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

Filip Krag Knop25 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 2 Diabetes Obesity

Interventions

EndoBarrier Gastrointestinal LinerDEVICE

Implantation with the EndoBarrier

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Hellerup, Denmark

Outcomes

Primary Outcomes

Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 1 week after implantation

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

Secondary Outcomes

Change in basal metabolic rate from baseline 1 week after implantation

Time frame: 0, 50, 210 minutes

Change in basal metabolic rate from baseline 26 weeks after implantation

Time frame: 0, 50, 210 minutes

Change in basal metabolic rate from baseline 52 weeks after implantation

Time frame: 0, 50, 210 minutes

Change in basal metabolic rate from baseline 3 weeks after explantation

Time frame: 0, 50, 210 minutes

Change in gastric emptying from baseline 1 week after implantation

Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

Data from ClinicalTrials.gov

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Change in gastric emptying from baseline 26 weeks after implantation

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: 0, 20, 40, 60, 90, 120, 150, 180

Change in gallbladder emptying from baseline 26 weeks after implantation

Time frame: 0, 20, 40, 60, 90, 120, 150, 180

Change in gallbladder emptying from baseline 52 weeks after implantation

Time frame: 0, 20, 40, 60, 90, 120, 150, 180

Change in gallbladder emptying from baseline 3 weeks after explantation

Time frame: 0, 20, 40, 60, 90, 120, 150, 180

Change in satiety scores as measured by Visual Analogue Scales 1 week after implantation

Time frame: 0, 30, 60, 90, 120, 180, 240

Change in satiety scores as measured by Visual Analogue Scales 26 weeks after implantation

Time frame: 0, 30, 60, 90, 120, 180, 240

Change in satiety scores as measured by Visual Analogue Scales 52 weeks after implantation

Time frame: 0, 30, 60, 90, 120, 180, 240

Change in satiety scores as measured by Visual Analogue Scales 3 weeks after explantation

Time frame: 0, 30, 60, 90, 120, 180, 240

Change in postprandial insulin secretion from baseline 1 week after implantation

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

Change in postprandial glucagon secretion 1 week after implantation

Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

Change in postprandial glucagon secretion 26 weeks after implantation

Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

Change in postprandial glucagon secretion 52 weeks after implantation

Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

Change in postprandial glucagon secretion 3 weeks after explantation

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -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

Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes