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Completed

NCT Number: NCT01043445

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Physiology, Glostrup Hospital

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GPR 119 agonist, 2-oleyl glycerol

Dietary Supplement

Emulgation, 50 ml. containing 2g 2OG

Oleic acid

Dietary Supplement

Emulgation, 50 ml. containing 1.54g of oleic acid

Vehicle

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Glucose homeostasis, gall bladder contraction in response of the different meals administered to the subjects

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 6, 2010
Registry last updated
Oct 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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