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Can the use of the PPAR-gamma agonist rosiglitazon reverse the abnormal distribution of fat, as well as disturbances in glucose and lipid metabolism in HIV-associated lipodystrophy syndrome?


- candidate number1809
- NTR NumberNTR518
- ISRCTNISRCTN78808170
- Date ISRCTN created26-feb-2007
- date ISRCTN requested13-dec-2005
- Date Registered NTR4-nov-2005
- Secondary IDsN/A 
- Public TitleCan the use of the PPAR-gamma agonist rosiglitazon reverse the abnormal distribution of fat, as well as disturbances in glucose and lipid metabolism in HIV-associated lipodystrophy syndrome?
- Scientific TitleCan the use of the PPAR-gamma agonist rosiglitazon reverse the abnormal distribution of fat, as well as disturbances in glucose and lipid metabolism in HIV-associated lipodystrophy syndrome?
- ACRONYMRosi-trial
- hypothesisRosiglitazone results in an improvement in insulin sensitivity at the level of the liver as well as peripherally. In addition disturbances in fat distribution could improve, especially in this specific group of patients, who do not use d4T nor a protease inhibitor, which are known to cause lipodystrophy.
- Healt Condition(s) or Problem(s) studiedHuman immunodeficiency virus (HIV), Lipodystrophy
- Inclusion criteria1. Male;
2. age>18 years;
3. documented HIV-1 infection;
4. HIV-RNA<50 copies/ml;
5. clinical evidence of lipodystrophy;
6. >36 weeks no use of a protease inhibitor;
7. > 24 no use of d4T, >12 weeks on a stabile regimen.
- Exclusion criteria1. Active hepatitis;
2. ALAT/ASAT>2.5x above normal level;
3. total bilirubin 2.5x above normal level;
4. lactate 2.5x above normal level;
5. anemia;
6. use of medication influencing metabolism/ blood clotting.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 3-nov-2003
- planned closingdate1-aug-2006
- Target number of participants15
- InterventionsPatients will receive either Rosiglitazon 8 mg daily (2/3) or placebo (1/3) during 4 months.
- Primary outcome1. Insulin sensitivity at the level of glucose production by liver, glucose uptake by muscle+fat and lipolysis. This will be measured by a hyperinsulinaemic clamp using stabile isotopes (d2-glucose and D5-glycerol) and by performing muscle biopsies at baseline and after 4 months;
2. Fat distribution by a DEXA- and a CT-scan at baseline and after 4 months.
- Secondary outcome1. Lipid levels;
2. Glucoregulatory hormones;
3. Adipocytokines;
4. Liver enzymes;
5. Waist-hip ratio.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES R. Blumer
- CONTACT for SCIENTIFIC QUERIESProf. Dr. H.P. Sauerwein
- Sponsor/Initiator Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline, Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- PublicationsN/A
- Brief summaryThis placebo controlled studie investigates the effects of Rosiglitazon on insulin sensitivity at central and peripheral level and on fat distribution in patients with HIV-lipodystrophy, who are not using d4T nor a protease inhibitor.
- Main changes (audit trail)
- RECORD4-nov-2005 - 2-dec-2008


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