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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02360878

Enrollment

Registered

2015-02-11

Start date

2013-02-28

Completion date

2017-07-31

Last updated

2017-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Type 2 Diabetes

Keywords

DJBS, Duodenal-jejunal bypass sleeve, Duodenal-jejunal bypass liner, Endobarrier, Obesity, Type 2 diabetes, Incretin hormones, Postprandial glucose metabolism

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.

Interventions

DEVICEEndoBarrier Gastrointestinal Liner

Implantation with the EndoBarrier

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	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

Measure	Time frame
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 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 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 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 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

Other

Measure	Time frame
Change in caloric intake as measured by ad libitum meal test 3 weeks after explantation	30 minutes
Change in gut microbiota as measured by DNA sequencing from baseline	52 weeks
Change in body composition from baseline 26 weeks after implantation	1
Change in body composition from baseline 52 weeks after implantation	1
Change in caloric intake as measured by ad libitum meal test 1 week after implantation	30 minutes
Change in caloric intake as measured by ad libitum meal test 26 weeks after implantation	30 minutes
Change in caloric intake as measured by ad libitum meal test 52 weeks after implantation	30 minutes

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026