Obesity Clinical Trial
— CE/BZAOfficial title:
Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | May 4, 2026 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Southeast Louisiana Veterans Health Care System, New Orleans, LA | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in beta cell function | beta cell function will be evaluated via oral glucose tolerance test at baseline and after 16 weeks of treatment. | Change in beta cell function between baseline and 16 weeks | |
Secondary | change in liver fat | Change in liver fat will be evaluated via MRI-PDFF between baseline and after 16 weeks of treatment. | Change in Liver fat between baseline and 16 weeks | |
Secondary | change in serum lipidomics | Change in serum lipidomics will be evaluated via UPLC-MS/MS at baseline and after 16 weeks of treatment. | Change in serum lipidomics between baseline and 16 weeks |
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