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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043445
• Other study ID #: GPR119
• Status: Completed
• Phase: N/A
• First received: December 2, 2009
• Last updated: October 8, 2014
• Start date: September 2009
• Est. completion date: April 2010

Study information

• Verified date: October 2014
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Dietary Supplement:
• GPR 119 agonist, 2-oleyl glycerol
Emulgation, 50 ml. containing 2g 2OG
• Oleic acid
Emulgation, 50 ml. containing 1.54g of oleic acid
• Vehicle
Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol

Locations

Country	Name	City	State
Denmark	Department of Clinical Physiology, Glostrup Hospital	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 year	No
Secondary	Glucose homeostasis, gall bladder contraction in response of the different meals administered to the subjects		1 year	No