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Fatty Acid Induced Oxidative Stress: it's role in preventing hypoglycemia.


- candidate number1804
- NTR NumberNTR517
- ISRCTNISRCTN85121743
- Date ISRCTN created9-jan-2006
- date ISRCTN requested13-dec-2005
- Date Registered NTR3-nov-2005
- Secondary IDsN/A 
- Public TitleFatty Acid Induced Oxidative Stress: it's role in preventing hypoglycemia.
- Scientific TitleFatty Acid Induced Oxidative Stress: it's role in preventing hypoglycemia.
- ACRONYMFIOS: Fatty acid Induced Oxidative Stress
- hypothesisElevated levels of Free Fatty Acids during fasting induce oxidative stress and cause insulin resistance to maintain euglycemia.
- Healt Condition(s) or Problem(s) studiedNo condition, healthy person
- Inclusion criteria1. 6 healthy men;
2. 18-38 years;
3. BMI 20-25;
4. stable weight during the last 3 months.
- Exclusion criteria1. Diabetes;
2. diabetes first degree relatives;
3. hypercholesterolemia;
4. high intensity sport activities;
5. positive oral glucose tolerance testing.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupCrossover
- Type[default]
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate1-mrt-2006
- Target number of participants6
- InterventionsSubjects will undergo a period of fasting and are assigned to receive either acipimox (inhibitor lipilysis) 250mg 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 transscription factors.
- Primary outcomeInsulin resistance, Free fatty acids and oxidative stress with and without acipimox.
- Secondary outcomeOther measures of glucosehomeostasis: glucoregulatory hormones, (adipo)cytokines.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. M.R. Soeters
- CONTACT for SCIENTIFIC QUERIESMD. M.R. Soeters
- Sponsor/Initiator Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- PublicationsN/A
- Brief summaryDuring fasting hypoglycemia must be prevented to protect glucosedependent tissues. Insulin resistance is a mechanism to do so. Free fatty acids play a major role in this process. Also there is a role for oxidative stress that inhibits insulin mediated glucose uptake by several proposed mechanisms. Lipolysis can be inhibited bij acipimox wich will result in a decrease in FFA levels. Hypothetically FFA inhibition decreases oxidative stress with a concomitant decrease in insulin resistance.
- Main changes (audit trail)
- RECORD3-nov-2005 - 11-nov-2008


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