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

NCT ID: NCT02360878

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-07-31

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.

Conditions

Type 2 Diabetes; Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-diabetic subjects

Obese (BMI \> 30 kg/m2) with normal glucose tolerance implanted with the EndoBarrier Gastrointestinal liner

EndoBarrier Gastrointestinal Liner

Intervention Type: DEVICE

Implantation with the EndoBarrier

T2DM subjects

Obese (BMI \> 30 kg/m2) with type 2 diabetes implanted with the EndoBarrier Gastrointestinal liner

EndoBarrier Gastrointestinal Liner

Intervention Type: DEVICE

Implantation with the EndoBarrier

Interventions

EndoBarrier Gastrointestinal Liner

Implantation with the EndoBarrier

Intervention Type: DEVICE

Other Intervention Names

DJBS

Eligibility Criteria

Inclusion Criteria

• treatment with DJBS
• written informed consent
• antidiabetic monotherapy/or diet
• > 18 years old
• not anemic

• 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

• antidiabetic treatment with insulin, GLP-1-agonists, DPP4-inhibitors or more than one orally administered antidiabetic drug.
• anemia

• HbA1c > 6,5 % and/or a non-normal glucose tolerance test and/or fasting plasma glucose > 6,0 mM

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Filip Krag Knop

OTHER

Sponsor Role: lead

Responsible Party

Filip Krag Knop

MD, Ph.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Filip K Knop, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Ulrich Rohde, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Locations

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Hellerup, , Denmark

Countries

Denmark

Other Identifiers

DJBS meal test

Identifier Type: -

Identifier Source: org_study_id