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Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS

Phase 3
20 Years
40 Years
Open (Enrolling)
Polycystic Ovary Syndrome

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Trial Information

Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS

The goal of this study is to determine (using dietary restriction, exercise training,
metformin or no treatment), the effects of weight loss and/or improved insulin sensitivity
on reproductive function (neuroendocrine and ovarian) in obese women with Polycystic ovary

Inclusion Criteria:

- 20 - 40 years, inclusive

- Body mass index ≥ 25 kg/m2

- History of irregular menstrual cycles (fewer than 6 cycles in the past year)

- Clinical and/or biochemical androgen excess (Free androgen index>3.85 and/or
hirsuitism rating ≥8)

- Anovulatory menstrual cycles (determined during screening)

Exclusion Criteria:

- Ovulatory menstrual cycles (determined during screening by luteal phase serum
progesterone >3ng/mL)

- History or clinical appearance of cardiovascular disease, diabetes (Type 1 or Type 2)
and any other significant reproductive, metabolic, hematologic, pulmonary,
gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer.

- Hemoglobin, hematocrit, red blood cell count, or iron level below the lower limit of
normal at the screening visit confirmed by a test repeated within two weeks

- Regular use of medications for weight control, glucose intolerance, thyroid disease

- Use of hormonal contraception containing medroxyprogesterone acetate (A 3 month
washout period will be permitted for oral, vaginal and transdermal contraceptives).

Psychiatric and Behavioral Exclusion Criteria

- Smoking

- History of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past
two years

- History or presence of an eating disorder as determined by Interview for Diagnosis of
Eating Disorders (IDED-IV)

- Beck Depression Index (BDI) score of ≥15 at screening or baseline

Other Exclusion Criteria

- Individuals who have lost more than 5kg (11lbs) in the past 6 months

- Individuals who are pregnant or breast-feeding or whom become pregnant during the

- Individuals engaged in a regular program of physical fitness involving some heavy
physical activity (e.g., jogging or riding fast on a bicycle for 30 minutes or more)
at least five times per week over the past year

- Individuals who have metallic objects in their body

- Individuals who donated blood within 30 days prior to the date of randomization

- Individuals unwilling to be assigned at random to either one of the intervention

- Unwilling or unable to adhere to the rigors of the data collection (determined by
food and activities diaries at screening, see below) and clinical evaluation schedule
over the entire 24 week intervention period

- Individuals who plan to move out of the area within the next 12 months or plan to be
out of the study area for more than 4 weeks in the next 12 months

- Individuals who reside too far from Pennington

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Pulsatility profile of Luteinizing Hormone (LH)

Outcome Description:

Change in LH pulsatility measured over 12h (7pm - 7am)

Outcome Time Frame:

Baseline, Week 24

Safety Issue:


Principal Investigator

Leanne M Redman, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Pennington Biomedical Research Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2012

Completion Date:

December 2014

Related Keywords:

  • Polycystic Ovary Syndrome
  • Exercise
  • Diet
  • Insulin resistance
  • Weight
  • Polycystic Ovary Syndrome
  • Insulin Resistance



Pennington Biomedical Research Center Baton Rouge, Louisiana  70808