Prevention of Obesity in Women Via Estradiol Regulation (NCT00687739) | Clinical Trial Compass
CompletedPhase 3
Prevention of Obesity in Women Via Estradiol Regulation
United States79 participantsStarted 2008-05
Plain-language summary
The purpose of this study is to evaluate potential mechanisms by which estradiol deficiency accelerates fat gain and abdominal fat accumulation in women.
Who can participate
Age range18 Years – 49 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 venou…
What they're measuring
1
Resting Energy Expenditure (REE)
Timeframe: Before and after 5 months of treatment
2
Cortisol Response (Area Under the Curve) to CRH Under DEX Suppression