PULSE Study



 

Study Type
Women's Health
Study Purpose

Do you have an irregular menstrual cycle?

Did you know irregular menstrual cycles may be caused by a condition called Polycystic Ovary Syndrome which can lead to other symptoms including weight gain, insulin resistance, bad cholesterol, metabolic issues and problems becoming pregnant? The PULSE study is looking to see if losing weight or improving insulin resistance can help regulate menstrual cycles and improve fertility.

The purpose of the PULSE Study is to test 3 different commonly recommended therapies for PCOS: exercise, losing weight through a healthy diet, and insulin sensitizing medication. Our hope is to learn how each affects ovulation and reproductive health. The PULSE study could also help health care providers design future recommendations for their PCOS patients.

About the Study

There is no cure for polycystic ovary syndrome. So, when a woman is diagnosed with PCOS, her health care provider frequently advises her to exercise, lose weight and may prescribe Metformin (to help with insulin resistance). These three recommendations have been shown together to help women with PCOS, but why and how they help is not understood.

In the PULSE Study, participants are placed into either an exercise training program, a dietary restriction program, an insulin sensitizing medication program (metformin), or a no treatment group for 6 months but is monitored.

Potential participants complete screening visits to see if they qualify for the study. Individuals do not need to be previously diagnosed with PCOS to pre-qualify for this study; a history of irregular menstrual cycles allows for an individual to screen for the study.

Study Design

If you qualify during the screening process, you will be randomly assigned to one of three groups for your 6 month program:

  • Exercise training
  • Dietary restriction
  • Medication treatment (Metformin or Placebo)

During your program, you are asked to visit the Pennington Biomedical Research Center every other week for a checkup.

You will complete testing before and after your 6 month program. Also, if you begin to ovulate during your program, an additional round of testing (similar to your before and after testing) will be conducted.

The following measurements will be collected before and after your 6 month program:

  • Body composition (body fat % and lean mass %)
  • Reproductive health and ovulation
  • Metabolism
  • Physical activity
  • Insulin Resistance

Summary of the number of visits:

  • 2 Screening visits
  • 22 Clinic visits
  • 4 Overnight visits
All study-related medications and procedures will be provided at no cost to participants. You may also be provided your results at the end of study upon request.
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 would like to discuss the PULSE study more or have any questions, a member of the Reproductive Endocrinology and Women’s Health Laboratory is available at 225-763-2886.

If you are ready to volunteer 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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