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Study of Patients Being Treated With Anti-obesity Medication 100 Real-World Evidence Observational Lifestyle Exercise-Based

Recruiting
Clinical Trial NCT06790160 is an observational study for Obesity and Overweight that is recruiting. It started on January 31, 2025 with plans to enroll 100 participants. Led by Texas Tech University, it is expected to complete by February 1, 2027. The latest data from ClinicalTrials.gov was last updated on April 22, 2025.
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 exa...Show More
Detailed Description
Background. The popularity of anti-obesity medications, particularly glucagon-like peptide-1 receptor agonists (GLP-1RAs) like semaglutide and dual GLP-1/GIP receptor agonists like tirzepatide, has increased dramatically over the past several years. These medications are routinely prescribed in obesity management clinics and other medical settings. While controlled clinical trials have been conducted for specific dru...Show More
Official Title

Observational Study of Patients Being Treated With Anti-obesity Medication

Conditions
Obesity and Overweight
Other Study IDs
  • 2024-1109
NCT ID Number
Start Date (Actual)
2025-01-31
Last Update Posted
2025-04-22
Completion Date (Estimated)
2027-02
Enrollment (Estimated)
100
Study Type
Observational
Status
Recruiting
Keywords
obesity
GLP-1
body composition
nutrition
exercise
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in Total Body Mass
Change in total body 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 Total Body Fat Percentage
Change in total body fat percentage 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 Bone Mineral Content
Change in total bone mineral content 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 Visceral Fat
Change in visceral fat 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).
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
Texas Tech University logoTexas Tech University41 active studies to explore
Vineyard Health Inc. logoVineyard Health Inc.
Study Central Contact
Contact: Grant Tinsley, Ph.D., 806-834-5895, [email protected]
1 Study Locations in 1 Countries

Texas

Texas Tech University, Lubbock, Texas, 79409, United States
Grant Tinsley, Contact, 806-834-5895, [email protected]
Recruiting