|
|
|
|
|
|
Sponsored by: |
National Institute on Aging (NIA) |
Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00687739 |
The purpose of this study is to evaluate potential mechanisms by which estradiol deficiency accelerates fat gain and abdominal fat accumulation in women.
Condition | Intervention | Phase |
Obesity |
Drug: leuprolide acetate Drug: Estradiol Transdermal Behavioral: progressive resistance exercise training |
Phase III |
MedlinePlus related topics: | Exercise and Physical Fitness Obesity |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Estrogen Deficiency and Mechanisms of Fat Accumulation |
Estimated Enrollment: | 300 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Placebo Comparator
GnRH agonist + placebo
|
Drug: leuprolide acetate
3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
|
2: Active Comparator
GnRH agonist + placebo + exercise
|
Drug: leuprolide acetate
3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Behavioral: progressive resistance exercise training
45 minute exercise sessions 4 times per week for 5 months
|
3: Experimental
GnRH agonist + E2
|
Drug: leuprolide acetate
3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Drug: Estradiol Transdermal
0.075 mg patch per day for 5 months
|
4: Experimental
GnRH agonist + E2 + exercise
|
Drug: leuprolide acetate
3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Drug: Estradiol Transdermal
0.075 mg patch per day for 5 months
Behavioral: progressive resistance exercise training
45 minute exercise sessions 4 times per week for 5 months
|
Many factors contribute to the current epidemic of obesity. Although estrogen status is not commonly recognized as a determinant of obesity risk in women, there is strong evidence from large randomized controlled trials that estradiol- (E2) based hormone therapy (HT) reduces weight gain by about 40% in postmenopausal women. Importantly, there is also strong evidence that E2 reduces abdominal fat accumulation, a fundamental component of the Metabolic Syndrome. Some studies suggest risks of HT outweigh the benefits for some women. However, this does not negate the importance of learning the mechanisms by which E2 influences energy balance and fat patterning.
This study uses gonadotropin releasing hormone (GnRH) analog therapy to determine the effects of chronic (5-month) sex hormone suppression on resting energy expenditure (REE), altered hypothalamic-pituitary-adrenal (HPA) axis activity, and fat gain.
It is hypothesized that REE will be reduced in response to chronic sex hormone suppression, promoting fat gain. It is also hypothesized that stress-induced HPA axis activity will be amplified during sex hormone suppression; altered HPA axis activity leading to cortisol excess causes abdominal fat accumulation. Finally, it is hypothesized that E2 add-back therapy will lessen these responses.
Participants will be randomized so that half of the women in each treatment arm will participate in an exercise training program, consisting of progressive resistance exercise to prevent the decline in fat-free mass (FFM) and the increase in fat mass that has been observed in young women in response to GnRH analog therapy.
Ages Eligible for Study: | 20 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ellie Gibbons, BA | 720-848-6408 | Ellie.Gibbons@UCHSC.edu |
United States, Colorado | |||||
University of Colorado Denver | Recruiting | ||||
Aurora, Colorado, United States, 80045 | |||||
Contact: Ellie Gibbons, BA 720-848-6408 Ellie.Gibbons@UCHSC.edu | |||||
Principal Investigator: Wendy M Kohrt, PhD | |||||
Sub-Investigator: Wendolyn S Gozansky, MD, MPH |
Principal Investigator: | Wendy M Kohrt, PhD | University of Colorado Denver |
Responsible Party: | University of Colorado Denver ( Wendy M Kohrt, PhD ) |
Study ID Numbers: | AG0103, R01AG018198 |
First Received: | May 29, 2008 |
Last Updated: | May 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00687739 |
Health Authority: | United States: Federal Government |
|
|
|
|
|
|