Body Composition, Estrogen Level, GLP-1, Muscle Function
Conditions
Keywords
Midlife, Women's health, Dietary quality
Brief summary
This study is designed with the interest to learn on the effects of estrogen levels and how it affects body compositions and muscle function in midlife women who are taking a GLP-1RA for weight loss.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Females * Age 35-60 year * BMI≥30 or BMI≥27 and at least one cardiometabolic risk factor (dyslipidemia, hypertension, obstructive sleep apnea, metabolic syndrome, fatty liver, PCOS) * Newly prescribed a GLP-1RA medication * English speaking * Body weight stable for the past 6 months
Exclusion criteria
* Pregnant women * Under age 35 or over age 60 * Born male * Cannot consent for themselves * Cannot read and speak in English * Type 2 diabetes * Recently discontinued a GLP-1RA medication (less than 6-months since discontinuing) * Contraindications for taking a GLP-1 RA medication (personal or family history of medullary thyroid carcinoma, personal or family history of multiple endocrine neoplasia type 2, personal history of pancreatitis, pregnancy, hypersensitivity to the drug or any component of the drug, active suicidal ideation) * Currently taking aromatase inhibitors or selective estrogen receptor modulators (SERMs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | Baseline through 6-month visit | Assess changes in body weight by measuring weight on a calibrated scale |
| Body composition | Baseline through 6-month visit | Assess changes in lean and fat mass and fat-free mass in kilograms by total body DXA scan |
| Bone mineral density (BMD) | Baseline through 6-month visit | Assess changes in bone mineral density (BMD) by completing femur DXA scans |
| Muscle function | Baseline through 6-month visit | Assess muscle function changes in pounds by completing Grip strength tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estrogen level role in BMD changes during GLP-1RA therapy | Baseline through 6-month visit | Examine the moderating role of estrogen levels on changes in bone mineral density (BMD) during GLP-1RA therapy. |
| Estrogen level role in muscle function changes during GLP-1RA therapy | Baseline through 6-month visit | Examine the moderating role of estrogen levels on changes in muscle function during GLP-1RA therapy. |
| Diet intake | Baseline through 6-month visit | Examine changes in dietary intake including protein consumption by collecting 24-hrs diet recalls. |
| Diet quality | Baseline through 6-month visit | Examine changes in dietary quality by collecting 24-hrs diet recalls. |
Countries
United States
Contacts
University of Kansas Medical Center