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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David P. Sonne, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01251510
First received: December 1, 2010
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 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 University Hospital, Gentofte, Copenhagen:

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

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

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 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
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: 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

No publications provided by University Hospital, Gentofte, Copenhagen

Additional 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
Study First Received: December 1, 2010
Last Updated: January 22, 2013
Health Authority: Denmark: Danish Dataprotection Agency

ClinicalTrials.gov processed this record on September 22, 2014