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

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ClinicalTrials.gov Identifier: NCT01374594
Recruitment Status : Completed
First Posted : June 16, 2011
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
David P. Sonne, University Hospital, Gentofte, Copenhagen

Study Description
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Brief Summary:

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 or disease
Diabetes

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Study Start Date : June 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : November 2012

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Groups and Cohorts
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Group/Cohort
Healthy adults
Type 2 diabetes


Outcome Measures
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Primary Outcome Measures :
  1. GLP-1 secretion [ Time Frame: Postprandial ]

Biospecimen Description:
blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374594


Locations
Denmark
Gentofte University Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David P. Sonne, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01374594     History of Changes
Other Study ID Numbers: GAL-INK II
First Posted: June 16, 2011    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013