-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
  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:


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:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glycerol
Cryoprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 23, 2014