Effects of menopause on artery health and fat gain in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research investigates how the decrease in estrogen during menopause affects artery health and fat accumulation, particularly in the abdominal area, which may increase the risk of heart disease. The study aims to determine the relationship between low estrogen levels and vascular function in premenopausal women, as well as the impact of increased abdominal fat on vascular health. Additionally, it explores the role of the tryptophan-kynurenine pathway in these changes, which may be linked to aging and body fat regulation. Participants will receive either a transdermal estradiol patch or a placebo to assess these effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age criteria of 20-45 years: the investigators are determining the effects of ovarian suppression on adiposity and vascular in premenopausal women;
* Premenopausal defined as normal menstrual cycle function defined as no more than 1 missed cycle in the previous year: irregular menstrual or missed menstrual cycles could indicate that women are anovulatory and/or perimenopause;
* Not pregnant or planning to become pregnant;
* Not lactating in the last 3 months;
* Serum FSH \<10 IU/L measured during days 1-10 of the menstrual cycle: to ensure the woman is premenopausal and not perimenopausal;
* Not on hormonal contraception in the last 3 months;
* Sedentary or recreationally active (\<2 days/wk vigorous exercise);
* No use of medications that might influence vascular function (i.e., antihypertensives, lipid lowering medications, blood thinners);
* No use of antioxidant supplements or chronic NSAIDs or be willing to go off them for 4 weeks prior to enrollment in the study;

Exclusion Criteria:

* Diabetic or fasted glucose \>126 mg/dL;
* Body mass index (BMI) \>35 kg/m2;
* Weight change \>5 kg in the last 3 months;
* Use of glucocorticoids (inhaled, oral, topical) or drugs that affect glucocorticoid metabolism (e.g., ketoconazole) in the last 3 months;
* Excess alcohol consumption, defined as \>14 drinks per week by self-report;
* Known hypersensitivity to study medications;
* Depressive symptoms, defined as a CES-D score \>16;
* Resting blood pressure \>150/90 mmHg;
* Preexisting or active cardiac, renal, or hepatic disease: past or current history of these diseases or conditions;
* Active or chronic infection: inflammation associated with active or chronic infections impair vascular function;
* Thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal TSH values will be reconsidered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement;
* Smoking or Tobacco use within the previous 12 months;
* Severe low bone mass or osteoporosis, defined as a hip or lumbar spine T-score \<-2.0: safety reasons, women who are randomized to the ovarian suppression plus placebo group could see a decrease in bone mineral density due to the suppression of estrogen;
* History of venous thromboembolic event (VTE): safety reasons, estradiol therapy can increase the risk of VTE;
* History of breast cancer or other estrogen-dependent neoplasm: estradiol therapy is contraindicated;

Where it's running

• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Kerrie Moreau, PhD — University of Colorado Denver Anschutz Medical Campus
• Study coordinator: Kerrie Moreau, PhD
• Email: kerrie.moreau@cuanschutz.edu
• Phone: 303-724-1914

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sex hormones, menopause, and exercise in aging women

  This study tests how hormonal status and resistance training affect age-related muscle and nerve function in postmenopausal women.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT07848438

• Beta3-adrenergic Receptors and Vascular Function in Aging Women

  This trial tests whether activating beta3-adrenergic receptors can improve blood vessel function in aging women undergoing menopause.

  Recruiting Early Phase 1 University of Missouri-Columbia · Columbia, Missouri · NCT07674680

• Adherence to a creatine-based nutritional supplement in estrogen-depleted women

  This 12-week observational project will test how well estrogen-depleted women stick to taking a creatine-based nutritional supplement.

  Recruiting at 3 sites Margan Biotech · Madrid, Madrid and 3 other locations · NCT07580846

• Understanding how menopause affects body temperature regulation

  This study tests how menopause affects body temperature control in women aged 42-64 by comparing responses to heat in those with low estrogen and those with higher estrogen levels.

  Recruiting Phase 4 Penn State University · University Park, Pennsylvania · NCT06798571

• Examining how aging and menopause affect blood vessel responses to low oxygen levels

  This study is testing how aging and menopause affect blood vessel responses to low oxygen levels in women by trying different medications to see how they help.

  Recruiting Early Phase 1 University of Missouri-Columbia · Columbia, Missouri · NCT06417177

• Subdermal estradiol and testosterone implants for relieving menopausal symptoms

  This project will try bioabsorbable subdermal estradiol and testosterone implants in women with menopause-related estrogen and testosterone deficiency to see if they reduce menopausal and sexual symptoms.

  Recruiting Phase 3 University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT06343870

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.