GLP-1RA Effects on Lean Mass and Bone Health in Midlife Women (GLOW)

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.

Study Overview

• Status: Recruiting
• Conditions: Body Composition; Muscle Function; GLP-1; Estrogen Level

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Johanna Finkle, MD; Phone Number: (913) 588-5478; Email: jfinkle2@kumc.edu
• Study Contact Backup: Name: Holly Hull, PhD; Phone Number: 913-945-5838; Email: hhull@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • The University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women in midlife who are establishing care at the KU OBGYN's weight management clinic

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
GLOW Participants; New patients, those who are newly prescribed a GLP-1RA medication will be invited to participate in the study where different measurements will be completed to assess body composition, hormone levels, muscle strength and nutrition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Assess changes in body weight by measuring weight on a calibrated scale	Baseline through 6-month visit
Body composition	Assess changes in lean and fat mass and fat-free mass in kilograms by total body DXA scan	Baseline through 6-month visit
Bone mineral density (BMD)	Assess changes in bone mineral density (BMD) by completing femur DXA scans	Baseline through 6-month visit
Muscle function	Assess muscle function changes in pounds by completing Grip strength tests	Baseline through 6-month visit
Muscle function	Assess changes to muscle function by the number of repetitions achieved per 30-second Sit-to-stand test	Baseline through 6-month visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline through 6-month visit
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.	Baseline through 6-month visit
Diet intake	Examine changes in dietary intake including protein consumption by collecting 24-hrs diet recalls.	Baseline through 6-month visit
Diet quality	Examine changes in dietary quality by collecting 24-hrs diet recalls.	Baseline through 6-month visit

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Johanna Finkle, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Women's health; Midlife; Dietary quality
• Other Study ID Numbers: STUDY00161780

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No