Effects of menopause and aging on weight gain and fat distribution
Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women - 2018
This study is testing how menopause affects weight gain and belly fat in women by looking at hormones and seeing if adjusting these hormones can help reduce fat.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04043520 on ClinicalTrials.gov |
What this trial studies
This study investigates how menopause affects weight gain and fat distribution, particularly focusing on the role of the stress hormone cortisol. It aims to determine if low estrogen levels in premenopausal and early postmenopausal women lead to increased cortisol levels, which may contribute to abdominal fat accumulation. The study will also explore whether reducing follicle-stimulating hormone (FSH) levels can decrease belly fat and improve related health factors. Participants will undergo hormone manipulation using a GnRH antagonist and estrogen patches to assess these effects.
Who should consider this trial
Good fit: Ideal candidates are healthy peri/postmenopausal women aged 6 months to 7 years past their last menstrual period with elevated FSH levels.
Not a fit: Patients currently on hormonal contraceptives or menopausal therapy, or those with certain health conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatments for managing weight gain and reducing disease risk in menopausal women.
How similar studies have performed: Other studies have shown promising results in understanding hormonal influences on weight gain, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Volunteers will be healthy peri/postmenopausal women who are willing and able to undergo the proposed hormone manipulation and study procedures. Women will be at least 6 months but not more than 7 years past the last menstrual period (i.e., late perimenopausal or early postmenopausal) with FSH \>30 IU/L. We will make a major effort to ensure that the women enrolled in this study come from all races and ethnicities and a wide range of socioeconomic and educational levels. Women will be excluded for the reasons listed below. Exclusion Criteria: * abnormal vaginal bleeding * on hormonal contraceptive or menopausal therapy or intention to start during the period of study * positive pregnancy test or intention to become pregnant during the period of study * lactation * known hypersensitivity to degarelix acetate, estradiol, or medroxyprogesterone acetate * Center for Epidemiological Studies Depression Scale (CES-D) score \<,16 (unless clinician follow-up and clinical judgement determine they are eligible (will be noted in study chart) * current tobacco and/or vape use more than 2 times/week * current marijuana or tetrahydrocannabinol (THC) use in any form more than 3 times/week * regular self-reported alcohol consumption \>14 drinks/week * BMI \>39 kg/m2 * use of glucocorticoids or drugs that affect glucocorticoid metabolism (e.g., ketoconazole) * severe osteopenia or osteoporosis, defined as femoral neck or lumbar spine t-score \<-2.0 * thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal thyroid stimulating hormone (TSH) values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement * liver dysfunction, defined as liver function tests (AST, ALT) \>1.5 times the upper limit of normal * uncontrolled hypertension defined as resting systolic BP \>150 mmHg or diastolic BP\>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the primary care provider (PCP) with initiation or adjustment of anti-hypertensive medications * self-reported history of breast cancer or other estrogen-dependent neoplasms * self-reported history of venous thromboembolism, pulmonary embolism, or other thromboembolic disorder * self-reported history of cardiovascular disease
Where this trial is running
Aurora, Colorado
- University of Colorado - Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Wendy M Kohrt, PhD — University of Colorado, Denver
- Study coordinator: Haley Thomas
- Email: haley.thomas@cuanschutz.edu
- Phone: 303-724-1407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.