RECRUITING

Bioenergetic Effects of Aging and Menopause (BEAM)

Conditions

Menopause Obesity, Abdominal Aging Weight Gain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The menopause transition is associated with increased risk for weight gain and a shift toward storing fat in the belly region, which may increase risk for cardiovascular disease and diabetes. The study will determine whether the stress hormone cortisol contributes to this shift.

Official Title

Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women - 2018

Quick Facts

Study Start:2019-09-24

Study Completion:2024-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04043520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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

Contacts and Locations

Study Contact

Haley Thomas

CONTACT

303-724-1407

haley.thomas@cuanschutz.edu

Principal Investigator

Wendy M Kohrt, PhD

PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Study Locations (Sites)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Wendy M Kohrt, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-24

Study Completion Date2024-08-31

Study Record Updates

Study Start Date2019-09-24

Study Completion Date2024-08-31

Terms related to this study

Additional Relevant MeSH Terms

Menopause
Obesity, Abdominal
Aging
Weight Gain