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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David P. Sonne, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01374594
First received: June 14, 2011
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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).


Condition
Diabetes

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • GLP-1 secretion [ Time Frame: Postprandial ] [ Designated as safety issue: No ]

Biospecimen Description:

blood samples


Enrollment: 30
Study Start Date: June 2011
Study Completion Date: November 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy adults
Type 2 diabetes

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy subjects and type 2 diabetes patients (T2DM)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374594

Locations
Denmark
Gentofte University Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
  More Information

No publications provided

Responsible Party: David P. Sonne, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01374594     History of Changes
Other Study ID Numbers: GAL-INK II
Study First Received: June 14, 2011
Last Updated: January 22, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014