Study of Patients Being Treated With Anti-obesity Medication
ConditionObesity and Overweight
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTexas Tech University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population is eligible individuals who are undergoing standard obesity medication treatment at a specified virtual obesity medicine practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Patients undergoing obesity treatment
Trial outcomes
Primary outcomes
1
Change in Total Lean Soft Tissue
Change in total lean soft tissue assessed by dual-energy X-ray absorptiometry.
Time frame
From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).2
Change in Appendicular Lean Soft Tissue
Change in appendicular lean soft tissue assessed by dual-energy X-ray absorptiometry.
Time frame
From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).3
Change in Total Fat Mass
Change in total fat mass assessed by dual-energy X-ray absorptiometry.
Time frame
From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).4
Change in Handgrip Strength
Change in maximal handgrip strength as determined by a handgrip dynamometer.
Time frame
From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).Secondary outcomes
1
Change in Total Body Mass
Change in total body mass assessed by dual-energy X-ray absorptiometry.
Time frame
From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).2
Change in Total Body Fat Percentage
Change in total body fat percentage assessed by dual-energy X-ray absorptiometry.
Time frame
From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).3
Change in Total Bone Mineral Content
Change in total bone mineral content assessed by dual-energy X-ray absorptiometry.
Time frame
From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).4
Change in Visceral Fat
Change in visceral fat assessed by dual-energy X-ray absorptiometry.
Time frame
From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).Other outcomes
1
Change in Total Cholesterol
Change in total cholesterol as assessed by a lipid panel.
Time frame
From baseline assessment to last available time point.2
Change in LDL Cholesterol
Change in low-density lipoprotein cholesterol as assessed by a lipid panel.
Time frame
From baseline assessment to last available time point.3
Change in HDL Cholesterol
Change in high-density lipoprotein cholesterol as assessed by a lipid panel.
Time frame
From baseline assessment to last available time point.4
Change in Triglycerides
Change in triglycerides as assessed by a lipid panel.
Time frame
From baseline assessment to last available time point.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Texas Tech University
Lead sponsor
Vineyard Health Inc.
Collaborator
Source ClinicalTrials.gov