- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01043445
-Oleoyl Glycerol is a GPR119 Agonist and Signals GLP-1 Release in Humans.
October 8, 2014 updated by: Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen
G Protein-coupled Receptor in the Intestine (GPR 119) Stimulated GLP-1 Secretion
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Glostrup, Denmark, 2600
- Department of clinical physiology, Glostrup Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: GPR119 agonist, 2-oleoyl glycerol
2-oleoyl glycerol; 2g. and vehicle
|
Emulgation, 50 ml.
containing 2g 2OG
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
|
Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol
Emulgation, 50 ml.
containing 1.54g of oleic acid
|
PLACEBO_COMPARATOR: Vehicle
5 ml. of glycerol and 5 ml 96% ethanol
|
Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glucose homeostasis, gall bladder contraction in response of the different meals administered to the subjects
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (ACTUAL)
March 1, 2010
Study Completion (ACTUAL)
April 1, 2010
Study Registration Dates
First Submitted
December 2, 2009
First Submitted That Met QC Criteria
January 5, 2010
First Posted (ESTIMATE)
January 6, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
October 9, 2014
Last Update Submitted That Met QC Criteria
October 8, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GPR119
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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