NCT01453842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for early_phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2011

Shorter than P25 for early_phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

October 13, 2011

Last Update Submit

December 1, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

Glucagon-like peptide-1Glucose-dependant insulinotropic polypeptideGlucagonPeptide PYY2-oleyl glycerol

Outcome Measures

Primary Outcomes (1)

  • Plasma GLP-1

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

    3 hours

Secondary Outcomes (6)

  • Plasma insulin

    3 hours

  • Plasma glucose

    3 hours

  • Plasma GIP

    3 hours

  • Plasma glucagon

    3 hours

  • Plasma PYY

    3 hours

  • +1 more secondary outcomes

Study Arms (3)

Diet oil

EXPERIMENTAL
Dietary Supplement: Diet oil

Olive oil

ACTIVE COMPARATOR
Dietary Supplement: Olive oil

Carrot

PLACEBO COMPARATOR
Dietary Supplement: Carrot

Interventions

Diet oilDIETARY_SUPPLEMENT

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

Diet oil
Olive oilDIETARY_SUPPLEMENT

Carrot and olive oil and 1½ g of paracetamol

Olive oil
CarrotDIETARY_SUPPLEMENT

Carrot and 1½ g of paracetamol

Carrot

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Physiology

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

DietOlive Oil

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodFood and Beverages

Study Officials

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 18, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

DK(1)