title: Carbohydrate modified diet & insulin sensitizers reduce body weight & modulate metabolic syndrome measures in EMPOWIR (enhance the metabolic profile of women with insulin resistance): a randomized trial of normoglycemic women with midlife weight gain.
abstract: BACKGROUND
  Progressive midlife weight gain is associated with multiple adverse health outcomes and may represent an early manifestation of insulin resistance in a distinct subset of women. Emerging data implicate hyperinsulinema as a proximate cause of weight gain and support strategies that attenuate insulin secretion.
  
  
  OBJECTIVE
  To assess a previously reported novel hypocaloric carbohydrate modified diet alone (D), and in combination with metformin (M) and metformin plus low-dose rosiglitazone (MR), in diverse women with midlife weight gain (defined as >20lbs since the twenties), normal glucose tolerance, and hyperinsulinemia.
  
  
  METHODS
  46 women, mean age 46.6±1.0, BMI 30.5±0.04 kg/m2, 54.5% white, 22.7% black, 15.9% Hispanic, at 2 university medical centers.
  
  
  METHODS
  A dietary intervention designed to reduce insulin excursions was implemented in 4 weekly nutritional group workshops prior to randomization.
  
  
  METHODS
  Change in 6-month fasting insulin. Pre-specified secondary outcomes were changes in body weight, HOMA-IR, metabolic syndrome (MS) measures, leptin, and adiponectin.
  
  
  RESULTS
  Six-month fasting insulin declined significantly in the M group: 12.5 to 8.0 µU/ml, p = .026. Mean 6-month weight decreased significantly and comparably in D, M, and MR groups: 4.7, 5.4, and 5.5% (p's.049, .002, and.032). HOMA-IR decreased in M and MR groups (2.5 to 1.6 and 1.9 to 1.3, p's = .054, .013). Additional improvement in MS measures included reduced waist circumference in D and MR groups and increased HDL in the D and M groups. Notably, mean fasting leptin did not decline in a subset of subjects with weight loss (26.15±2.01 ng/ml to 25.99±2.61 ng/ml, p = .907. Adiponectin increased significantly in the MR group (11.1±1.0 to 18.5±7.4, p<.001) Study medications were well tolerated.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00618072.
authors.affiliation: Department of Medicine, Division of Endocrinology, New York Medical College, Valhalla, New York, United States of America.
authors.forename: Harriette R
authors.initials: HR
authors.lastname: Mogul
authors.affiliation: Departments of Medicine and Obstetrics and Gynecology, Albert Einstein College of Medicine, Bronx, New York, United States of America.
authors.forename: Ruth
authors.initials: R
authors.lastname: Freeman
authors.affiliation: Department of Medicine, Division of Endocrinology, New York Medical College, Valhalla, New York, United States of America.
authors.forename: Khoa
authors.initials: K
authors.lastname: Nguyen
authors.affiliation: Department of Medicine, Division of Endocrinology, New York Medical College, Valhalla, New York, United States of America.
authors.forename: Michael
authors.initials: M
authors.lastname: Frey
authors.affiliation: Department of Medicine, Division of Endocrinology, New York Medical College, Valhalla, New York, United States of America.
authors.forename: Lee-Ann
authors.initials: LA
authors.lastname: Klein
authors.affiliation: Departments of Medicine and Obstetrics and Gynecology, Albert Einstein College of Medicine, Bronx, New York, United States of America.
authors.forename: Sheila
authors.initials: S
authors.lastname: Jozak
authors.affiliation: Department of Medicine, Division of Endocrinology, New York Medical College, Valhalla, New York, United States of America.
authors.forename: Karen
authors.initials: K
authors.lastname: Tanenbaum
mesh_terms: D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D001835:Body Weight; D050528:Diet, Carbohydrate-Restricted / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007333:Insulin Resistance; D020738:Leptin / Q000378:metabolism; D024821:Metabolic Syndrome / Q000378:metabolism* / Q000628:therapy*; D008875:Middle Aged; D010349:Patient Compliance; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D020738:Leptin