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

NCT ID: NCT01043445

Last Updated: 2014-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-04-30

Brief Summary

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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

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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

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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GPR119 agonist, 2-oleoyl glycerol

2-oleoyl glycerol; 2g. and vehicle

Group Type EXPERIMENTAL

GPR 119 agonist, 2-oleyl glycerol

Intervention Type DIETARY_SUPPLEMENT

Emulgation, 50 ml. containing 2g 2OG

Vehicle

Intervention Type DIETARY_SUPPLEMENT

Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol

Oleic acid

oleic acid; 3.2g and vehicle

Group Type ACTIVE_COMPARATOR

Oleic acid

Intervention Type DIETARY_SUPPLEMENT

Emulgation, 50 ml. containing 1.54g of oleic acid

Vehicle

Intervention Type DIETARY_SUPPLEMENT

Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol

Vehicle

5 ml. of glycerol and 5 ml 96% ethanol

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DIETARY_SUPPLEMENT

Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol

Interventions

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GPR 119 agonist, 2-oleyl glycerol

Emulgation, 50 ml. containing 2g 2OG

Intervention Type DIETARY_SUPPLEMENT

Oleic acid

Emulgation, 50 ml. containing 1.54g of oleic acid

Intervention Type DIETARY_SUPPLEMENT

Vehicle

Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Katrine Bagge Hansen

MD, Ph.d

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katrine B Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Glostrup Hospital, University of Copenhagen

Filip K Knop, MD, Ph.d

Role: STUDY_DIRECTOR

Gentofte Hospital

Harald S Hansen, professor

Role: STUDY_DIRECTOR

Farmaceutical Faculty, University of Copenhagen

Jens J Holst, MD;DMSc

Role: STUDY_DIRECTOR

Biomedical Science, University of Copenhagen

Locations

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Department of Clinical Physiology, Glostrup Hospital

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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GPR119

Identifier Type: -

Identifier Source: org_study_id

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