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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251510
• Other study ID #: GAL-INK I
• Status: Completed
• Phase: N/A
• First received: December 1, 2010
• Last updated: January 22, 2013
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2013
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
Denmark	Gentofte University Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GLP-1 secretion		Postprandial	No