FP09-4 Carbohydrate Modified Diet and Insulin Sensitizers Lower Ghrelin in Empowir (Enhance the Metabolic Profile of Women with Insulin Resistance) - a Randomized Clinical Trial (NCT00618071) of Normoglycemic Hyperinsulinemic Women With Midlife Weight Gain

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: FP09-Obesity: Physiologic Responses to Energy Balance Disruption
Bench to Bedside
Saturday, June 15, 2013: 11:00 AM-11:30 AM
Presentation Start Time: 11:15 AM
Room 307 (Moscone Center)

Poster Board SAT-660
Harriette Rosen Mogul*1, Ruth G Freeman2, Gregory Cruikshank3 and Michael Frey4
1New York Med Coll, Valhalla, NY, 2Montefiore Med Ctr, Bronx, NY, 3Einstein-Montefiore Institute for Clinical and Translational Research, Bronx, NY, 4New York Medical College, Valhalla, NY
Ghrelin (Ghr) is a potent orexigen with a well defined role in meal initiation, food intake and long-term body weight (BW) regulation.1 Ghr has been implicated in hyperphagia of Prader Willi Syndrome,2 3appetite dysregulation from sleep deprivation,4 and weight loss associated with bariatric surgery.5 Ghr levels typically rise with diet-induced weight loss5, 6 and are believed to contribute to weight regain as part of a complex adaptive process.7 Strategies to diminish this rise might avert weight regain. EMPOWIR, is a double blind, placebo controlled, randomized trial of a novel carbohydrate modified diet (CMD) alone, and in combination with metformin (MF) 2000mg & MF plus rosiglitazone (RSG) in women with Syndrome W—an early manifestation of insulin resistance, defined by the triad of Weight gain (≥20 lbs after the 20´s), Waist gain, and White Coat hypertension in normoglycemic hyperinsulinemic Women.8 The study was conducted to test the hypothesis that insulin sensitizers along with CMD could reduce fasting insulin and BW. CMD is a flexible food plan (40% carbohydrates - 40% protein - 20% fat) promoting increased intake of vegetables, low-glycemic index fruits, low-fat protein & dairy products, restriction of all free sugars, & notable postponement of 3 allowable additional carbohydrates (starches) to after 4PM as previously reported.9, 10 The selected macronutrient composition reflects research on ad libitum intake11 and protein induced ghrelin suppression.12, 13 METHODS We assessed total Ghr (RIA, Millipore, Boston) and BW at baseline & 6-months at a single study site (n=22; 32% white, 41% black, 18% Hispanic, 9% other) mean age 46.2, BMI 31.1kg/m2; metabolic study criteria: normal GTT & AUC-insulin>100μU/ml. Paired t-tests & multivariate models were used (SPSS 19). Participants attended 4 weekly nutrition workshops prior to randomization. RESULTS Significant BW reductions were observed in all groups (P´s=.049, .005, .017). Mean basal Ghr declined significantly (1392±113.8 →1149±75 pg/ml, P= .001) in all groups (1240→1084 P=.046, 1052→878, P=.057 and 1984→1529 P=.031pg/ml); with Ghr reductions in 20 of 22 subjects. DISCUSSIONS Our data are consistent with most,14-19 but not all20-22 comparable intervention studies. CONCLUSION Significant Ghr decline was noted after weight loss with CMD alone, and in combination with insulin sensitizers in diverse midlife women. These findings contrast with the results of most dietary studies and merit additional study.

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Disclosure: HRM: Principal Investigator, GlaxoSmithKline, Clinical Researcher, Eli Lilly & Company. Nothing to Disclose: RGF, GC, MF

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm

Sources of Research Support: EMPOWIR is an unsolicited, investigator-initiated study supported by Glaxo Smith Kline with additional support from a Clinical and Translational Science Award (CTSA) from the National Institutes of Health UL11RR025740 awarded to the GCRC at Einstein.