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Diet Oil Induced Stimulation of GLP-1

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ClinicalTrials.gov Identifier: NCT01453842
Recruitment Status : Completed
First Posted : October 18, 2011
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Diet oil Dietary Supplement: Olive oil Dietary Supplement: Carrot Early Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Diet Oil Induced Stimulation of GLP-1
Study Start Date : March 2011
Primary Completion Date : December 2011
Study Completion Date : March 2012

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Plasma GLP-1 [ Time Frame: 3 hours ]
    Glp-1 response is measured during and three hours after ingestion of the different mealtest


Secondary Outcome Measures :
  1. Plasma insulin [ Time Frame: 3 hours ]
    Plasma insulin is measured during and 3 hours after mealtest

  2. Plasma glucose [ Time Frame: 3 hours ]
    Plasma glucose is measured during and 3 hours after meal test

  3. Plasma GIP [ Time Frame: 3 hours ]
    Plasma GIP is measured during and 3 hours after meal test

  4. Plasma glucagon [ Time Frame: 3 hours ]
    Plasma glucagon is measured during and 3 hours after meal test

  5. Plasma PYY [ Time Frame: 3 hours ]
    Plasma PYY is measured during and 3 hours after meal test

  6. Plasma paracetamol [ Time Frame: 3 hours ]
    Plasma paracetamol is measured during and 3 hours after meal test


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453842


Locations
Denmark
Department of Clinical Physiology
Glostrup, Denmark, 2600
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

Responsible Party: Katrine Bagge Hansen, MD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01453842     History of Changes
Other Study ID Numbers: Diet oil
First Posted: October 18, 2011    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Katrine Bagge Hansen, 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
Glucagon
Gastric Inhibitory Polypeptide
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins