Back to resultsEndoBarrier in Obese Subjects With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes, Obesity
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
EndoBarrier
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Type 2 diabetes
- BMI 30-49 kg/m²
- HbA1c ≥ 6.5% (48 mmol/mol)
- Appropriate life style intervention measures have been tried but have failed to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months
- Person is generally fit for intervention
- Person commits to the need for long-term follow-up
Exclusion Criteria:
- Type 1 diabetes mellitus
- Maturity Onset Diabetes of the Young (MODY)
- Secondary diabetes due to a specific disease or glucocorticoid therapy
- Pregnancy or women of childbearing age without adequate contraception
- Women who are breast-feeding
- Hypothalamic cause of obesity, Cushing syndrome
- Major psychiatric disease including diagnosed eating disorders, history of drug or alcohol abuse
- History of bariatric surgery or complex abdominal surgery
- Inflammatory bowel disease
- Pancreatitis
- Cholelithiasis
- Uncontrolled gastroesophageal reflux
- Known upper GI bleeding conditions, e.g. gastric or esophageal varices
- Congenital or acquired abnormalities of the upper GI tract, e.g. stenosis
- Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- Chronic non-steroidal anti-inflammatory drug (NSAID) or aspirin treatment (Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period)
- Previous GI surgery that could affect the ability to place the device or the function of the implant
- GLP-1 receptor agonist therapy
- Known ischaemic heart disease or heart failure
- History of stroke
- Active Helicobacter pylori (Note: Subjects may be enrolled if they had a prior history of Helicobacter Pylori and were successfully treated)
- Iron deficiency and/or iron deficiency anemia
- Subjects or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- Known malignancy or any other multimorbid patient condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol or would put the participant at an unjustified risk
Sites / Locations
- Dept. of Internal Medicine, Medical University of Graz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EndoBarrier
Arm Description
EndoBarrier will be implemented for 9 months.
Outcomes
Primary Outcome Measures
Changes in insulin sensitivity
hyperinsulinaemic-euglycaemic clamp
Secondary Outcome Measures
Changes in Glucagon like peptide -1 levels
Meal Tolerance Test
Changes in gut permeability
Lactulose/Mannitol Test
Weight loss
Dual-energy X-ray absorptiometry
Changes in cardiovascular risks
United Kingdom Prospective Diabetes Study risk engine
Changes in gut microbiota
16S rDNA based microbial community profiling by next-generation sequencing
Changes in beta-cell function
intravenous glucose tolerance test
Full Information
NCT ID
NCT02769728
First Posted
May 3, 2016
Last Updated
February 18, 2019
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT02769728
Brief Title
EndoBarrier in Obese Subjects With Type 2 Diabetes Mellitus
Official Title
EndoBarrierTM in Obese Subjects With Type 2 Diabetes: Impact on Pancreatic Function, Insulin Resistance, Gut Peptides and Gut Permeability - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to explore short and longer-term effects of the Endobarrier™ implantation on insulin resistance and beta-cell function assessed by repeated Botnia clamps. In addition changes in gut peptides and gut permeability after implantation of a removable duodeno-jejunal bypass device to induce diabetes remission in obese subjects with sub-optimally controlled type 2 diabetes mellitus will be determined. Further changes in body weight and body composition, the change in global cardiovascular risk from baseline to 12 months, estimated using the UKPDS risk engine will be recorded.
Detailed Description
Obesity and diabetes probably represent the most challenging threat to public health in the 21st century. Obesity has multiple deleterious effects on health, significantly increasing the risk of fatal and non-fatal diseases including type 2 diabetes (T2DM). Bariatric surgery is a well-established method for the treatment of morbid obesity and has increasingly been recognized as an effective, long-lasting treatment option for T2DM.
Recently a potential, non-invasive alternative to bariatric surgery, a duodenal-jejunal bypass liner (EndoBarrierTM) has been introduced. It is an endoscopically implantable and removable device that prevents contact between partially digested nutrients and the proximal intestine. This device was shown to reduce body weight and to improve glycaemic control in subjects with diabetes. Small pilot studies suggested a change in incretin levels, similar to that observed after gastric surgery with an improvement of insulin sensitivity and glucose metabolism. To better understand and characterize the hormonal and/or metabolic effects after the implantation and removal of the EndoBarrierTM, this monocentric, prospective, trial is being performed.
