nctId: NCT06264882 id: 23-1518 id: U54AG062319 type: NIH link: https://reporter.nih.gov/quickSearch/U54AG062319 briefTitle: Cardiometabolic Consequences of the Loss of Ovarian Function acronym: LILAC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-05-31 date: 2028-08-31 date: 2024-02-20 date: 2024-02-20 name: University of Colorado, Denver class: OTHER name: National Institute on Aging (NIA) briefSummary: 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: Menopause conditions: Estrogen Deficiency conditions: Aging conditions: Adiposity studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Degarelix name: Transdermal Estradiol Patch name: Transdermal Placebo Patch measure: Brachial artery flow mediated dilation (FMD) measure: Visceral fat area (VFA) measure: Subcutaneous fat area measure: Tryptophan-Kynurenine metabolites measure: Body composition - mass measure: Body composition - bone measure: Oxidized LDL measure: Total antioxidant status measure: Pro-inflammatory cytokines measure: Blood lipids and lipoproteins measure: Blood glucose measure: Insulin measure: Adipokines measure: Physical activity levels measure: Endothelial cell protein measures measure: Ex vivo serum exposure studies measure: Cerebrovascular function measure: Arterial Stiffness measure: Carotid artery stiffness measure: Blood pressure measure: Self reported sleep quality measure: Cognitive function sex: FEMALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: University of Colorado Anschutz Medical Campus city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 hasResults: False