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

Completed

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Device: EndoBarrier Gastrointestinal Liner

• Registration Number: NCT02360878
• Lead Sponsor: Filip Krag Knop

Brief Summary

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

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-11
• Primary Completion: 2017-06
• Study Completion: 2017-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T2DM subjects	EndoBarrier Gastrointestinal Liner	Obese (BMI \> 30 kg/m2) with type 2 diabetes implanted with the EndoBarrier Gastrointestinal liner
Non-diabetic subjects	EndoBarrier Gastrointestinal Liner	Obese (BMI \> 30 kg/m2) with normal glucose tolerance implanted with the EndoBarrier Gastrointestinal liner

Primary Outcome Measures

Name	Time	Method
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 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
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

Secondary Outcome Measures

Name	Time	Method
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 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 52 weeks after implantation	0, 20, 40, 60, 90, 120, 150, 180
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 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 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 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 3 weeks after explantation	-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 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 52 weeks after implantation	-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in satiety scores as measured by Visual Analogue Scales 52 weeks after implantation	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 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 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 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 26 weeks after implantation	-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in basal metabolic rate from baseline 52 weeks after implantation	0, 50, 210 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 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 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 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 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 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 26 weeks after implantation	-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
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 3 weeks after explantation	0, 30, 60, 90, 120, 180, 240
Change in basal metabolic rate from baseline 3 weeks after explantation	0, 50, 210 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 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 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 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 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 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 ghrelin from baseline 52 weeks after implantation	-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

Trial Locations

Locations (1)

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen; 🇩🇰 Hellerup, Denmark