Importance of Meal Fat Content and Gall Bladder Emptying for Postprandial GLP-1 Secretion in Type 2 Diabetes Patients

U

University Hospital, Gentofte, Copenhagen

Status

Completed

Conditions

Diabetes

Study type

Observational

Funder types

Other

Identifiers

NCT01374594
GAL-INK II

Details and patient eligibility

About

PURPOSE The goal of the present project is to unravel the importance of bile acid-induced GLP-1 secretion (via the G protein-coupled receptor TGR5) in human physiology. In the present study the investigators examine the GLP-1 secretion in healthy subjects and in Type 2 Diabetes Mellitus (T2DM) patients. The investigators hypothesize that patients with T2DM of relatively long duration will be characterized by reduced gall bladder emptying, and, consequently, reduced intestinal TGR5 activation; resulting in attenuated postprandial GLP-1 responses (primary endpoint).

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: (Healthy)

  • HbA1 < 6 %
  • Normal haemoglobin levels
  • Informed content

Inclusion Criteria: (T2DM)

  • T2DM > 5 years
  • Normal haemoglobin levels
  • Informed content

Exclusion Criteria: (T2DM)

  • Treatment with insulin, DPP-IV inhibitor or GLP-1 analogues
  • Obesity (BMI > 30)
  • Age > 70 years
  • Gastrointestinal disease
  • Nephropathy
  • Liver disease
  • Medication which cannot be on hold for 12h
  • Gastrointestinal surgery

Exclusion Criteria: (Healthy)

  • 1st degree relatives with diabetes
  • Obesity (BMI > 30)
  • Age > 70 years
  • Gastrointestinal disease
  • Nephropathy
  • Liver disease
  • Medication which cannot be on hold for 12h
  • Gastrointestinal surgery

Trial design

30 participants in 2 patient groups

Healthy adults
Type 2 diabetes

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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