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Effect of Pharmacological Anti-lipolysis on FFA and VLDL-TG Metabolism Before and During Exercise

NCT ID: NCT01260376

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-09-30

Brief Summary

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This study will investigate free fatty acid and VLDL-TG metabolism before and during exercise with and without pharmacological antilipolysis by the niacin antagonist Acipimox. Main focuses will be VLDL-TG and free fatty acid metabolism as well as expression of membrane proteins in fat- and muscle biopsies.

Detailed Description

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Insulin resistance in liver and skeletal muscle is of central pathogenic significance in the development of type 2 diabetes. The molecular connections are unresolved but high levels of free fatty acids and triglyceride is probably involved. Diabetic subjects and to a lesser extent obese subjects have increased triglyceride levels, this could be due to an abnormal turnover of VLDL-TG. It is not yet investigated whether VLDL-TG kinetics changes during pharmacological antilipolysis. Using the aseptic ex-vivo labeling technique (developed in our laboratories) we will investigate this issue in sedentary healthy men. After a 3 hour basal period subjects will exercise on a bike for 60 minutes at 60% of VO2max. In both basal and exercise period one muscle and one fat biopsy will be obtained, further blood samples will be drawn to examine FFA and VLDL-TG metabolism etc..

This new knowledge will contribute to the understanding of metabolic disorders like type 2 diabetes and obesity.

Conditions

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Diabetes Obesity

Keywords

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VLDL-TG Metabolism Exercise Free Fatty Acids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Acipimox

Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day

Group Type EXPERIMENTAL

Acipimox

Intervention Type DRUG

Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day

Placebo

Placebo tablets will be administered 4 times previous to and during the investigation day

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acipimox

Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- healthy, untrained males

Exclusion Criteria

* medication
* history of malignancy, alcohol abuse or drug abuse
* participation in isotope trials in the last 6 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Birgitte Nellemann

MD PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soren Nielsen, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Aarhus

Locations

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University Hospital of Aarhus, Norrebrogade

Aarhus, Aarhus, Denmark

Site Status

University Hospital of Aarhus, Norrebrogade

Aarhus, Aarhus, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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M-20100221

Identifier Type: -

Identifier Source: org_study_id