Status:
COMPLETED
Metabolic Effects of Perimenopause
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
American Diabetes Association
Conditions:
Perimenopausal Disorder
Eligibility:
FEMALE
38-60 years
Phase:
NA
Brief Summary
Starting in early-perimenopause, changes in systemic and tissue level metabolism result in an accelerated loss of muscle mass and an increase in body fat. Our preliminary work indicates that metabolic...
Eligibility Criteria
Inclusion
- Early and late perimenopausal women (≥38 years; early: experienced menstrual bleeding in the previous 3 months with a decrease in cycle regularity in the past year; late: no menstrual bleeding in the previous 3 months with some bleeding in the previous year).
- Overweight and obese: body mass index (BMI) of 28 - 40 Kg/m\^2 and percent body fat (%BF) ≥ 30%.
- Healthy, non-smokers.
Exclusion
- Have current and/or history of cardiovascular disease, diabetes, metabolic, thyroid, pulmonary, renal, hepatic, gastrointestinal, musculoskeletal disorders or medical or surgical events, such as bariatric surgery, heart surgery, or any joint or musculoskeletal injuries or surgeries occurring in the 6-months prior to enrollment, that may significantly influence study outcomes or prevent safe participation.
- Gained or lost \>5 kg in the previous 2 months
- Have a self-identified or clinically diagnosed eating disorder
- Undergone a full or partial hysterectomy for treatment of menopausal symptoms
- Have uncontrolled hypertension or an abnormal electrocardiogram.
- Have an ongoing diagnosed mental disorder with a change in medication in the previous 6 months.
- Taking metabolism-altering drugs or medications outside of estrogen replacement therapy that may influence study outcomes (i.e. corticosteroids, stimulants, insulin, thyroid medications) or phytoestrogens.
- Diagnosed with polycystic ovarian syndrome (PCOS).
- Participating in more than 75 minutes per week of moderate exercise per week.
- Currently pregnant or planning to become pregnant (determined from urine pregnancy test)
- Currently nursing or have had a child within the previous 6 months
- Has participated in another clinical trial within four weeks prior to enrollment that in the opinion of the PI would influence the results.
- Has severely impaired hearing or speech or inability to speak English.
- Unwilling or unable to comply with the study protocol, including abstaining from caffeine, tobacco, alcohol, and physical activity before testing days.
Key Trial Info
Start Date :
March 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06098183
Start Date
March 22 2024
End Date
August 8 2025
Last Update
September 11 2025
Active Locations (1)
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1
Applied Physiology Laboratory - University of North Carolina
Chapel Hill, North Carolina, United States, 27599