Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS (PULSE)
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ClinicalTrials.gov Identifier: NCT01482286 |
Recruitment Status :
Completed
First Posted : November 30, 2011
Last Update Posted : January 30, 2017
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Condition or disease | Intervention/treatment | Phase |
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Polycystic Ovary Syndrome | Drug: Metformin Behavioral: Dietary Restriction Behavioral: Exercise Training | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
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Experimental: Metformin
Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
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Drug: Metformin
Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
Other Name: metformin hydrochloride tablets |
Experimental: Dietary Restriction
Subjects randomized to the dietary restriction group (DR) will reduce their energy intake by 25% from their weight maintenance energy intake determined at baseline by doubly labeled water.There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical activity.
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Behavioral: Dietary Restriction
Subjects randomized to the dietary restriction group will reduce their energy intake by 25% of their weight maintenance energy intake determined at baseline. Total energy expenditure as measured by a 14-day doubly labeled water (DLW) study will be used to determine the baseline energy intake of each subject. There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical activity.
Other Names:
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Experimental: Exercise
Subjects randomized to the exercise training group will complete a structured program of aerobic training 3 to 4 times per week and resistance exercises 2 times per week.
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Behavioral: Exercise Training
For the aerobic training component, subjects are required to meet a weekly energy expenditure target of 10 kcal per kg of body weight per week (KKW). The resistance training program will be performed 2 days a week. The resistance program includes 9 exercises. The 9 primary exercises are seated chest press, seated row, shoulder press, lat pull down, double leg press, leg extension, leg curl, back extension and abdominal crunch. Other Name: Aerobic and resistance training |
No Intervention: Control
Subjects randomized to the no treatment control group will be asked to continue, as normal their usual dietary and exercise regimen. Subjects will be asked to not begin diet or exercise regimens through the 24-week study or to begin medical treatment for PCOS.
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- Pulsatility profile of Luteinizing Hormone (LH) [ Time Frame: Baseline, Week 24 ]Change in LH pulsatility measured over 12h (7pm - 7am)
- Insulin sensitivity [ Time Frame: Baseline and week 24 ]Change in insulin sensitivity measured by the euglycemic hyperinsulinemic clamp

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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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 study
- 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 groups
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482286
United States, Louisiana | |
Pennington Biomedical Research Center | |
Baton Rouge, Louisiana, United States, 70808 |
Principal Investigator: | Leanne M Redman, PhD | Pennington Biomedical Research Center |
Additional Information:


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Leanne Redman, Principal Investigator, Pennington Biomedical Research Center |
ClinicalTrials.gov Identifier: | NCT01482286 History of Changes |
Other Study ID Numbers: |
PBRC11016 R00HD060762 ( U.S. NIH Grant/Contract ) |
First Posted: | November 30, 2011 Key Record Dates |
Last Update Posted: | January 30, 2017 |
Last Verified: | January 2017 |
Exercise Diet Insulin resistance Weight |
Polycystic Ovary Syndrome Insulin Resistance Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders |
Endocrine System Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Insulin Metformin Hypoglycemic Agents Physiological Effects of Drugs |