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Bile Acid-induced GLP-secretion. A Study in Cholecystectomized Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01251510
First Posted: December 2, 2010
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David P. Sonne, University Hospital, Gentofte, Copenhagen
  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 cholecystectomised patients. Thereby the investigators aim to show, that cholecystectomised patients have reduced bileflow after a meal, and as a consequence exhibit a diminished GLP-1 response as compared to healthy subjects.


Condition
Diabetes

Study Type: Observational
Official Title: Bile Acid-induced GLP-secretion. A Study in Cholecystectomized Subjects

Further study details as provided by David P. Sonne, University Hospital, Gentofte, Copenhagen:

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

Biospecimen Retention:   Samples With DNA
blood samples

Enrollment: 20
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy adults
Type 2 diabetes

  Eligibility

Information from the National Library of Medicine

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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 cholcystectomised patients (chol)
Criteria

Inclusion Criteria: (Healthy)

  • Normal fasting plasma glucose
  • Normal glucose tolerance
  • Normal haemoglobin levels
  • Informed content

Inclusion Criteria: (cholecystectomy group)

  • Laparoscopic cholecystectomy <6 months. Indication: Gallstones.
  • Normal fasting plasma glucose
  • Normal glucose tolerance
  • Normal haemoglobin levels
  • Informed content

Exclusion Criteria: (both groups)

  • Diabetes
  • Pre diabetes (impaired glucose tolerance or impaired fasting glucose)
  • 1st degree relatives with diabetes
  • Obesity (BMI > 30)
  • Inflammatory bowels disease
  • Nephropathy
  • Liver disease
  • Medication which cannot be on hold for 24h
  Contacts and Locations
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): NCT01251510


Locations
Denmark
Gentofte University Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: David P. Sonne, MD Gentofte Hospital, University of Copenhagen
  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: NCT01251510     History of Changes
Other Study ID Numbers: GAL-INK I
First Submitted: December 1, 2010
First Posted: December 2, 2010
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Bile Acids and Salts
Gastrointestinal Agents