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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360878
• Other study ID #: DJBS meal test
• Status: Completed
• Phase: N/A
• First received: January 28, 2015
• Last updated: August 8, 2017
• Start date: February 2013
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Device:
• EndoBarrier Gastrointestinal Liner
Implantation with the EndoBarrier

Locations

Country	Name	City	State
Denmark	Center for Diabetes Research, Gentofte Hospital, University of Copenhagen	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Filip Krag Knop	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in gut microbiota as measured by DNA sequencing from baseline		52 weeks
Other	Change in body composition from baseline 26 weeks after implantation		1
Other	Change in body composition from baseline 52 weeks after implantation		1
Other	Change in caloric intake as measured by ad libitum meal test 1 week after implantation		30 minutes
Other	Change in caloric intake as measured by ad libitum meal test 26 weeks after implantation		30 minutes
Other	Change in caloric intake as measured by ad libitum meal test 52 weeks after implantation		30 minutes
Other	Change in caloric intake as measured by ad libitum meal test 3 weeks after explantation		30 minutes
Primary	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
Primary	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
Primary	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
Primary	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	Change in basal metabolic rate from baseline 1 week after implantation		0, 50, 210 minutes
Secondary	Change in basal metabolic rate from baseline 26 weeks after implantation		0, 50, 210 minutes
Secondary	Change in basal metabolic rate from baseline 52 weeks after implantation		0, 50, 210 minutes
Secondary	Change in basal metabolic rate from baseline 3 weeks after explantation		0, 50, 210 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in gallbladder emptying from baseline 1 week after implantation		0, 20, 40, 60, 90, 120, 150, 180
Secondary	Change in gallbladder emptying from baseline 26 weeks after implantation		0, 20, 40, 60, 90, 120, 150, 180
Secondary	Change in gallbladder emptying from baseline 52 weeks after implantation		0, 20, 40, 60, 90, 120, 150, 180
Secondary	Change in gallbladder emptying from baseline 3 weeks after explantation		0, 20, 40, 60, 90, 120, 150, 180
Secondary	Change in satiety scores as measured by Visual Analogue Scales 1 week after implantation		0, 30, 60, 90, 120, 180, 240
Secondary	Change in satiety scores as measured by Visual Analogue Scales 26 weeks after implantation		0, 30, 60, 90, 120, 180, 240
Secondary	Change in satiety scores as measured by Visual Analogue Scales 52 weeks after implantation		0, 30, 60, 90, 120, 180, 240
Secondary	Change in satiety scores as measured by Visual Analogue Scales 3 weeks after explantation		0, 30, 60, 90, 120, 180, 240
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in postprandial glucagon secretion 1 week after implantation		-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Secondary	Change in postprandial glucagon secretion 26 weeks after implantation		-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Secondary	Change in postprandial glucagon secretion 52 weeks after implantation		-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Secondary	Change in postprandial glucagon secretion 3 weeks after explantation		-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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