Fat and Bone Tissue After Radical Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
Collaborators
University of Ostrava, Vitkovice Hospital, Ostrava, Czech Republic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Literature data clearly demonstrate that treatment of obese patients is very expensive, long and achieve weight loss may not be permanent, and regardless of whether the treatment dominated diet therapy, physical activity, or pharmacotherapy. Experience of the last decade has shown that after surgical interventional treatment of obesity occurs not only long-term (10 years and over) weight loss of 35-40%, but also an important endocrine changes. In recent years, it was discovered a number of signaling molecules produced by adipose tissue, whose physiological significance beyond the general metabolic aspects organism. The fat is therefore currently understood as an endocrine organ whose hormones modulate the function of many systems, including the skeleton. These hormones include the adipokines that modulate metabolism skeleton as at tissue level (Leptin, Adiponectin) and indirectly - by activation of neurohumoral hypothalamic centers - Leptin. Studying endocrine interactions between adipose tissue and bone is a highly topical issue. This mutual communication is a homeostatic feedback system in which adipokines and molecules secreted by osteoblasts and osteoclasts are the connecting link active axes fat - bone tissue. However, the mechanisms of this axis remain largely unknown.
Detailed Description
Obesity is an important medical problem. The number of obese individuals is increasing continuously in response to various environmental and genetic factors. For some morbidly obese patients, surgery is the only effective type of therapy. Despite bariatric surgery having good outcomes in terms of weight loss, it is associated with some adverse effects: several studies have reported subsequent alterations in bone metabolism. Of the surgical techniques available (laparoscopic gastric banding, Roux-en-Y bypass, biliopancreatic diversion), laparoscopic sleeve gastrectomy (LSG) is currently the technique of choice. Because restrictive procedures such as LSG do not involve bypassing segments of small bowel where micronutrient absorption takes place, fewer metabolic disturbances are expected than with other surgical techniques. The observed changes in bone metabolism and status in post-bariatric surgery patients potentially involve several mechanisms, including reduced absorption of essential nutrients, diminished calcium absorption leading to secondary hyperparathyroidism, poor vitamin D absorption and restricted energy delivery. In addition, body weight protects against osteoporosis via the bone-strengthening effects of long-term weight bearing. However, long-term decreases in bone mineral density in patients who have undergone successful bariatric surgery are an unexpected, negative effect of this type of therapy. In the study, parameters of fat and bone tissue and body composition changes are assessed in groups of bariatric patients after LSG, gastric plication and intragastric balloon treatment. Other anticipated benefits of the study treatment include improving the quality of life of. lt will also lead to the introduction of new processes, materials and methods. lt is also possible to expect shortening of the hospital stay, decrease in postoperative morbidity, and the possibility to perform the procedure on an outpatient basis. The study has been designed as a prospective study, which is in conformity with the principles and guidelines of the Helsinki Declaration, good clinical practice and has been approved by the Ethical Committee of the Faculty of Medicine, University of Ostrava. The patients enrolled in the study are followed for the period of twelve months. Timetable of the study procedures and controls: Preoperative examination: Demographic data on age, sex, weight, height, smoking Assessment of body composition and sampling of blood Questionnaires for quality of Life Examination 3 months postoperatively Assessment of body composition and sampling of blood Questionnaires for quality of Life Examination 6 months after surgery Assessment of body composition and sampling of blood Questionnaires for quality of Life Examination 12 months after surgery Assessment of body composition and sampling of blood Questionnaires for quality of Life Statistical data processing for statistical evaluation descriptive statistics are used (arithmetical average, standard deflection, frequency tables), X2 test, Fisher's exact test, analysis of variance (ANOVA), calculating of the OR (odds ratio) with 95 % confidence intervals, and logistic regression. Statistical tests are evaluated at the significance level of 5%. Statistical analysis is performed in the "Stata 10" programme. Program EpiData is used for data collection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grade III Obesity, Type 2 Diabetes Mellitus
Keywords
Obesity, Bariatric medicine, Sleeve gastric resection, Gastric plication, Intragastric ballon, Body composition, Adipokines, Ghrelin, Bone mineral density, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
Patients undergoing bariatric surgery procedure of laparoscopic sleeve gastrectomy.
Arm Title
Laparoscopic gastric plication
Arm Type
Active Comparator
Arm Description
Patients undergoing bariatric surgery procedure of laparoscopic gastric plication.
