Condition category
Not Applicable
Date applied
09/01/2006
Date assigned
09/01/2006
Last edited
01/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.R. Soeters

ORCID ID

Contact details

Academic Medical Center
Dept of Endocrinology & Metabolism
F5-162
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 7672/9111
M.R.Soeters@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR517

Study information

Scientific title

Acronym

FIOS: Fatty acid Induced Oxidative Stress

Study hypothesis

Elevated levels of Free Fatty Acids during fasting induce oxidative stress and cause insulin resistance to maintain euglycemia.

Ethics approval

Not provided at time of registration

Study design

Non-randomised open label placebo controlled crossover group trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Other

Patient information sheet

Condition

No condition, healthy person

Intervention

Subjects will undergo a period of fasting and are assigned to receive either acipimox (inhibitor lipilysis) 250 mg 4dd or placebo. Hereafter insulin sensitivity will be measured using stable isotope technique. Furthermore regulating hormones and lipids will be measured. Muscle specimens (v. lateralis) will be obtained for determination of intramyocellular lipids and transcription factors.

Intervention type

Drug

Phase

Not Specified

Drug names

acipimox

Primary outcome measures

Insulin resistance, Free fatty acids and oxidative stress with and without acipimox.

Secondary outcome measures

Other measures of glucosehomeostasis: glucoregulatory hormones, (adipo)cytokines.

Overall trial start date

01/01/2006

Overall trial end date

01/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. 6 healthy men
2. 18-38 years
3. Body mass index (BMI) 20-25
4. Stable weight during the last 3 months

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

6

Participant exclusion criteria

1. Diabetes
2. Diabetes first degree relatives
3. Hypercholesterolemia
4. High intensity sport activities
5. Positive oral glucose tolerance testing

Recruitment start date

01/01/2006

Recruitment end date

01/03/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Endocrinology and Metabolism
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (Netherlands), Department of Endocrinology and Metabolism

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes