10th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 6-8 November 2008, London, UK

EFFECTS OF DIET AND EXERCISE AND/OR ROSIGLITAZONE ON BODY COMPOSITION AND GLUCOSE METABOLISM IN HIV-POSITIVE AND HIV-NEGATIVE SUBJECTS

Antiviral Therapy 2008; 13(Suppl. 4):A31 (abstract no. P-13)

JB Albu, CM Kim, ES Engelson, TC Pitea and DP Kotler
St Luke’s/Roosevelt Hospital Center, Columbia University College of Physicians & Surgeons, New York, NY, USA

AIMS: We previously reported lack of improvement in glucose metabolism in obese, HIV-infected women, despite 7.3% weight loss through diet and exercise. This study compared responses to 16 weeks of diet and exercise and/or rosiglitazone in HIV-infected and uninfected men and women.

METHODS: This was a 16-week, prospective, randomized, placebo-controlled (for rosiglitazone) trial. Participants were overweight or obese and insulin resistant (fasting insulin ≥16 µU/ml) at screening. They were stratified by HIV status and gender to randomly receive 8 mg/day rosiglitazone (ROSI), hypocaloric diet and exercise training plus placebo (DEAP) or diet and exercise plus rosiglitazone (DEAR). Body composition was measured by whole body MRI and DEXA. Glucose metabolism was measured by euglycaemic hyperinsulinaemic clamp at baseline and week 16. Data are presented as mean ±sd. Statistical comparisons between baseline and follow-up were done by paired t-test, between HIV groups by Student’s t-test and between interventions by ANOVA with Bonferroni post hoc comparisons.

RESULTS: Baseline and follow-up data are currently available for 15 subjects (4 HIV-positive and 4 HIV-negative men, 3 HIV-positive and 4 HIV-negative women). At baseline, subjects weighed an average of 97.5 kg (body mass index 33.2 ±4.9 kg/m²). Weight change was significantly different between treatment groups (P=0.0006), with weight loss in DEAP (-7.4 ±3.1 kg, -7.9%, P=0.006) and DEAR (-6.4 ±4.1 kg, -6.5%, P=0.02) and gain in ROSI (2.2 ±1.5 kg, P=0.03). Skeletal muscle and visceral adipose tissue changes did not differ significantly by intervention, whereas subcutaneous adipose tissue (overall P=0.008) decreased in DEAP (-4.0 ±2.0 l, P=0.01) and DEAR (-3.5 ±1.8 l, P=0.01) but not in ROSI (P=0.50). Changes in body weight and composition were not significantly different by HIV status. For all subjects, fasting insulin at baseline was 25.4 ±10.5 U/ml and did not differ by HIV status. Glucose disposal rate (GDR) per kg fat free mass (FFM) increased in response to all interventions (P<0.03) but was greater in DEAR than in DEAP (P=0.03); DEAR and DEAP were not different from ROSI and GDR change did not differ by HIV status (P=0.3). GDR adjusted for insulin levels at steady state during the clamp (M/I) improved in all treatment groups (P<0.05) and did not differ by group (P=0.3), but less improvement was seen with HIV infection (28.3 ±22.8 versus 10.3 ±9.4, P=0.07). Suppression of endogenous glucose production (SEGP)/FFM did not change in response to any intervention (P=0.57) nor within either HIV group (P=0.35). Changes in weight and body composition did not correlate with changes in glucose metabolism except that a 0.65 ±0.62 l visceral adipose tissue decrease in DEAP correlated with M/I and SEGP/FFM improvements (P=0.03 for both).

CONCLUSIONS: Weight loss and rosiglitazone are equally effective in improving glucose metabolism. HIV status did not affect treatment responses in obese, insulin resistant individuals in this study.

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2008-11-06
P-13

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