NCT00624104

Brief Summary

The purpose of the study is to investigate and compare the lipid metabolism in lean and obese individuals. We want to investigate the effect of postprandial hyperinsulinaemia on VLDL-triglyceride metabolism

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

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

First Submitted

Initial submission to the registry

February 18, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 7, 2011

Status Verified

November 1, 2011

Enrollment Period

2.8 years

First QC Date

February 18, 2008

Last Update Submit

November 4, 2011

Conditions

Obesity

Keywords

VLDLKineticsHyperinsulinaemiaObesity

Outcome Measures

Primary Outcomes (1)

  • VLDL metabolism

    Few hours

Study Arms (2)

1

Lean male

Dietary Supplement: Food (fat free meal)

2

Males with type 2 diabetes

Dietary Supplement: Food (fat free meal)

Interventions

Food (fat free meal)DIETARY_SUPPLEMENT

Fat free meal (40% of REE)

12

Eligibility Criteria

Age20 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Males with diabetes from departments out-patient clinic. Control group of healthyt volunteers

You may qualify if:

  • \- Written consent

You may not qualify if:

  • Known diseases
  • Alcohol abuse
  • Smoker
  • Regular use of medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology M, Aarhus Hospital

Aarhus C, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

specimen of muscle specimen of adipose tissue

MeSH Terms

Conditions

ObesityHyperinsulinism

Interventions

Food

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2008

First Posted

February 26, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

November 7, 2011

Record last verified: 2011-11

Locations

DK(1)