GPR 119 Stimulated GLP-1 Secretion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01043445
First received: December 2, 2009
Last updated: January 5, 2010
Last verified: January 2010
  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
Endogenous GLP-1 Secretion
Dietary Supplement: A lipid shown to act specifically by the GPR 119 receptor
Dietary Supplement: Active comparator

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 ]

Estimated Enrollment: 6
Study Start Date: September 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GPR119 agonist Dietary Supplement: A lipid shown to act specifically by the GPR 119 receptor
Emulgation of the lipid 50 ml. is compared to emulgation of oleic acid50 ml.
Other Name: GPR 119 agonist, lipids, oleic acid
Placebo Comparator: Oleic acid Dietary Supplement: A lipid shown to act specifically by the GPR 119 receptor
Emulgation of the lipid 50 ml. is compared to emulgation of oleic acid50 ml.
Other Name: GPR 119 agonist, lipids, oleic acid
Active Comparator: GPR 119 agonist and oral glucose Dietary Supplement: Active comparator
Emulgation of the lipid 50 ml.combined with 10 g of glucose is compared to emulgation of oleic acid 50 ml.combined with 10 g of glucose.
Other Name: GPR 119 agonist, lipids, oleic acid
Placebo Comparator: Oleic acid and oral glucose Dietary Supplement: Active comparator
Emulgation of the lipid 50 ml.combined with 10 g of glucose is compared to emulgation of oleic acid 50 ml.combined with 10 g of glucose.
Other Name: GPR 119 agonist, lipids, oleic acid

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

Contacts
Contact: Katrine B Hansen, MD +4540509942 kbaggehansen@dadlnet.dk
Contact: Jens J Holst, MD;DMSc holst@mfi.ku.dk

Locations
Denmark
Department of Clinical Physiology, Glostrup Hospital Recruiting
Glostrup, Denmark, 2600
Contact: Katrine B Hansen, MD    +4540509942    kbaggehansen@dadlnet.dk   
Principal Investigator: Katrine B Hansen, MD         
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, Glostrup Hospital and University of Copenhagen
ClinicalTrials.gov Identifier: NCT01043445     History of Changes
Other Study ID Numbers: GPR119
Study First Received: December 2, 2009
Last Updated: January 5, 2010
Health Authority: Denmark: National Board of Health
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 18, 2014