Diet Oil Induced Stimulation of GLP-1

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Diet Oil Induced Stimulation of GLP-1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453842
• Other study ID #: Diet oil
• Status: Completed
• Phase: Phase 0
• First received: October 13, 2011
• Last updated: December 1, 2014
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: December 2014
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Diet oil
Carrot and diet oil (containing 2-OG) and 1½ g of paracetamol
• Olive oil
Carrot and olive oil and 1½ g of paracetamol
• Carrot
Carrot and 1½ g of paracetamol

Locations

Country	Name	City	State
Denmark	Department of Clinical Physiology	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma GLP-1	Glp-1 response is measured during and three hours after ingestion of the different mealtest	3 hours	No
Secondary	Plasma insulin	Plasma insulin is measured during and 3 hours after mealtest	3 hours	No
Secondary	Plasma glucose	Plasma glucose is measured during and 3 hours after meal test	3 hours	No
Secondary	Plasma GIP	Plasma GIP is measured during and 3 hours after meal test	3 hours	No
Secondary	Plasma glucagon	Plasma glucagon is measured during and 3 hours after meal test	3 hours	No
Secondary	Plasma PYY	Plasma PYY is measured during and 3 hours after meal test	3 hours	No
Secondary	Plasma paracetamol	Plasma paracetamol is measured during and 3 hours after meal test	3 hours	No