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Diet Oil Induced Stimulation of GLP-1

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Diet oil
Olive oil
Carrot
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Glucagon-like peptide-1, Glucose-dependant insulinotropic polypeptide, Glucagon, Peptide PYY, 2-oleyl glycerol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Clinical Physiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Diet oil

Olive oil

Carrot

Arm Description

Outcomes

Primary Outcome Measures

Plasma GLP-1
Glp-1 response is measured during and three hours after ingestion of the different mealtest

Secondary Outcome Measures

Plasma insulin
Plasma insulin is measured during and 3 hours after mealtest
Plasma glucose
Plasma glucose is measured during and 3 hours after meal test
Plasma GIP
Plasma GIP is measured during and 3 hours after meal test
Plasma glucagon
Plasma glucagon is measured during and 3 hours after meal test
Plasma PYY
Plasma PYY is measured during and 3 hours after meal test
Plasma paracetamol
Plasma paracetamol is measured during and 3 hours after meal test

Full Information

First Posted
October 13, 2011
Last Updated
December 1, 2014
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01453842
Brief Title
Diet Oil Induced Stimulation of GLP-1
Official Title
Diet Oil Induced Stimulation of GLP-1
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Glucagon-like peptide-1, Glucose-dependant insulinotropic polypeptide, Glucagon, Peptide PYY, 2-oleyl glycerol

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet oil
Arm Type
Experimental
Arm Title
Olive oil
Arm Type
Active Comparator
Arm Title
Carrot
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Diet oil
Intervention Description
Carrot and diet oil (containing 2-OG) and 1½ g of paracetamol
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive oil
Intervention Description
Carrot and olive oil and 1½ g of paracetamol
Intervention Type
Dietary Supplement
Intervention Name(s)
Carrot
Intervention Description
Carrot and 1½ g of paracetamol
Primary Outcome Measure Information:
Title
Plasma GLP-1
Description
Glp-1 response is measured during and three hours after ingestion of the different mealtest
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Plasma insulin
Description
Plasma insulin is measured during and 3 hours after mealtest
Time Frame
3 hours
Title
Plasma glucose
Description
Plasma glucose is measured during and 3 hours after meal test
Time Frame
3 hours
Title
Plasma GIP
Description
Plasma GIP is measured during and 3 hours after meal test
Time Frame
3 hours
Title
Plasma glucagon
Description
Plasma glucagon is measured during and 3 hours after meal test
Time Frame
3 hours
Title
Plasma PYY
Description
Plasma PYY is measured during and 3 hours after meal test
Time Frame
3 hours
Title
Plasma paracetamol
Description
Plasma paracetamol is measured during and 3 hours after meal test
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrine B Hansen, MD
Organizational Affiliation
University of openhagen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jens J Holst, Professor
Organizational Affiliation
University of Copenhagen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Harald S Hansen, Professor
Organizational Affiliation
University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Clinical Physiology
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

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Diet Oil Induced Stimulation of GLP-1

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