Ultrasound Characterization of Ovarian Morphology During Weight Loss in Women With Polycystic Ovary Syndrome (PCOS)

• Ovulation during a weight loss intervention in women with PCOS [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  

• Endometrial development during a weight loss intervention in women with PCOS [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  
• Changes in metabolism and body composition during a weight loss intervention in women with PCOS [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
  

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders occurring in women of reproductive age. PCOS is considered a syndrome of ovarian dysfunction that is characterized by the heterogeneous clinical manifestation of infrequent or absent menstrual cycles, hyperandrogenism, and polycystic ovarian morphology. Since the majority of patients also present with obesity, insulin resistance, dyslipidemia, and/or other risk factors for metabolic syndrome, there is a definite need for the development of therapeutic strategies to help these women lose weight and improve their metabolic and reproductive function.

At present, there is evidence to suggest that the loss of as little as 5-10% of body weight through prescribed diet and lifestyle interventions can improve symptomology in women with PCOS. However, the mechanism whereby weight loss specifically stimulates ovulation and restores menstrual cyclicity is unclear. Hence, the goal of this study is to explore the effects of weight loss on ovarian morphology, metabolism, and body composition in overweight and obese women with PCOS. The researchers believe that a dietary intervention based on the nutritional recommendations of the USDA Dietary Guidelines for Americans, and supported by the Obesity Society and American Diabetes Association, will reduce the degree of metabolic disturbances and consequently restore healthy ovarian follicle development in women with PCOS.

To accomplish these objectives, 30 overweight (BMI 25-29.9 kg/m^2) or obese (BMI ≥ 30 kg/m^2) women with PCOS will be evaluated every-other-day by 3D transvaginal ultrasonography during a 4-week baseline interval and 12-week commercial weight loss program (Nutrisystem® D). Participants will range in age from 18 - 38 and will not have used hormonal contraception, fertility therapies, or insulin sensitizers in the three months prior to enrollment. Ultrasound scans of the ovaries will be assessed for the total number and size of follicles using both two- and three-dimensional imaging techniques. Participants will have blood samples collected every visit to track changes in LH, FSH, estrogens, and progesterone during the scanning interval. The following metabolic parameters will be assessed at Week 2 of the baseline interval and Weeks 6 and 12 of the commercial weight loss program: (1) 75-gram oral glucose tolerance test to characterize glucose and insulin dynamics at 0, 30, 60, 90, and 120 minutes post-glucose ingestion; (2) dual X-ray absorptiometry (DXA) scan to quantify body fat and lean muscle distribution; (3) vitals and anthropometry assessment to measure waist and hip circumference, height, weight, blood pressure, and heart rate, and (4) fasting blood tests to detect androgens (i.e., total testosterone, androstenedione, free androgen index) and serum markers of metabolic syndrome (i.e., lipids and hemoglobin A1C).