VLDL-triglyceride Under Acute Hyperinsulinaemia | NCT00624104

Studies
VLDL-triglyceride Under Acute Hyperinsulinaemia

NCT00624104

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Nov 7, 2011Estimated

Enrollment

16Actual

Phase

Not provided

Conditions

Obesity

Interventions

Food (fat free meal)

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

Nov 2011

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 2008

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Feb 18, 2008

First Submission Date that Met QC Criteria

Feb 25, 2008

First Posted Date

Feb 26, 2008Estimated

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

Nov 4, 2011

Last Update Posted Date

Nov 7, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

Retention

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Lean male	Dietary Supplement: Food (fat free meal)
2		Males with type 2 diabetes	Dietary Supplement: Food (fat free meal)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Food (fat free meal)	Dietary Supplement	Fat free meal (40% of REE)	1 2

Measure	Description	Time Frame
VLDL metabolism		Few hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Written consent

Exclusion Criteria:

Known diseases
Alcohol abuse
Smoker
Regular use of medicine

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology M, Aarhus Hospital		Aarhus C		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D006946	Hyperinsulinism

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005502	Food

Ancestor Terms

ID	Term
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided