Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans

• Status: Not yet recruiting
• Trial end date: 2024-12-16
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)

Criteria

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, protein S deficiency, AT III deficiency, factor V leiden), severe liver disease, history of breast or uterine cancer or unexplained vaginal bleeding)

• Plan for major surgery or prolonged immobilization within 6 month period

• MRI Absolute contraindications