Trial Information

Ultrasound Characterization of Follicle Dynamics During Weight Loss

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).