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The SCALE Study

Are you an Apple or a Pear?


Are you an Apple or a Pear Graphic Cartoon

Sex hormones,
Cortisol, and
Adiposity
Loss via
Exercise

 

The rate of fat gain (especially abdominal fat) in women increases after menopause. The SCALE study will examine the separate effects of 1) the female sex hormone, estrogen and 2) weight loss on the stress hormone, cortisol. Cortisol is known to increase abdominal fat, which is associated with an increased risk for heart disease and adult onset diabetes.

SCALE participants will receive either an estrogen patch or a placebo (inactive substance) patch for four weeks only (Phase 1). Then all women will stop using the patches and take part in a four-month weight loss program involving exercise and some dieting to reduce body weight by at least 5% (Phase 2).

 

Phase 1 (4 weeks) Phase 2 (4 months)
Estrogen or Placebo Supervised Exercise Weight Loss Program

 

 

The main inclusion criteria for this study:

  • Healthy postmenopausal women aged 40-59 years
  • Non-smoking
  • Not currently taking hormone therapy
  • Willing to wear an estrogen or placebo patch for 1 month
  • Able to take part in a 4-month supervised aerobic exercise program

Benefits for study volunteers include:

  • Measurement of body composition and bone density
  • Fitness testing
  • Comprehensive diet analysis
  • Personalized and supervised exercise program

This study is funded by the National Institutes of Health and has been approved by the Colorado Multiple Institutional Review Board (protocol # 07-0278)

 

Frequently Asked Questions Regarding the SCALE Study:

  1. Will I be paid for participation in this study?
    The compensation for finishing this study is $300. If the study is not completed for any reason, compensation is provided at $100 for each testing period (baseline, phase 1 and phase 2 testing).
  2. Where do I go for study testing and supervised exercise sessions?
    All of our testing and exercise training will be on the Anschutz Medical Campus (Fitzsimons Campus) in Aurora (I-225 and Colfax).
  3. How long will I be in this study?
    Participating in the SCALE study should take approximately seveb months from the start of the screening process until the completion of the study.
  4. What are the benefits I will receive from this study?
    The SCALE study will allow you to learn more about your current health, including your bone density, percent body fat, aerobic fitness, resting metabolic rate, risk for diabetes and routine blood tests. You will also receive a personalized exercise training program during the research study.
  5. Why would I want to wear an estrogen patch for four weeks?
    The patch will temporarily raise your estrogen levels back to what they were before menopause. While estrogens have been shown to prevent abdominal fat gain, improve bone mineral density, and prevent the development of diabetes, estrogens also have been associated with an increased risk of breast cancer, stroke, heart attacks, blood clots and dementia. However, the use of estrogen for four weeks is unlikely to result in either the benefits or harms listed above. The goal of this study is to try to understand the mechanisms behind the beneficial effects of estrogens so that new and safer therapies can be developed to help postmenopausal women stay healthy in the future.
  6. I'm interested in learning more about my current health status and understanding the importance of an active lifestyle. What is the next step?
    If you are interested in participating, let me know, and I will send you the consent form so that you can read through it and find out all of the specific details about the study. You will also need to fill out a screening form that will ask you some general information regarding your health, so that we can make sure that you will qualify for the study. Please call or email me with any questions or concerns.