Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss
Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss
The objective of this study is to explore the effects of weight loss on body composition,
 metabolic status, reproductive hormones, and ovarian follicle development in obese women with
 regular menstrual cycles versus obese women with irregular menstrual cycles and/or polycystic
 ovary syndrome (PCOS).
Polycystic ovary syndrome (PCOS) is a complex endocrine condition that impacts one in ten
 women of reproductive age worldwide. It is characterized by a collection of signs and
 symptoms, including: (1) oligo- or anovulation, (2) hyperandrogenism, and (3) polycystic
 ovarian morphology. Because obesity worsens the reproductive and metabolic features of the
 condition, lifestyle intervention aimed at weight loss is recommended as the first-line
 therapy in overweight / obese patients. Many studies have shown that modest weight loss
 (5-10%) can improve symptomology in women with PCOS. Yet, the mechanism whereby weight loss
 might stimulate ovulation or restore menstrual cyclicity remains unclear.

 Hence, the goal of this study is to explore the effects of weight loss on body composition,
 metabolic status, reproductive hormones, and ovarian follicle development in obese women with
 regular menstrual cycles versus obese women with irregular menstrual cycles and/or PCOS. The
 researchers believe that a hypocaloric and low-glycemic index eating pattern, based on the
 nutrition recommendations of the USDA Dietary Guidelines for Americans and American Diabetes
 Association, will reduce endocrine and metabolic disturbances and consequently improve
 ovulatory and menstrual cyclicity in PCOS.

 To accomplish this objective, the researchers plan to recruit up to 50 obese (i.e. body mass
 index >30 kg/m*m) women with regular menstrual cycles and up to 50 obese women with irregular
 menstrual cycles and/or PCOS. Exclusion criteria will include ages <18 or >35 y and the use
 of hormonal contraception, fertility therapy, or insulin-sensitizing medication in the three
 months prior to enrollment. This study entails one month of data collection during a baseline
 interval (Month 1) and six months of data collection during a commercial weight loss program
 (Nutrisystem® D; Month 2 thru Month 7).

 Participants will be evaluated every other day (in Months 1 and 7) or twice per week (in
 Months 2 thru 6) by transvaginal ultrasonography and venipuncture. Ultrasound images of the
 ovaries will be assessed for the total number and diameter of individual follicles. Serum
 samples will be assessed for follicle-stimulating hormone, luteinizing hormone, estradiol,
 and progesterone. Participants will also be evaluated at up to four time points using
 multiple metabolic and behavioral tests. Time points of interest will include: (1) Month 1
 (i.e. pre-intervention), (2) after 5% weight loss, (3) after 10% weight loss, and (4) Month 7
 (i.e. post-intervention). Assessments and endpoints of interest will include: (1) fasting
 blood tests (to detect serum androgens and markers of metabolic syndrome); (2) an oral
 glucose tolerance test (to characterize glucose and insulin dynamics at 0, 30, 60, 90, and
 120-minutes post-glucose ingestion); (3) a physical examination (to measure height, weight,
 waist and hips circumference, blood pressure, heart rate, and hirsutism score); (4) a dual
 x-ray absorptiometry scan (to quantify total and regional fat and lean mass); and (5) a
 quality of life questionnaire (to evaluate health-related quality of life).

 To evaluate further changes in ovarian morphology, reproductive hormones, metabolic status,
 and body composition after the intervention, participants will be invited to return to the
 research unit six months after the study ends. The aforementioned procedures (transvaginal
 ultrasound scan; fasting blood tests; oral glucose tolerance test; physical examination; dual
 x-ray absorptiometry scan; and quality of life questionnaire) will be repeated.
Inclusion Criteria:

 -  BMI ≥ 30.0 kg/m*m.

 -  Self-reported history of regular menstrual cycles, irregular menstrual cycles, or
 PCOS.

 -  Absence of hormonal contraception, fertility therapy, or insulin-sensitizing
 medication in the three months prior to enrollment.

 Exclusion Criteria:

 -  Pregnant, breastfeeding, or lactating

 -  Lack of one or both ovaries and/or uterus

 -  Previous diagnosis of bleeding disorder(s) or current use of blood
 thinners/anticoagulants

 -  Vegan or gluten free

 -  Soy or peanut allergy