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NCT Number: NCT07422987

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

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.

Recruiting

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Key information

Conditions

Body Composition Estrogen Level GLP-1 Muscle Function

Age range

35 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Body weight

    Time frame: Baseline through 6-month visit

    Assess changes in body weight by measuring weight on a calibrated scale

  2. Body composition

    Time frame: Baseline through 6-month visit

    Assess changes in lean and fat mass and fat-free mass in kilograms by total body DXA scan

  3. Bone mineral density (BMD)

    Time frame: Baseline through 6-month visit

    Assess changes in bone mineral density (BMD) by completing femur DXA scans

  4. Muscle function

    Time frame: Baseline through 6-month visit

    Assess muscle function changes in pounds by completing Grip strength tests

  5. Muscle function

    Time frame: Baseline through 6-month visit

    Assess changes to muscle function by the number of repetitions achieved per 30-second Sit-to-stand test

Secondary outcomes

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

    Time frame: Baseline through 6-month visit

    Examine the moderating role of estrogen levels on changes in bone mineral density (BMD) during GLP-1RA therapy.

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

    Time frame: Baseline through 6-month visit

    Examine the moderating role of estrogen levels on changes in muscle function during GLP-1RA therapy.

  3. Diet intake

    Time frame: Baseline through 6-month visit

    Examine changes in dietary intake including protein consumption by collecting 24-hrs diet recalls.

  4. Diet quality

    Time frame: Baseline through 6-month visit

    Examine changes in dietary quality by collecting 24-hrs diet recalls.

Study contacts

Contact information is provided by the study sponsor or research team.

Holly Hull, PhD

CONTACT

[email protected]

913-945-5838

Johanna Finkle, MD

CONTACT

[email protected]

(913) 588-5478

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Acronym: GLOW

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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