Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans (NCT05073237) | Clinical Trial Compass
WithdrawnPhase 2
Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans
Stopped: withdrawn
United States0Started 2024-04-08
Plain-language summary
The purpose of this study is to determine the effect of a novel menopause hormone therapy on blood sugar (glucose) and blood and liver fats (lipids) in obese menopausal women Veterans.
Who can participate
Age range50 Years – 60 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:
Postmenopausal women veterans within 5 years of menopause.
Menopause is defined as:
* women with intact uterus and last menstrual period \>1 year ago but \<5 years ago
* Age 50-60 years
* BMI 27-34.9kg/m2 (Overweight and low risk Class 1 Obesity)
* Symptomatic (moderate to severe vasomotor symptoms)
* Fasting glucose 100-150mg/dl or/or HbA1c \>5.7%- and \<7% (two abnormal test can be fasting glucose or HbA1c or combination of the two in the past 6 months).
* Triglycerides \< 200 mg/dl
* GFR \>60mL/min
* Normal mammogram within the past 12 months
Exclusion Criteria:
* Amenorrhea from other causes (Hyperandrogenemia and anovulation)
* Recent weight change (\>10 lbs in the last 3 months), intended or unintended
* Vulnerable populations (employees, students, individuals with impaired decision making capacity, pregnant women, prisoners, terminally ill, and children)
* Change in lipid lowering agent in the last 3 months
* Use of glucose lowering agents in the last 3 months
* Concurrent conditions including HIV, uncontrolled hyperthyroidism, uncontrolled hypothyroidism or less than 3 months since addition or change in thyroid hormone modulating medications, current use of drugs known to promote significant weight changes, menopause hormone therapy use within 3 months
* Contraindications to estrogens (history of thromboembolic disorder, coronary artery or cerebrovascular disease, clotting disorders (Antiphospholipid antibody syndrome, protein C deficiency, pr…
What they're measuring
1
change in beta cell function
Timeframe: Change in beta cell function between baseline and 16 weeks