The primary objective of this study is to clarify the changes in gut peptides and gut permeability after implantation the EndoBarrierTM in obese subjects with sub-optimally controlled type 2 diabetes mellitus. Additionally, the investigators aim to determine the changes in body weight and measure of adiposity, the change in global cardiovascular risk from baseline to 12 months as well as the changes in insulin sensitivity and beta-cell function over time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EndoBarrier
Arm Type
Experimental
Arm Description
EndoBarrier will be implemented for 9 months.
Intervention Type
Device
Intervention Name(s)
EndoBarrier
Other Intervention Name(s)
duodeno-jejunal bypass liner
Intervention Description
implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus
Primary Outcome Measure Information:
Title
Changes in insulin sensitivity
Description
hyperinsulinaemic-euglycaemic clamp
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Changes in Glucagon like peptide -1 levels
Description
Meal Tolerance Test
Time Frame
9 months
Title
Changes in gut permeability
Description
Lactulose/Mannitol Test
Time Frame
9 months
Title
Weight loss
Description
Dual-energy X-ray absorptiometry
Time Frame
9 months
Title
Changes in cardiovascular risks
Description
United Kingdom Prospective Diabetes Study risk engine
Time Frame
9 months
Title
Changes in gut microbiota
Description
16S rDNA based microbial community profiling by next-generation sequencing
Time Frame
9 months
Title
Changes in beta-cell function
Description
intravenous glucose tolerance test
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant is willing and able to give informed consent for participation in the study.
Type 2 diabetes
BMI 30-49 kg/m²
HbA1c ≥ 6.5% (48 mmol/mol)
Appropriate life style intervention measures have been tried but have failed to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months
Person is generally fit for intervention
Person commits to the need for long-term follow-up
Exclusion Criteria:
Type 1 diabetes mellitus
Maturity Onset Diabetes of the Young (MODY)
Secondary diabetes due to a specific disease or glucocorticoid therapy
Pregnancy or women of childbearing age without adequate contraception
Women who are breast-feeding
Hypothalamic cause of obesity, Cushing syndrome
Major psychiatric disease including diagnosed eating disorders, history of drug or alcohol abuse
History of bariatric surgery or complex abdominal surgery
Inflammatory bowel disease
Pancreatitis
Cholelithiasis
Uncontrolled gastroesophageal reflux
Known upper GI bleeding conditions, e.g. gastric or esophageal varices
Congenital or acquired abnormalities of the upper GI tract, e.g. stenosis
Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
Chronic non-steroidal anti-inflammatory drug (NSAID) or aspirin treatment (Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period)
Previous GI surgery that could affect the ability to place the device or the function of the implant
GLP-1 receptor agonist therapy
Known ischaemic heart disease or heart failure
History of stroke
Active Helicobacter pylori (Note: Subjects may be enrolled if they had a prior history of Helicobacter Pylori and were successfully treated)
Iron deficiency and/or iron deficiency anemia
Subjects or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
Known malignancy or any other multimorbid patient condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol or would put the participant at an unjustified risk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald Sourij, MD
Organizational Affiliation
Medical University of Graz, Auenbruggerplatz 15
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Internal Medicine, Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30539524
Citation
Tripolt NJ, Aberer F, Url J, Hogenauer C, Schreiber F, Eherer A, Sourij C, Obermayer AM, Stadlbauer V, Svehlikova E, Brunner M, Kojzar H, Pferschy PN, Pieber TR, Sourij H. Impact of Duodeno-Jejunal Bypass Liner (EndoBarrierTM) Implantation on Insulin Sensitivity in Patients with Type 2 Diabetes Mellitus (T2DM): A Study Protocol for a Pilot Trial. Diabetes Ther. 2019 Feb;10(1):299-309. doi: 10.1007/s13300-018-0540-z. Epub 2018 Dec 11.
Results Reference
derived
Learn more about this trial
EndoBarrier in Obese Subjects With Type 2 Diabetes Mellitus
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