title: METFORMIN-SUSTAINED WEIGHT LOSS AND REDUCED ANDROID FAT TISSUE AT 12 MONTHS IN EMPOWIR (ENHANCE THE METABOLIC PROFILE OF WOMEN WITH INSULIN RESISTANCE): A DOUBLE BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL OF NORMOGLYCEMIC WOMEN WITH MIDLIFE WEIGHT GAIN.
abstract: OBJECTIVE
  To assess 12-month body weight (BW) and body composition changes in normoglycemic women with midlife weight gain, after dietary and pharmacologic interventions targeting hyperinsulinemia.
  
  
  METHODS
  EMPOWIR (Enhance the Metabolic Profile of Women With Insulin Resistance; NCT00618072) was a double-blind, placebo-controlled, 12-month trial of women with >20-pound weight gain, normal glucose tolerance test, and increased area-under-the-curve insulin. Subjects (mean ± SD, 46.7 ± 6.5 years of age; body mass index, 30.8 ± 2.8 kg/m(2); 50% white) attended 4 nutrition workshops to introduce a novel carbohydrate-modified diet (CMD) and were then randomized to one of three arms for 6 months (phase 1): CMD alone (D), or in combination with metformin (M), or metformin + rosiglitazone (MR), with rerandomization of the D group to one of the active treatment arms (phase 2, months 7 through 12). Repeated measure analysis of variance was used to assess BW at baseline, 6 months, and 12 months in 32 subjects with 12-month data; paired t tests compared baseline and 12-month dual-energy X-ray absorptiometry-derived body composition.
  
  
  RESULTS
  Mean (±SD) BW decreased significantly at 12 months in the M arm: 85.1 ± 8.5 kg to 79.8 ± 9.0 kg (P = .0003), with 54% of variance in weight over time explained by M treatment. Mean (±SD) percent android fat decreased significantly in the M and D arms: 53.5 ± 4.8% to 49.3 ± 7.6% (P = .010) and 52.9 ± 6.2% to 48.1 ± 8.7% (P = .021).
  
  
  CONCLUSIONS
  In combination with a novel carbohydrate modified diet, metformin enhanced 12-month weight loss and improved body composition in ethnically diverse normoglycemic, hyperinsulinemic women with midlife weight gain. These findings suggest that EMPOWIR's easily implemented dietary interventions, alone and in combination with pharmacotherapies that target hyperinsulinemia, merit additional investigation in larger, long-term studies.
authors.forename: Harriette
authors.initials: H
authors.lastname: Mogul
authors.forename: Ruth
authors.initials: R
authors.lastname: Freeman
authors.forename: Khoa
authors.initials: K
authors.lastname: Nguyen
mesh_terms: D000273:Adipose Tissue / Q000187:drug effects* / Q000378:metabolism; D000328:Adult; D000375:Aging / Q000187:drug effects / Q000378:metabolism; D050218:Body Fat Distribution; D002979:Climacteric / Q000187:drug effects / Q000502:physiology; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007333:Insulin Resistance; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D009765:Obesity / Q000178:diet therapy / Q000188:drug therapy* / Q000378:metabolism; D050177:Overweight / Q000178:diet therapy / Q000188:drug therapy* / Q000378:metabolism; D010919:Placebos; D013844:Thiazoles / Q000627:therapeutic use; D015430:Weight Gain / Q000187:drug effects; D015431:Weight Loss / Q000187:drug effects*
chemical_list: D004338:Drug Combinations; D010919:Placebos; D013844:Thiazoles; C471074:rosiglitazone-metformin combination; D008687:Metformin