Study of Patients Being Treated With Anti-obesity Medication

NCT06790160 | Recruiting

• 1 other identifier: 2024-1109
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the real-world effects of selected obesity medications in adults undergoing medical weight management. The main outcomes of interest are changes in body composition, routine clinical markers, muscular performance, and nutritional intake over the course of treatment. Additionally, the influence of lifestyle factors on changes in these outcome variables will be examined. Participants beginning treatment with selected obesity medications will undergo periodic body composition and muscular performance testing, as well as complete online surveys about their nutritional intake and physical activity and exercise participation. Additionally, routinely collected clinical information will be evaluated.

Conditions

Obesity and Overweight

Keywords

obesity; GLP-1; body composition; nutrition; exercise

Outcome Measures

Primary Outcomes (4)

• Change in Total Lean Soft Tissue

  Change in total lean soft tissue assessed by dual-energy X-ray absorptiometry.

  From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

• Change in Appendicular Lean Soft Tissue

  Change in appendicular lean soft tissue assessed by dual-energy X-ray absorptiometry.

  From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

• Change in Total Fat Mass

  Change in total fat mass assessed by dual-energy X-ray absorptiometry.

  From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

• Change in Handgrip Strength

  Change in maximal handgrip strength as determined by a handgrip dynamometer.

  From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).

Secondary Outcomes (4)

• Change in Total Body Mass

  From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

• Change in Total Body Fat Percentage

  From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

• Change in Total Bone Mineral Content

  From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

• Change in Visceral Fat

  From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

Other Outcomes (15)

• Change in Total Cholesterol

  From baseline assessment to last available time point.

• Change in LDL Cholesterol

  From baseline assessment to last available time point.

• Change in HDL Cholesterol

  From baseline assessment to last available time point.

Study Arms (1)

Patients undergoing obesity treatment

This cohort will be comprised of individuals who are beginning obesity medication treatment at a specified virtual obesity medicine practice. Patients taking semaglutide or tirzepatide may be eligible for inclusion in this cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is eligible individuals who are undergoing standard obesity medication treatment at a specified virtual obesity medicine practice.

You may qualify if:

• Patient who is beginning treatment through Vineyard Virtual Health Clinic using semaglutide or tirzepatide. While the physician will individualize the treatment plans, the criteria for these medications will include, at a minimum: (A) a body mass index ≥30 kg/m2; OR (B) a BMI ≥27 kg/m2 plus at least one comorbidity.
• Patient who lives in drivable proximity to a city with an accepted DXA testing facility and is willing to report to the facility for periodic body composition testing.

You may not qualify if:

• Patients with type 2 diabetes.
• Patients who report not being willing or able to complete the assessments included in this research study.
• Patients who are currently pregnant or trying to become pregnant.

Sponsors & Collaborators

• Texas Tech University: lead
• Vineyard Health Inc.: collaborator

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79409, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Grant Tinsley, Ph.D.

CONTACT

806-834-5895; grant.tinsley@ttu.edu

Study Design

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

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: January 31, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)