NCT01043445

Brief Summary

The purpose of this study is to evaluate the impact of different ligands of GPR 119 (a G protein-coupled receptor in the intestine) on the secretion of the incretin hormones, GLP-1 and GIP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable type-2-diabetes

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

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

December 2, 2009

Last Update Submit

October 8, 2014

Conditions

Type 2 Diabetes

Keywords

GPR 119GLP-1 secretion2-oleoyl-glycerolDietary supplementation

Outcome Measures

Primary Outcomes (1)

  • The effect of this newly discovered GPR 119 agonist on gut hormone responses, in particular GLP-1 in response of the different meals administered to the subjects

    1 year

Secondary Outcomes (1)

  • Glucose homeostasis, gall bladder contraction in response of the different meals administered to the subjects

    1 year

Study Arms (3)

GPR119 agonist, 2-oleoyl glycerol

EXPERIMENTAL

2-oleoyl glycerol; 2g. and vehicle

Dietary Supplement: GPR 119 agonist, 2-oleyl glycerolDietary Supplement: Vehicle

Oleic acid

ACTIVE COMPARATOR

oleic acid; 3.2g and vehicle

Dietary Supplement: Oleic acidDietary Supplement: Vehicle

Vehicle

PLACEBO COMPARATOR

5 ml. of glycerol and 5 ml 96% ethanol

Dietary Supplement: Vehicle

Interventions

GPR 119 agonist, 2-oleyl glycerolDIETARY_SUPPLEMENT

Emulgation, 50 ml. containing 2g 2OG

GPR119 agonist, 2-oleoyl glycerol
Oleic acidDIETARY_SUPPLEMENT

Emulgation, 50 ml. containing 1.54g of oleic acid

Oleic acid
VehicleDIETARY_SUPPLEMENT

Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol

GPR119 agonist, 2-oleoyl glycerolOleic acidVehicle

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy caucasians v- Normal OGTT (75 g of glucose) according to WHO's criteria
  • Normal hemoglobin
  • Informed consent

You may not qualify if:

  • Liver disease (ALAT\> 2x normal level)
  • Nephropathy (s-creatinin \>130 microM or albuminuria)
  • Relatives with type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Physiology, Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Oleic Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Oleic AcidsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Study Officials

  • Katrine B Hansen, MD

    Glostrup Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Filip K Knop, MD, Ph.d

    Gentofte Hospital

    STUDY DIRECTOR

  • Harald S Hansen, professor

    Farmaceutical Faculty, University of Copenhagen

    STUDY DIRECTOR

  • Jens J Holst, MD;DMSc

    Biomedical Science, University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.d

Study Record Dates

First Submitted

December 2, 2009

First Posted

January 6, 2010

Study Start

September 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

October 9, 2014

Record last verified: 2014-10

Locations

DK(1)