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CompletedNCT01453842Updated Dec 2, 2014

Diet Oil Induced Stimulation of GLP-1

An Early Phase 1 interventional study of Diet oil and Olive oil in Type 2 Diabetes Mellitus, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-12-02.

Sponsored by University of Copenhagen · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Glucagon-like peptide-1
  • Glucose-dependant insulinotropic polypeptide
  • Glucagon
  • Peptide PYY
  • 2-oleyl glycerol
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 12 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • kidney disease
  • liver disease
  • retinopathy
  • anaemia
  • use of insulin
  • use of GLP-1 analogues
  • use of DPP-4 inhibitors
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Diet oil

    Dietary Supplement: Diet oil

  • Active comparator
    Olive oil

    Dietary Supplement: Olive oil

  • Placebo comparator
    Carrot

    Dietary Supplement: Carrot

Interventions

  • Dietary supplementDiet oil

    Carrot and diet oil (containing 2-OG) and 1½ g of paracetamol

  • Dietary supplementOlive oil

    Carrot and olive oil and 1½ g of paracetamol

  • Dietary supplementCarrot

    Carrot and 1½ g of paracetamol

06

What researchers measure

Primary outcomes

  1. Plasma GLP-1

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

    Time frame: 3 hours

Secondary outcomes

  1. Plasma insulin

    Plasma insulin is measured during and 3 hours after mealtest

    Time frame: 3 hours

  2. Plasma glucose

    Plasma glucose is measured during and 3 hours after meal test

    Time frame: 3 hours

  3. Plasma GIP

    Plasma GIP is measured during and 3 hours after meal test

    Time frame: 3 hours

  4. Plasma glucagon

    Plasma glucagon is measured during and 3 hours after meal test

    Time frame: 3 hours

  5. Plasma PYY

    Plasma PYY is measured during and 3 hours after meal test

    Time frame: 3 hours

  6. Plasma paracetamol

    Plasma paracetamol is measured during and 3 hours after meal test

    Time frame: 3 hours

07

Study locations

1 site
  • Department of Clinical Physiology
    Glostrup, 2600, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01453842
Lead sponsor
University of Copenhagen
Responsible party
Katrine Bagge Hansen (MD, University of Copenhagen) — Principal investigator
First posted
Oct 18, 2011
Start date
Mar 2011
Primary completion
Dec 2011
Completion
Mar 2012
Last update
Dec 2, 2014

Study contacts

Katrine B Hansen, MD
study chair · University of openhagen
Jens J Holst, Professor
study chair · University of Copenhagen
Harald S Hansen, Professor
study chair · University of Copenhagen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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