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Diet Oil Induced Stimulation of GLP-1

This study is currently recruiting participants.
Verified October 2011 by University of Copenhagen
Sponsor:
Information provided by (Responsible Party):
Katrine Bagge Hansen, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01453842
First received: October 13, 2011
Last updated: October 17, 2011
Last verified: October 2011
History of Changes
  Purpose

Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1 (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals containing of olive oil or carbohydrates alone.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Dietary Supplement: Diet oil
Dietary Supplement: Olive oil
Dietary Supplement: Carrot
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Diet Oil Induced Stimulation of GLP-1

Resource links provided by NLM:

Drug Information available for: Olive oil
U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Plasma GLP-1 [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Glp-1 response is measured during and three hours after ingestion of the different mealtest


Secondary Outcome Measures:
  • Plasma insulin [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Plasma insulin is measured during and 3 hours after mealtest

  • Plasma glucose [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Plasma glucose is measured during and 3 hours after meal test

  • Plasma GIP [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Plasma GIP is measured during and 3 hours after meal test

  • Plasma glucagon [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Plasma glucagon is measured during and 3 hours after meal test

  • Plasma PYY [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Plasma PYY is measured during and 3 hours after meal test

  • Plasma paracetamol [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Plasma paracetamol is measured during and 3 hours after meal test


Estimated Enrollment: 12
Study Start Date: March 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet oil Dietary Supplement: Diet oil
Carrot and diet oil (containing 2-OG) and 1½ g of paracetamol
Active Comparator: Olive oil Dietary Supplement: Olive oil
Carrot and olive oil and 1½ g of paracetamol
Placebo Comparator: Carrot Dietary Supplement: Carrot
Carrot and 1½ g of paracetamol

Detailed Description:

Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1 (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals containing of olive oil or carbohydrates alone. The aim of the study is to elucidate the effect of 2-OG, 'diet oil' on GLP-1 secretion in patients with type 2 diabetes and to explain the mechanism behind the known stimulation of GLP-1 release by dietary fat.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus according to the WHO criteria
  • caucasians
  • age above 18 years
  • BMI 20-30

Exclusion Criteria:

  • kidney disease
  • liver disease
  • retinopathy
  • anaemia
  • use of insulin
  • use of GLP-1 analogues
  • use of DPP-4 inhibitors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453842

Contacts
Contact: Mette Johansen Mandøe, Student +45 27345030 mettemandoee@hotmail.com]
Contact: Katrine B Hansen, MD kbaggehansen@dadlnet.dk

Locations
Denmark
Department of Clinical Physiology Recruiting
Glostrup, Denmark, 2600
Contact: Mette Johansen-Mandøe, Student            
Sponsors and Collaborators
University of Copenhagen
Investigators
Study Chair: Katrine B Hansen, MD University of openhagen
Study Chair: Jens J Holst, Professor University of Copenhagen
Study Chair: Harald S Hansen, Professor University of Copenhagen
  More Information

No publications provided

Responsible Party: Katrine Bagge Hansen, MD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01453842     History of Changes
Other Study ID Numbers: Diet oil
Study First Received: October 13, 2011
Last Updated: October 17, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: National Board of Health

Keywords provided by University of Copenhagen:
Glucagon-like peptide-1
Glucose-dependant insulinotropic polypeptide
Glucagon
Peptide PYY
2-oleyl glycerol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastric Inhibitory Polypeptide
Incretins
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013