Prevention of Obesity in Women Via Estradiol Regulation

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate potential mechanisms by which estradiol deficiency accelerates fat gain and abdominal fat accumulation in women.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: National Institute on Aging (NIA)
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Leuprolide; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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