Diet Oil Induced Stimulation of GLP-1

December 1, 2014 updated by: Katrine Bagge Hansen, University of Copenhagen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Department of Clinical Physiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Olive oil
Dietary supplement: Olive oil
Carrot and olive oil and 1½ g of paracetamol
Experimental: Diet oil
Dietary supplement: Diet oil
Carrot and diet oil (containing 2-OG) and 1½ g of paracetamol
Placebo Comparator: Carrot
Dietary supplement: Carrot
Carrot and 1½ g of paracetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma GLP-1
Time Frame: 3 hours
Glp-1 response is measured during and three hours after ingestion of the different mealtest
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma insulin
Time Frame: 3 hours
Plasma insulin is measured during and 3 hours after mealtest
3 hours
Plasma glucose
Time Frame: 3 hours
Plasma glucose is measured during and 3 hours after meal test
3 hours
Plasma GIP
Time Frame: 3 hours
Plasma GIP is measured during and 3 hours after meal test
3 hours
Plasma glucagon
Time Frame: 3 hours
Plasma glucagon is measured during and 3 hours after meal test
3 hours
Plasma PYY
Time Frame: 3 hours
Plasma PYY is measured during and 3 hours after meal test
3 hours
Plasma paracetamol
Time Frame: 3 hours
Plasma paracetamol is measured during and 3 hours after meal test
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

October 13, 2011

First Submitted That Met QC Criteria

October 17, 2011

First Posted (Estimate)

October 18, 2011

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diet oil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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