Status:
COMPLETED
Prevention of Obesity in Women Via Estradiol Regulation
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Obesity
Eligibility:
FEMALE
18-49 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate potential mechanisms by which estradiol deficiency accelerates fat gain and abdominal fat accumulation in women.
Detailed Description
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 randomize...
Eligibility Criteria
Inclusion
- Healthy premenopausal women, aged 18 to 49 years
- Regular menses (no missed cycles in previous year; cycle length 25-35 days)
- Positive luteinizing hormone test or a mid-luteal serum progesterone greater than 3 ng/mL
- Nonsmokers
- Willing to receive all study interventions
- Physically able and willing to be randomized to participate in a supervised resistance exercise training program
Exclusion
- Already performing high-intensity resistance exercise training more than 1 day per week
- On diabetes medications
- Use of hormonal contraception in the past 3 months
- On oral or inhaled glucocorticoids
- Positive pregnancy test
- Intention to become pregnant or start hormonal contraceptive therapy during the period of study
- Lactation
- Hypersensitivity to extrinsic peptide hormones, mannitol, Gonadotropin-releasing hormone (GnRH), leuprolide acetate, benzyl alcohol (the vehicle for injection of leuprolide acetate), or transdermal patch
- Score greater than 16 on the Center for Epidemiologic Studies Depression Scale and Beck Depression Inventory-II score greater than 18, or clinician recommendation to exclude
- Severe osteopenia or osteoporosis (proximal femur or lumbar spine t scores \< -2.0)
- BMI greater than 40 kg/m2, weight change of more than ± 2 kg in last 6 months, or weight-reduced by more than 5 kg from maximal body weight
- Abnormal vaginal bleeding
- History of breast cancer or other estrogen-dependent neoplasms
- History of venous thromboembolic events
- Moderate or severe renal impairment (creatinine clearance \<50 mL/min by Cockcroft-Gault)
- Chronic hepatobiliary disease, defined as liver function tests (AST, ALT, alkaline phosphatase, total bilirubin) greater than 1.5 times the upper limit of normal
- Thyroid dysfunction, defined as ultra sensitive TSH less than 0.5 or greater than 5.0 mU/L
- Uncontrolled hypertension, defined as resting BP greater than 150/90 mmHg
- Cardiovascular disease, including indicators of ischemic heart disease or serious arrhythmias at rest or during the graded exercise test; follow-up diagnostic testing to rule out cardiovascular disease by a cardiologist will be allowed
- Orthopedic or other problems that would interfere with participation in the exercise program
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00687739
Start Date
May 1 2008
End Date
June 1 2014
Last Update
April 1 2025
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045