Timing Estrogen After MenoPaUSe

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of the current study is to test whether the effect of estrogen on insulin metabolism depends on the timing of treatment relative to when a woman went through menopause. The investigators hypothesize that estrogen will improve insulin sensitivity in early postmenopausal women, but decrease insulin sensitivity in late postmenopausal women.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• aged 45-70 yr

• postmenopausal (no menses ≥12 mo or bilateral oophorectomy and FSH >30 IU/L)

• ≤6yrs or ≥10yrs of menopause (last menses or oophorectomy)

• BMI <30 kg/m2 and weight stable (±2kg in past 2mo)

• non-smokers

• sedentary to moderately active (<3 days/wk of structured exercise)

• naïve to estrogen-based hormone therapies (previous use ≤6 months)

• CBC, CMP and TSH values within normal ranges specified by lab

Exclusion Criteria:

• underwent a partial hysterectomy (i.e., one or both ovaries left intact)

• underwent menopause (natural, chemical, or surgical) prior to age 45yr

• are between >6yr and <10yr of menopause (last menses or oophorectomy)

• previously used (>6 mo) or are currently using any formulation of estrogen-based HT (e.g., oral Premarin, transdermal 17beta-estradiol, selective estrogen receptor modulators)

• have T2DM or are being treated with glucose-lowering/ insulin sensitizing medications

• have uncontrolled hypertension (SBP>140 and/or DBP>90 mmHg)

• have hypertriglyceridemia (>400 mg/dL)

• have contraindications to estrogen therapy (history of venous thromboembolism, heart disease, myocardial infarction, hormone sensitive cancer)

• have contraindications to biopsies (severe anemia, blood clotting disorders)