N/A
N=53
Timing Estrogen After MenoPaUSe
Insulin Resistance
Bottom Line
View on ClinicalTrials.gov: NCT01605071 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Insulin-mediated Glucose Disposal Rate (Hyperinsulinemic-euglycemic Clamp) — 11.7; 11.5; 12.2; 10.7 mg/kg FFM/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Estradiol (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin-mediated Glucose Disposal Rate (Hyperinsulinemic-euglycemic Clamp) |
11.7; 11.5; 12.2; 10.7 | — |
| SECONDARY Skeletal Muscle Estrogen Receptor Expression |
1; 0.71; 0.92; 0.80; 1; 0.78 | — |
| SECONDARY Skeletal Muscle Estrogen Receptor Expression (Protein/Cyto Protein) |
0.94; 0.78; 1.49; 0.98; 1; 1.13 | — |
| SECONDARY Adipose Tissue Estrogen Receptor Expression |
1.58; 0.96; 1.17; 1.22; 1.44; 0.97 | — |
| SECONDARY Adipose Tissue Estrogen Receptor Expression (ERα:ERβ) |
1.47; 0.89; 1.143; 0.87 | — |
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.
Eligibility 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 6yr and 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)
Data sourced from ClinicalTrials.gov (NCT01605071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.