PULSE Study



 

Study Type
Women's Health
Study Purpose
This study will compare how weight loss or improved insulin sensitivity caused by dieting, exercise training, use of insulin sensitizing medication (metformin), or no treatment affects ovulation and reproductive health in women with PCOS.
About the Study

Do you have an irregular menstrual cycle?

Did you know this could be due to a condition called Polycystic Ovary Syndrome and could lead to other symptoms including weight gain, insulin resistance, bad cholesterol, metabolic issues and problems becoming pregnant? This research study is looking to see if losing weight or improving insulin resistance can help regulate menstrual cycles and improve fertility.

Pennington Biomedical Research Center is looking for females to participate in a woman’s health research study. The purpose of this research study is to determine how three different treatment plans impact ovulation and reproductive health in women.

Study Design

Number of visits:

  • 2 Screening visits
  • 22 Clinic visits
  • 4 Overnight visits

Study procedures:

  • FSH Responsiveness test
  • Frequent blood sampling
  • Doubly Labeled Water (DLW)
  • Accelerometry
  • DXA scan
  • MRI
  • VO2 Max test
  • Euglycemic hyperinsulinemic clamp
  • Oral Glucose Tolerance Test (OGTT)

Eligible participants will be randomly assigned to one of three groups:

  • Exercise training
  • Dietary restriction
  • Metformin treatment
  • No treatment

Participants will complete baseline testing, a 22-26 week (about 6 months) research intervention with biweekly visits to the center, interim testing and after research intervention testing (called month 6 testing).

All study-related medication and procedures will be provided at no cost to participants.
Study Qualifications
  • Female
  • Age: 20-40 years old
  • Weight: BMI (25 and above) calculate your BMI
  • Have an irregular menstrual period
Study Duration
10 months
Compensation
Earn up to $1500 for participation
Study Contact
If you are interested in volunteering for PULSE, click here to screen online, call 225-763-3000 or email clinicaltrials@pbrc.edu

If you think you may be eligible, please click the button below to screen online.



Please do not fill out this questionnaire for anyone other than yourself unless you are their legal guardian.
If you know someone who may be interested please direct them to the site or have them call us directly at 225-763-3000.

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