GLP-1RA Effects on Lean Mass and Bone Health in Midlife Women
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age35-60
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Pregnant women
Under age 35 or over age 60
Born male
Cannot consent for themselves
Trial population
Women in midlife who are establishing care at the KU OBGYN's weight management clinic
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: GLOW Participants
Trial outcomes
Primary outcomes
1
Body weight
Assess changes in body weight by measuring weight on a calibrated scale
Time frame
Baseline through 6-month visit2
Body composition
Assess changes in lean and fat mass and fat-free mass in kilograms by total body DXA scan
Time frame
Baseline through 6-month visit3
Bone mineral density (BMD)
Assess changes in bone mineral density (BMD) by completing femur DXA scans
Time frame
Baseline through 6-month visit4
Muscle function
Assess muscle function changes in pounds by completing Grip strength tests
Time frame
Baseline through 6-month visitSecondary outcomes
1
Estrogen level role in BMD changes during GLP-1RA therapy
Examine the moderating role of estrogen levels on changes in bone mineral density (BMD) during GLP-1RA therapy.
Time frame
Baseline through 6-month visit2
Estrogen level role in muscle function changes during GLP-1RA therapy
Examine the moderating role of estrogen levels on changes in muscle function during GLP-1RA therapy.
Time frame
Baseline through 6-month visit3
Diet intake
Examine changes in dietary intake including protein consumption by collecting 24-hrs diet recalls.
Time frame
Baseline through 6-month visit4
Diet quality
Examine changes in dietary quality by collecting 24-hrs diet recalls.
Time frame
Baseline through 6-month visitSponsors and contacts
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Source ClinicalTrials.gov