The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones

Study Overview
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Brief Summary
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We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose metabolism as well as gut and pancreatic hormone secretion.

Detailed Description
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Duodenal-jejunal bypass sleeve (DJBS) is being developed for the treatment of obesity, and initial clinical outcomes suggest that this minimally invasive endoscopic technique potentially has beneficial effects on type 2 diabetes also. However, the mechanisms behind the antidiabetic effects of the procedure remain unknown. We want to elucidate how the DJBS might change postprandial secretion of gut and pancreatic hormones.

Official Title
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The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones

Conditions
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Type 2 Diabetes, Obesity

Intervention / Treatment
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* Device: EndoBarrier Gastrointestinal Liner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (obese subjects with type 2 diabetes): treatment with DJBS written informed consent antidiabetic monotherapy/or diet > 18 years old not anemic Exclusion Criteria (obese subjects with type 2 diabetes): antidiabetic treatment with insulin, GLP-1-agonists, DPP4-inhibitors or more than one orally administered antidiabetic drug. anemia Inclusion Criteria (obese subjects without type 2 diabetes): Treatment with DJBS written informed consent not anemic HbA1c < 6,0% or HbA1c < 6,5% and normal glucose tolerance test and normal fasting plasma glucose (< 6,0 mM) Exclusion Criteria (obese subjects without type 2 diabetes): HbA1c > 6,5 % and/or a non-normal glucose tolerance test and/or fasting plasma glucose > 6,0 mM

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-diabetic subjects<br>Obese (BMI > 30 kg/m2) with normal glucose tolerance implanted with the EndoBarrier Gastrointestinal liner | Device: EndoBarrier Gastrointestinal Liner<br>* Implantation with the EndoBarrier<br>* Other names: DJBS;|
| T2DM subjects<br>Obese (BMI > 30 kg/m2) with type 2 diabetes implanted with the EndoBarrier Gastrointestinal liner | Device: EndoBarrier Gastrointestinal Liner<br>* Implantation with the EndoBarrier<br>* Other names: DJBS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 1 week after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 26 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 52 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 3 weeks after explantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in basal metabolic rate from baseline 1 week after implantation |  | 0, 50, 210 minutes | 
| Change in basal metabolic rate from baseline 26 weeks after implantation |  | 0, 50, 210 minutes | 
| Change in basal metabolic rate from baseline 52 weeks after implantation |  | 0, 50, 210 minutes | 
| Change in basal metabolic rate from baseline 3 weeks after explantation |  | 0, 50, 210 minutes | 
| Change in gastric emptying from baseline 1 week after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in gastric emptying from baseline 26 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in gastric emptying from baseline 52 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in gastric emptying from baseline 3 weeks after explantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in gallbladder emptying from baseline 1 week after implantation |  | 0, 20, 40, 60, 90, 120, 150, 180 | 
| Change in gallbladder emptying from baseline 26 weeks after implantation |  | 0, 20, 40, 60, 90, 120, 150, 180 | 
| Change in gallbladder emptying from baseline 52 weeks after implantation |  | 0, 20, 40, 60, 90, 120, 150, 180 | 
| Change in gallbladder emptying from baseline 3 weeks after explantation |  | 0, 20, 40, 60, 90, 120, 150, 180 | 
| Change in satiety scores as measured by Visual Analogue Scales 1 week after implantation |  | 0, 30, 60, 90, 120, 180, 240 | 
| Change in satiety scores as measured by Visual Analogue Scales 26 weeks after implantation |  | 0, 30, 60, 90, 120, 180, 240 | 
| Change in satiety scores as measured by Visual Analogue Scales 52 weeks after implantation |  | 0, 30, 60, 90, 120, 180, 240 | 
| Change in satiety scores as measured by Visual Analogue Scales 3 weeks after explantation |  | 0, 30, 60, 90, 120, 180, 240 | 
| Change in postprandial insulin secretion from baseline 1 week after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial insulin secretion from baseline 26 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial insulin secretion from baseline 52 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial insulin secretion from baseline 3 weeks after explantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucagon secretion 1 week after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucagon secretion 26 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucagon secretion 52 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucagon secretion 3 weeks after explantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucose from baseline 1 week after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucose from baseline 26 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucose from baseline 52 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucose form baseline 3 weeks after explantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial PYY from baseline 1 week after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial PYY from baseline 26 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial PYY from baseline 52 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial PYY from baseline 3 weeks after explantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial ghrelin from baseline 1 week after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial ghrelin from baseline 26 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial ghrelin from baseline 52 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial ghrelin from baseline 3 weeks after explantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 1 week after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 26 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 52 weeks after implantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 
| Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 3 weeks after explantation |  | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postprandial glucose metabolism, DJBS, Duodenal-jejunal bypass sleeve, Duodenal-jejunal bypass liner, Endobarrier, Obesity, Type 2 diabetes, Incretin hormones