Trial record 20 of 30 for:    nichd Polycystic Ovary Syndrome (PCOS)

Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS (PULSE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Pennington Biomedical Research Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01482286
First received: November 28, 2011
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

Polycystic ovary syndrome (PCOS) is the most common reproductive disorder in women of reproductive age and despite decades of research the etiology the disorder is not known. The characteristic hyperandrogenism and anovulation is associated with abnormal neuroendocrine function and insulin resistance. Obesity is a common correlated phenotype of Polycystic ovary syndrome and weight gain worsens the reproductive and metabolic complications. Currently there is no evidence-based treatment plan for infertility in Polycystic ovary syndrome; yet weight loss by dietary restriction and regular exercise are strongly advocated. Weight loss and increased insulin sensitivity appear to drive improvements in reproductive outcomes in women with Polycystic ovary syndrome; however, the mechanism connecting these changes with the reproductive axis is not fully understood.


Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: Metformin
Behavioral: Dietary Restriction
Behavioral: Exercise Training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Pulsatility profile of Luteinizing Hormone (LH) [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Change in LH pulsatility measured over 12h (7pm - 7am)


Secondary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
    Change in insulin sensitivity measured by the euglycemic hyperinsulinemic clamp


Estimated Enrollment: 52
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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:
  • 25% DR
  • Calorie restriction
  • Dietary restriction
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.
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 Names:
  • Exercise training
  • 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.

Detailed Description:

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 syndrome.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482286

Contacts
Contact: Erin Lejeune, B.S. 2257632709 erin.lejeune@pbrc.edu

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Erin Lejeune, B.S.    225-763-2706    erin.lejeune@pbrc.edu   
Sub-Investigator: Frank Greenway, MD         
Sub-Investigator: Eric Ravussin, PhD         
Sub-Investigator: Karen Elkind-Hirsch, PhD         
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Leanne M Redman, PhD Pennington Biomedical Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Leanne Redman, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01482286     History of Changes
Other Study ID Numbers: PBRC11016 PULSE, R00HD060762
Study First Received: November 28, 2011
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Exercise
Diet
Insulin resistance
Weight

Additional relevant MeSH terms:
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014