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

This study has been completed.

Sponsor:

Collaborator:

University of Copenhagen

Information provided by (Responsible Party):

Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen

ClinicalTrials.gov Identifier:

NCT01043445

First received: December 2, 2009

Last updated: October 8, 2014

Last verified: October 2014

History of Changes

Purpose

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	Intervention
Type 2 Diabetes	Dietary Supplement: GPR 119 agonist, 2-oleyl glycerol Dietary Supplement: Oleic acid Dietary Supplement: Vehicle


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
Official Title:	G Protein-coupled Receptor in the Intestine (GPR 119) Stimulated GLP-1 Secretion

Resource links provided by NLM:

Drug Information available for: Glycerin

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Glucose homeostasis, gall bladder contraction in response of the different meals administered to the subjects [ Time Frame: 1 year ] [ Designated as safety issue: No ]


Enrollment:	8
Study Start Date:	September 2009
Study Completion Date:	April 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 30 Years
Genders 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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


Responsible Party:	Katrine Bagge Hansen, MD, Ph.d, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:	NCT01043445 History of Changes
Other Study ID Numbers:	GPR119
Study First Received:	December 2, 2009
Last Updated:	October 8, 2014
Health Authority:	Denmark: National Board of Health Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency

Keywords provided by Glostrup University Hospital, Copenhagen:


GPR 119 GLP-1 secretion 2-oleoyl-glycerol Dietary supplementation

Additional relevant MeSH terms:


Glycerol Cryoprotective Agents Pharmacologic Actions Physiological Effects of Drugs Protective Agents

ClinicalTrials.gov processed this record on March 03, 2015

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