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

Study Description

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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

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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

Arms and Interventions

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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

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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

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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

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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

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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
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