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

NCT07422987 | Recruiting

• 1 other identifier: STUDY00161780
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Composition; Muscle Function; GLP-1; Estrogen Level

Keywords

Midlife; Women's health; Dietary quality

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Estrogen level role in BMD changes during GLP-1RA therapy

  Baseline through 6-month visit

• Estrogen level role in muscle function changes during GLP-1RA therapy

  Baseline through 6-month visit

• Diet intake

  Baseline through 6-month visit

• Diet quality

  Baseline through 6-month visit

Study Arms (1)

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.

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Study Officials

• Johanna Finkle, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Finkle, MD

CONTACT

(913) 588-5478; jfinkle2@kumc.edu

Holly Hull, PhD

CONTACT

913-945-5838; hhull@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 20, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (1)