-Oleoyl Glycerol is a GPR119 Agonist and Signals GLP-1 Release in Humans.

October 8, 2014 updated by: Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen

G Protein-coupled Receptor in the Intestine (GPR 119) Stimulated GLP-1 Secretion

The purpose of this study is to evaluate the impact of different ligands of GPR 119 (a G protein-coupled receptor in the intestine) on the secretion of the incretin hormones, GLP-1 and GIP.

Study Overview

Detailed Description

We have found a new ligand for the GPR 119 receptor. This study evaluate the impact of this ligand on the incretion hormone responses, beta cell function and gall bladder function in healthy young men.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

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

      • Glostrup, Denmark, 2600
        • Department of clinical physiology, Glostrup 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 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy caucasians v- Normal OGTT (75 g of glucose) according to WHO's criteria
  • Normal hemoglobin
  • Informed consent

Exclusion Criteria:

  • Liver disease (ALAT> 2x normal level)
  • Nephropathy (s-creatinin >130 microM or albuminuria)
  • Relatives with type 2 diabetes

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GPR119 agonist, 2-oleoyl glycerol
2-oleoyl glycerol; 2g. and vehicle
Emulgation, 50 ml. containing 2g 2OG
Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol
ACTIVE_COMPARATOR: Oleic acid
oleic acid; 3.2g and vehicle
Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol
Emulgation, 50 ml. containing 1.54g of oleic acid
PLACEBO_COMPARATOR: Vehicle
5 ml. of glycerol and 5 ml 96% ethanol
Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect of this newly discovered GPR 119 agonist on gut hormone responses, in particular GLP-1 in response of the different meals administered to the subjects
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Glucose homeostasis, gall bladder contraction in response of the different meals administered to the subjects
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Katrine B Hansen, MD, Glostrup Hospital, University of Copenhagen
  • Study Director: Filip K Knop, MD, Ph.d, Gentofte Hospital
  • Study Director: Harald S Hansen, professor, Farmaceutical Faculty, University of Copenhagen
  • Study Director: Jens J Holst, MD;DMSc, Biomedical Science, University of Copenhagen

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

September 1, 2009

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

January 5, 2010

First Posted (ESTIMATE)

January 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 9, 2014

Last Update Submitted That Met QC Criteria

October 8, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

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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