Arm Title
Intragastric balloon
Arm Type
Active Comparator
Arm Description
Patients undergoing bariatric surgery procedure with intragastric balloon implantation.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sleeve gastrectomy
Intervention Description
Sleeve gastrectomy involves removing most of the stomach, limiting the amount of food the patient can eat.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic gastric plication
Intervention Description
Laparoscopic gastric plication involves sewing one or more large folds in the stomach. During the laparoscopic gastric plication, the stomach volume is reduced about 70%, which makes the stomach able to hold less and helps the patient eat less.
Intervention Type
Procedure
Intervention Name(s)
Intragastric balloon
Intervention Description
The introduction of the balloon is non-invasive as it is inserted endoscopically (down the oesophagus). The balloon is then filled inside the stomach with a dyed physiological solution, which reduces the volume of the stomach.
Intervention Type
Device
Intervention Name(s)
Intragastric balloon implantation
Intervention Description
Intragastric balloons (End-Ball, Medsil) will be implanted in the patients with morbid obesity.
Primary Outcome Measure Information:
Title
Changes in serum levels of adipose tissue hormones
Description
To analyze the dynamics of changes in serum levels of adipose tissue hormones (Leptin, Adiponectin) in adults after bariatric treatment of malignant obesity (BMI> 35). Points of measurements: before the planned intervention and then in intervals of 3, 6, 12, and 18 months after procedure.
Time Frame
18 months
Title
Changes in serum levels of lipids
Description
To analyze the dynamics of changes in serum levels of lipids in adults after bariatric treatment of malignant obesity (BMI> 35). In the study, serum concentrations of the following lipids will be measured: tricylglycerols, total cholesterol, high-density lipoprotein, low-density lipoprotein cholesterol, Apo D and Apo E. The measurements will be performed before the planned intervention and then in intervals at 3, 6, 12, and 18 months after the procedure. The results will be presented in respective units (mmol/L, mg/dL, etc.).
Time Frame
18 months
Title
Changes in serum levels of osteomarkers
Description
To analyze the dynamics of changes in serum levels of usual panel of osteomarkers in adults after bariatric treatment of malignant obesity (BMI> 35). The following serum levels markers of bone resorption and formation will be assessed: CTx, P1NP, ALP, RANKL, FGF 23, Osteocalcin, Osteopontin and vitamin D2 and D3. The measurements will be performed before the planned intervention and then in intervals at 3, 6, 12, and 18 months after the procedure. The results will be presented in respective units (mmol/L, mg/dL, etc.).
Time Frame
18 months
Title
IWQOL Questionnaire evaluation
Description
Evaluation of effects of different types of bariatric interventions on quality of life will be performed by using the IWQOL questionnaire. Improvement from baseline quality of life as measured by standardized IWQOL patient questionnaire (http://www.qualityoflifeconsulting.com/iwqol-lite.html) intended to measure the patient health status.
Time Frame
18 months
Title
SF-36 Questionnaire evaluation
Description
Evaluation of effects of different types of bariatric interventions on quality of life will be performed using the SF-36 questionnaire. Improvement from baseline quality of life as measured by standardized SF-36 patient questionnaire intended to measure the patient health status.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Long-term weight reduction assessment in kgs
Description
Evaluation of the success of treatment in terms of long-term weight reduction (difference in body weight in kilograms at the beginning vs. the end of the observation period of 18 months), expressed as TBL (total body weight loss), EWL (excess weight loss), and EBL (excess BMI loss).
Time Frame
18 months
Title
Effectiveness evaluation
Description
Evaluation of the effectiveness of the specified bariatric procedures, including new intragastric balloons. The following parameters will be assessed at 3, 6, and 12 months: 1) Per cent total body weight loss and excess weight loss at 12 months, 2) Changes in fasting glycaemia, insulin and hemoglobin A1C at 12 months; 3) Reduction in diabetes medication requirements (for diabetic cohort) at 12 months, and 4) Occurrence rate of serious adverse events judged to be probably or definitely related to the study device.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of conservative obesity treatments selected according to criteria IFSO (BMI greater than 40 or greater than 35 with comorbidities) Exclusion Criteria: Thyroid disease Diseases of the digestive system associated with disorders of intestinal absorption History of corticosteroid therapy in the past 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marek Bužga, MSc., Ph.D.
Organizational Affiliation
Faculty of Medicine, Ostrava University, Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vítkovice Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
703 00
Country
Czechia
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
708 52
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Metabolic Changes After Bariatric Surgery

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