The Role of Metformin and Colesevelam in Human GLP-1 Secretion (ColMetInc)

October 6, 2014 updated by: Morten Hansen, University Hospital, Gentofte, Copenhagen
Our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (GLP-1).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Hellerup, Copenhagen, Denmark, 2900
        • Diabetes Research Division, Department of Medicine, Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal hemoglobin
  • BMI > 23kg/m2
  • HbA1c <9 %
  • Informed concent

Exclusion Criteria:

  • Liver disease ( aspartate aminotransferase/alanine aminotransferase >2 × reference value)
  • Chronic intestinal disease
  • History of liver and / or gallbladder disease
  • Nephropathy (se-creatinine >110 µM and / or albuminuria)
  • Insulin or GLP-1-based antidiabetic treatment
  • History of cholecystectomy or surgical resection of bowel segment
  • BMI <23kg/m2 or BMI >35 kg/m2
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
Other: Placebo
Experimental: Metformin
Drug: Metformin
Experimental: Colesevelam
Drug: Colesevelam
Experimental: Colesevelam + exendin (9-39)
Drug: Colesevelam
Experimental: Metformin + exendin (9-39)
Drug: Metformin
Experimental: Placebo + + exendin (9-39)
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the gut hormone glucagon-like peptide 1 (GLP-1)
Time Frame: 0-240 min
0-240 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Estimate)

October 7, 2014

Last Update Submitted That Met QC Criteria

October 6, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2013-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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