ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01043445
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : October 9, 2014
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: GPR 119 agonist, 2-oleyl glycerol Dietary Supplement: Oleic acid Dietary Supplement: Vehicle Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: G Protein-coupled Receptor in the Intestine (GPR 119) Stimulated GLP-1 Secretion
Study Start Date : September 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: GPR119 agonist, 2-oleoyl glycerol
2-oleoyl glycerol; 2g. and vehicle
 Dietary Supplement: GPR 119 agonist, 2-oleyl glycerol
Emulgation, 50 ml. containing 2g 2OG

Dietary Supplement: Vehicle
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
 Dietary Supplement: Oleic acid
Emulgation, 50 ml. containing 1.54g of oleic acid

Dietary Supplement: Vehicle
Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol
Placebo Comparator: Vehicle
5 ml. of glycerol and 5 ml 96% ethanol
 Dietary Supplement: Vehicle
Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Glucose homeostasis, gall bladder contraction in response of the different meals administered to the subjects [ Time Frame: 1 year ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043445


Locations
Denmark
Department of Clinical Physiology, Glostrup Hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
University of Copenhagen
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Katrine Bagge Hansen, MD, Ph.d, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01043445     History of Changes
Other Study ID Numbers: GPR119
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: October 9, 2014
Last Verified: October 2014

Keywords provided by Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen:
GPR 119
GLP-1 secretion
2-oleoyl-glycerol
Dietary supplementation

Additional relevant MeSH terms:
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs