No registrations found.
ID
Source
Brief title
Health condition
HIV+ patients, with lipodystrophy (based on fat distribution disturbances), not using d4T nor a protease inhibitor.
Sponsors and support
Prof.dr. H.P. Sauerwein
Academic medical centre, Dept of endocrinology and metabolism, F5-170, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands
Intervention
Outcome measures
Primary outcome
1. 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 outcome
1. Lipid levels;
2. Glucoregulatory hormones;
3. Adipocytokines;
4. Liver enzymes;
5. Waist-hip ratio.
Background summary
This 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.
Study objective
Rosiglitazone 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.
Study design
N/A
Intervention
Patients will receive either Rosiglitazon 8 mg daily (2/3) or placebo (1/3) during 4 months.
P.O. Box 22660
R. Blumer
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
r.blumer@amc.uva.nl
P.O. Box 22660
R. Blumer
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
r.blumer@amc.uva.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL477 |
| NTR-old | NTR518 |
| Other | : N/A |
| ISRCTN | ISRCTN78808170 |