Diet Oil Induced Stimulation of GLP-1 | NCT01453842

Studies
Diet Oil Induced Stimulation of GLP-1

NCT01453842

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Dec 2, 2014Estimated

Enrollment

12Actual

Phase

Early Phase 1

Conditions

Type 2 Diabetes Mellitus

Interventions

Diet oil
Olive oil
Carrot

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Mar 2012Actual

First Submitted Date

Oct 13, 2011

First Submission Date that Met QC Criteria

Oct 17, 2011

First Posted Date

Oct 18, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2014

Last Update Posted Date

Dec 2, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Diet oil	Experimental	Dietary Supplement: Diet oil
Olive oil	Active Comparator	Dietary Supplement: Olive oil
Carrot	Placebo Comparator	Dietary Supplement: Carrot

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diet oil	Dietary Supplement	Carrot and diet oil (containing 2-OG) and 1½ g of paracetamol	Diet oil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma GLP-1	Glp-1 response is measured during and three hours after ingestion of the different mealtest	3 hours

Secondary Outcomes

Measure	Description	Time Frame
Plasma insulin	Plasma insulin is measured during and 3 hours after mealtest	3 hours
Plasma glucose	Plasma glucose is measured during and 3 hours after meal test

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Physiology		Glostrup Municipality		2600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004032	Diet
D000069463	Olive Oil

Ancestor Terms

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D004042	Dietary Fats, Unsaturated

Browse Leaves

Not provided

Browse Branches

Not provided