Actively Recruiting
Effects of Lowering and Raising Estrogen Levels on Artery Health and Belly Fat in Premenopausal Women Aged 20 to 45
Led by University of Colorado, Denver · Updated on 2024-06-20
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to understand how the decrease in estrogen during menopause affects artery health, body fat distribution, and disease risk in women as they age. The study focuses on whether low estrogen levels reduce artery function and increase abdominal fat, and explores the role of a pathway that breaks down tryptophan, an amino acid linked to aging. Researchers will study these effects particularly in premenopausal women by controlling estrogen levels through medication. Participants will be randomly assigned to one of two groups one receiving degarelix acetate injections plus a placebo patch, and the other receiving degarelix acetate injections plus an estradiol patch. The patches are applied twice per week, and the injections occur at baseline and again at 10 weeks. Additionally, participants will take medroxyprogesterone acetate for 12 days at weeks 9 and 17 to prevent certain uterine changes. The intervention period lasts 20 weeks, during which estrogen levels are carefully controlled and monitored. Participants will undergo assessments of artery function and body fat at baseline, 2 weeks, and 20 weeks, including measurements of brachial artery flow-mediated dilation and visceral fat area. Compliance is tracked by clinical administration of injections and participant logs for patch use. The study also monitors vascular cells and fat tissue to investigate biochemical pathways related to aging and fat accumulation. Women will remain on their assigned treatments until all testing is complete, with ongoing monitoring to evaluate the impact of estrogen changes on cardiovascular and metabolic health.
CONDITIONS
Brief Title
Cardiometabolic Consequences of the Loss of Ovarian Function
Research Team
K
Kerrie Moreau, PhD
C
Claire Cox, BA
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