NCT01251510

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

8 months

First QC Date

December 1, 2010

Last Update Submit

January 22, 2013

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • GLP-1 secretion

    Postprandial

Study Arms (2)

Healthy adults

Type 2 diabetes

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects and cholcystectomised patients (chol)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte University Hospital

Hellerup, 2900, Denmark

Location

Related Publications (1)

  • Sonne DP, Hare KJ, Martens P, Rehfeld JF, Holst JJ, Vilsboll T, Knop FK. Postprandial gut hormone responses and glucose metabolism in cholecystectomized patients. Am J Physiol Gastrointest Liver Physiol. 2013 Feb 15;304(4):G413-9. doi: 10.1152/ajpgi.00435.2012. Epub 2012 Dec 28.

    PMID: 23275610DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • David P. Sonne, MD

    Gentofte Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 2, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

DK(1)