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Effects of Diet and Exercise and/or Rosiglitazone on Body Composition and Lipids including Oxidized LDL in HIV+ and HIV- Men and Women
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Reported by Jules Levin
15th CROI, Feb 3-6, 2008, Boston
David J. Mun, M.S.1, Ellen S. Engelson, Ed.D.1,2, Jeanine B. Albu, M.D.1,2, Mimansa Sharma, M.S.2, Teodor C Pitea, M.D.2, Donald P. Kotler, M.D.1,2
1 Columbia University College of Physicians and Surgeons, New York, NY, US and 2St. Luke's Roosevelt Hospital Center, New York, NY, US
note from Jules Levin: I've emailed to the NATAP listserve in the past few days several findings from several published studies reporting reduced bone mineral density and increased risk for fractures associated with use of glitazones-rosiglitazone and piolglitazone. The finding occurred in postmenopausal women and in men. Considering the added risk of reduced bone mineral density, osteopenis, and osteoporosis in HIV, these risks ought to be considered in the context of using glitazones for diabetes and to treat fat loss.
32 HIV-negative and HIV+ on ART were prospectively randomized to 1 of 3 treatments and evaluated for changes in body composition (whole body MRI & DEXA) and lipids:
-- Rosi (8 mg daily) alone
-- diet, exercise (promote loss of 2 lbs/week), & placebo (DEAP)
-- diet, exercise, & Rosi (DEAR)
AUTHOR DISCUSSION
· Baseline lipid panels, including Ox LDL, are not different in centrally obese, insulin resistant HIV- and HIV+ subjects.
· Rosi increased leg fat, trunk fat, and total body fat, but did not change VAT. The addition of diet and exercise reversed the increases in fat due to Rosi.
· There was a trend of increasing Ox LDL, Ox LDL/LDL and triglycerides from Rosi, and a significant decrease in Ox LDL from DEAR. The trends from Rosi may have been significant with a larger sample size.
· Body composition and lipid changes due to Rosi and DEAR were similar in people with and without HIV. The greater decrease in Ox LDL in HIV+ on DEAP may be reflective of greater compliance to the recommended diet and exercise, which is indicated by greater decreases in weight, BMI, leg fat, trunk fat, total fat, and % body fat in the HIV+ group compared to the HIV- group on DEAP.
Rosiglitazone and Diet+Exercise have opposite effects. The effect of diet and exercise is stronger than the effect of Rosi.
BACKGROUND
· Body-fat abnormalities, insulin resistance (IR), and lipid abnormalities are common in HIV+ adults on antiretroviral therapy (ART).(1)
· Rosiglitazone (Rosi), an anti-diabetic drug, improves IR in HIV+ adults on ART, and Rosi is believed to improve body fat distribution.(2)
· Rosi is believed to increase risk of myocardial infarction and lipid abnormalities.(3,4) This is especially a concern in a population who have increased cardiovascular disease risks, such as oxidized LDL (Ox LDL), due to HIV infection and ART use.(5)
· The following study is aimed at showing the effect of Rosi and lifestyle modifications on abnormalities common to HIV + patients on ART.
OBJECTIVES
· To study the in vivo effects of diet, exercise, and Rosi for 16 weeks on:
- body fat distribution
- lipids including Ox LDL (6)
· To compare the effects in HIV+ and HIV- people with aspects of the metabolic syndrome
METHODS
· 16 week, prospective, randomized trial
· HIV+ and HIV- men and women 20-60 yrs. of age, with waist circumferences
>88.2 cm in men and >75.3 cm in women, fasting serum insulin > 16 mU/ml, and BMI > 25
· Treatments:
- Rosi (8 mg daily) alone
- diet, exercise (promote loss of 2 lbs/week), & placebo (DEAP)
- diet, exercise, & Rosi (DEAR)
· Measurements:
- Body composition: whole body MRI & DEXA
- Fasting lipids by standard methods
- Ox LDL in frozen fasting plasma: competitive ELISA (Mercodia, Sweden)(6)
· Data analysis:
- Comparison of HIV groups: Student's t-test & Fisher's Exact Test
- Treatment comparison: ANOVA with Tukey's HSD test for post-hoc analysis
- Lipid results were controlled for smoking
- Variables showing trends (P<0.20) for correlations were chosen for multiple regression analysis of Ox LDL
- Data presented as mean ± standard deviation
- Significance level of p<0.05
RESULTS
32 subjects enrolled. 27 completed 16-week trial.
Age: 44 ± 9 years
Sex, physical activity status, race, and age were not significantly different between HIV status or treatment groups.
The HIV+ had lower BI, leg fat, trunk fat and total fat than HIV-negatives.
Rosiglitazone increased body fat in periphery; diet & exercise decreased body fat in the periphery; for patients who used rosiglitazone + diet/exercise body fat declined but not by as much with rosi+diet/exercise.
Rosiglitazone increased weight 1.7 kg, BMI by 2.1%, leg fat by 12.6%, trunk fat by 9.2%, total fat by 7.3%, percent body fat by 3.8%, and SAT increased, but VAT did not.
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