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

August 8, 2017 updated by: Filip Krag Knop

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: EndoBarrier Gastrointestinal Liner

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Hellerup, Denmark, 2900
    - Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obese subjects with or without type 2 diabetes treated with the DJBS will be suitable for participating in the trial

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-diabetic subjects Obese (BMI > 30 kg/m2) with normal glucose tolerance implanted with the EndoBarrier Gastrointestinal liner	Device: EndoBarrier Gastrointestinal Liner Implantation with the EndoBarrier Other Names: DJBS
T2DM subjects Obese (BMI > 30 kg/m2) with type 2 diabetes implanted with the EndoBarrier Gastrointestinal liner	Device: EndoBarrier Gastrointestinal Liner Implantation with the EndoBarrier Other Names: DJBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	-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	-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	-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	-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

Secondary Outcome Measures

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Filip Krag Knop

Collaborators

University of Copenhagen

Investigators

Principal Investigator: Filip K Knop, MD, Ph.D., Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
Principal Investigator: Ulrich Rohde, MD, Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

DJBS meal test

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Outcome Measure	Time Frame
Change in basal metabolic rate from baseline 1 week after implantation Time Frame: 0, 50, 210 minutes	0, 50, 210 minutes
Change in basal metabolic rate from baseline 26 weeks after implantation Time Frame: 0, 50, 210 minutes	0, 50, 210 minutes
Change in basal metabolic rate from baseline 52 weeks after implantation Time Frame: 0, 50, 210 minutes	0, 50, 210 minutes
Change in basal metabolic rate from baseline 3 weeks after explantation Time Frame: 0, 50, 210 minutes	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	-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 Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes	-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	-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	-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	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	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	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	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	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	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	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	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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-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	-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Other Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Obesity

Clinical Trials on EndoBarrier Gastrointestinal Liner

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