Type 2 DiabetesNCT01043445
-Oleoyl Glycerol is a GPR119 Agonist and Signals GLP-1 Release in Humans.
A study testing GPR 119 agonist, 2-oleyl glycerol and Oleic acid in people with Type 2 Diabetes, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- GPR 119 agonist, 2-oleyl glycerol and Oleic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy caucasians v- Normal OGTT (75 g of glucose) according to WHO's criteria
- Normal hemoglobin
- Informed consent
Who cannot join
- Liver disease (ALAT> 2x normal level)
- Nephropathy (s-creatinin >130 microM or albuminuria)
- Relatives with type 2 diabetes
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Physiology, Glostrup Hospital
Glostrup Municipality, 2600
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- GPR 119 agonist, 2-oleyl glycerol, Oleic acid, Vehicle
- Keywords
- GPR 119, GLP-1 secretion, 2-oleoyl-glycerol, Dietary supplementation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPR 119 agonist, 2-oleyl glycerolDietary supplement
Emulgation, 50 ml. containing 2g 2OG
Oleic acidDietary supplement
Emulgation, 50 ml. containing 1.54g of oleic acid
VehicleDietary supplement
Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol
| Study group | Role | What they receive |
|---|---|---|
| GPR119 agonist, 2-oleoyl glycerol | Experimental | 2-oleoyl glycerol; 2g. and vehicle Receives: Dietary Supplement: GPR 119 agonist, 2-oleyl glycerol; Dietary Supplement: Vehicle |
| Oleic acid | Active comparator | oleic acid; 3.2g and vehicle Receives: Dietary Supplement: Oleic acid; Dietary Supplement: Vehicle |
| Vehicle | Placebo comparator | 5 ml. of glycerol and 5 ml 96% ethanol Receives: Dietary Supplement: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
Glucose homeostasis, gall bladder contraction in response of the different meals administered to the subjects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen
- Investigators
- Katrine B Hansen, MD, Principal investigator, Glostrup Hospital, University of CopenhagenFilip K Knop, MD, Ph.d, Study director, Gentofte HospitalHarald S Hansen, professor, Study director, Farmaceutical Faculty, University of CopenhagenJens J Holst, MD;DMSc, Study director, Biomedical Science, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043445
- Sponsor's protocol ID
- GPR119
- Status last verified
- Oct 2014
- First submitted
- 2 Dec 2009
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G Protein-coupled Receptor in the Intestine (GPR 119) Stimulated GLP-1 Secretion
- ClinicalTrials.gov ID
- NCT01043445
- Acronym / sponsor ID
- GPR119
- Conditions
- Type 2 Diabetes
- Keywords
- GPR 119, GLP-1 secretion, 2-oleoyl-glycerol, Dietary supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GPR119 agonist, 2-oleoyl glycerol | Experimental | Dietary Supplement: GPR 119 agonist, 2-oleyl glycerol, Dietary Supplement: Vehicle2-oleoyl glycerol; 2g. and vehicle |
| Oleic acid | Active comparator | Dietary Supplement: Oleic acid, Dietary Supplement: Vehicleoleic acid; 3.2g and vehicle |
| Vehicle | Placebo comparator | Dietary Supplement: Vehicle5 ml. of glycerol and 5 ml 96% ethanol |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy caucasians v- Normal OGTT (75 g of glucose) according to WHO's criteria
- Normal hemoglobin
- Informed consent
Key exclusion criteria (3 listed)
- Liver disease (ALAT> 2x normal level)
- Nephropathy (s-creatinin >130 microM or albuminuria)
- Relatives with type 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPR 119 agonist, 2-oleyl glycerolEmulgation, 50 ml. containing 2g 2OG | Dietary supplement | GPR119 agonist, 2-oleoyl glycerol |
| Oleic acidEmulgation, 50 ml. containing 1.54g of oleic acid | Dietary supplement | Oleic acid |
| VehicleFifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol | Dietary supplement | GPR119 agonist, 2-oleoyl glycerol, Oleic acid, Vehicle |
Primary outcome
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 secondary outcome
Glucose homeostasis, gall bladder contraction in response of the different meals administered to the subjects
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrine B Hansen, MD principal investigator
Glostrup Hospital, University of Copenhagen
Filip K Knop, MD, Ph.d study director
Gentofte Hospital
Harald S Hansen, professor study director
Farmaceutical Faculty, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GPR 119 agonist, 2-oleyl glycerol and Oleic acid in people with Type 2 Diabetes, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.