Actively Recruiting
Cardiometabolic Consequences of the Loss of Ovarian Function
Led by University of Colorado, Denver · Updated on 2024-06-20
100
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and fat gain, and risk of disease in women as they age. The first aim in this study will determine whether short term and long term low estrogen levels in premenopausal women decreases artery function and whether this is related to an increase in fat in the stomach area. The second aim will determine whether the changes in artery health and body fat are related to changes in a pathway that breaks down an important amino acid called tryptophan. This pathway is thought to play a role in regulating the aging process. Therefore, the investigators will determine whether the decrease in artery health and the increase in body fat in the stomach region with low estrogen is related to changes in this pathway in the blood, in vascular cells and fat tissue. Because estrogen levels fluctuate in premenopausal women, the investigators will use an approach (intervention) that controls estrogen levels to address these aims. The investigators will use a medication that is typically used to treat endometriosis or uterine fibroids to lower estrogen levels and an estrogen patch to increase estrogen in some women. Some women will receive a patch that has no estrogen (called a placebo patch). The intervention period will be 20 weeks. The study will provide us with new knowledge on how low estrogen with menopause affects artery health and fat gain estrogen.
CONDITIONS
Official Title
Cardiometabolic Consequences of the Loss of Ovarian Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 to 45 years
- Premenopausal with normal menstrual cycles defined as no more than one missed cycle in the past year
- Not pregnant or planning to become pregnant
- Not lactating in the last 3 months
- Serum FSH less than 10 IU/L measured during days 1-10 of the menstrual cycle
- No hormonal contraception use in the last 3 months
- Sedentary or recreationally active with less than 2 days per week of vigorous exercise
- No use of medications that affect vascular function such as antihypertensives, lipid-lowering drugs, or blood thinners
- No use of antioxidant supplements or chronic NSAIDs or willing to stop them 4 weeks before enrollment
You will not qualify if you...
- Diabetes or fasting glucose over 126 mg/dL
- Body mass index over 35 kg/m2
- Weight change greater than 5 kg in the last 3 months
- Use of glucocorticoids or drugs affecting glucocorticoid metabolism in the last 3 months
- Excess alcohol consumption defined as more than 14 drinks per week
- Known allergy to study medications
- Depressive symptoms with CES-D score over 16
- Resting blood pressure over 150/90 mmHg
- History of cardiac, kidney, or liver disease
- Active or chronic infections
- Thyroid dysfunction with TSH less than 0.5 or greater than 5.0 mU/L
- Smoking or tobacco use within the past 12 months
- Severe low bone mass or osteoporosis with hip or spine T-score less than -2.0
- History of venous thromboembolic event
- History of breast cancer or other estrogen-dependent tumors
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
K
Kerrie Moreau, PhD
CONTACT
C
Claire Cox, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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