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

F

Filip Krag Knop

Status

Completed

Conditions

Obesity
Type 2 Diabetes

Treatments

Device: EndoBarrier Gastrointestinal Liner

Study type

Observational

Funder types

Other

Identifiers

NCT02360878
DJBS meal test

Details and patient eligibility

About

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

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

25 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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