title: Effects of transdermal testosterone administration on insulin sensitivity, fat mass and distribution, and markers of inflammation and thrombolysis in human immunodeficiency virus-infected women with mild to moderate weight loss.
abstract: OBJECTIVE
  To determine the effects of raising serum T levels into the high normal female range by transdermal T administration on insulin sensitivity, fat volume, and markers of inflammation and thrombolysis in HIV-infected women with recent weight loss.
  
  
  METHODS
  Placebo-controlled, randomized clinical trial.
  
  
  METHODS
  Academic clinical research center.
  
  
  METHODS
  Fifty-two HIV-infected, menstruating women with >5% weight loss over the prior 6 months and current T<33 ng/dL.
  
  
  METHODS
  Placebo or T patches twice weekly for 24 weeks to achieve nominal delivery of 300 microg T daily.
  
  
  METHODS
  Testosterone by liquid chromatography-tandem mass spectrometry, insulin sensitivity by the frequently sampled intravenous glucose tolerance test (FSIVGT), abdominal and thigh fat volumes by magnetic resonance imaging (MRI), and C-reactive protein (CRP) as a measure of inflammation and plasminogen-activated inhibitor-1 (PAI-1) levels as a marker of thrombolysis.
  
  
  RESULTS
  Serum and free T levels significantly increased into the high normal female range in T-treated but not placebo-treated women. Insulin sensitivity by FSIVGT, whole body, thigh SC, and intra-abdominal fat volumes, and CRP and PAI-1 levels did not change significantly in either group and were not significantly different between the two groups. Fasting insulin increased in the placebo group and fell slightly in the T group, resulting in significant differences in change between groups.
  
  
  CONCLUSIONS
  Twenty-four weeks of elevation of serum T levels into the high normal female range in HIV-infected women with mild to moderate weight loss by transdermal T patches did not adversely affect insulin sensitivity, whole-body fat mass or regional fat distribution, or markers of inflammation and thrombolysis. More prolonged and larger studies are needed to determine the effects of higher doses of T on body composition and insulin sensitivity in women.
authors.affiliation: Division of Endocrinology, Metabolism, and Molecular Medicine, Department of Internal Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, California, USA. Karen.herbst@med.va.gov
authors.forename: Karen L
authors.initials: KL
authors.lastname: Herbst
authors.forename: Olga M
authors.initials: OM
authors.lastname: Calof
authors.forename: Stanley H
authors.initials: SH
authors.lastname: Hsia
authors.forename: Indrani
authors.initials: I
authors.lastname: Sinha-Hikim
authors.forename: Linda J
authors.initials: LJ
authors.lastname: Woodhouse
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Buchanan
authors.forename: Shalender
authors.initials: S
authors.lastname: Bhasin
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D015415:Biomarkers / Q000097:blood; D050218:Body Fat Distribution / Q000706:statistics & numerical data*; D002140:California / Q000453:epidemiology; D015897:Comorbidity; D016207:Cytokines / Q000097:blood*; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000503:physiopathology*; D020249:Hormone Replacement Therapy / Q000706:statistics & numerical data*; D006801:Humans; D007249:Inflammation / Q000097:blood / Q000453:epidemiology; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D008875:Middle Aged; D015990:Placebo Effect; D012720:Severity of Illness Index; D013739:Testosterone / Q000008:administration & dosage*; D013927:Thrombosis / Q000097:blood / Q000453:epidemiology; D015431:Weight Loss
chemical_list: D015415:Biomarkers; D016207:Cytokines; D007328:Insulin; D013739:Testosterone