Clinical trial NCT06790160: Study of Patients Being Treated With Anti-obesity Medication
Official title: Observational Study of Patients Being Treated With Anti-obesity Medication
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity and Overweight
Keywords: obesity
GLP-1
body composition
nutrition
exercise
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: Vineyard Health Inc.
First posted: 2025-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 drugs, many of these have not reported relevant outcomes, such as body composition changes, muscular performance, and nutritional intake. Additionally, these controlled clinical trials may not fully represent the "real world" effects of treatment in varied settings. As such, there is a need for observational, real-world evaluations of the effects of GLP-1RA and GLP-1/GIP drugs on body composition, muscular performance, nutritional intake, and routine clinical markers. Additionally, the influence of lifestyle factors, such as exercise participation, on the observed changes in these outcomes should be evaluated.

Overview. Eligible participants beginning treatment with selected obesity medications (semaglutide or tirzepatide) at a specified virtual health clinic 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.

Body Composition Assessment. Participants will be asked to report an approved local DXA testing facility for a baseline body composition assessment as close as possible to the beginning of their anti-obesity medication treatment. Participants will be requested to report for another scan after \~6 months of treatment, as well as after \~17 months of treatment (provided they are still undergoing treatment at this point).

Handgrip Strength Testing. Handgrip testing will take place using a standard, consumer-grade at-home handgrip dynamometer, which will be provided to each participant. Participants will be provided with instructions for conducting the handgrip testing. This testing will be completed at baseline (as close as possible to the initiation of anti-obesity medication), and after \~3, \~6, and \~17 months of treatment (provided they are still undergoing treatment at these time points).

Questionnaires. The following questionnaires will be completed at baseline (as close as possible to the initiation of anti-obesity medication), and after \~3, \~6, and \~17 months of treatment (provided they are still undergoing treatment at these time points):

1. Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool
2. The International Physical Activity Questionnaire (IPAQ)
3. The Muscle-Strengthening Exercise Questionnaire (MSEQ)

Standard Clinical Markers. Some clinical markers routinely collected during standard medical treatment will also be evaluated, including a lipid panel (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides), hemoglobin A1C, glucose, and blood pressure.

Power Analysis. A priori power analyses were conducted for repeated-measures ANOVA (within-subjects factors) using G\*Power to determine the required sample size. The analyses used a conservative effect size (f = 0.25; "medium" strength), an alpha error probability (α) of 0.05, a desired statistical power (1-β) of 0.8, and specified one group. Ranges of number of repeated measures (2 to 4), correlations between repeated measures (0.25 to 0.5), and nonsphericity corrections (ε; 0.8 to 1) were implemented. These analyses indicated the total sample size required to achieve adequate power ranged from 24 to 50 participants. A priori power analyses were conducted for linear multiple regression (R2 deviation from zero) using G\*Power to determine the required sample size for analyses examining predictors of variation in changes in outcome variables. A medium strength effect size (f2=0.15), an alpha error probability (α) of 0.05, and a desired statistical power (1-β) of 0.8 were specified. This analysis indicated that up to 6 predictors could be included in the regression model at a sample size of 98 participants. Based on consideration of these analyses, a target sample size of 100 was specified.

Statistical Analysis. Comprehensive descriptive data will be presented. Changes in all outcome variables over time will be quantified using appropriate statistical methods (e.g., repeated-measures ANOVA or a similar linear model). Additionally, the potential influence of lifestyle factors - particularly nutritional intake, physical activity level, and participation in muscle-strengthening activities - and medication type (semaglutide vs. tirzepatide) on outcome measures will be explored using an appropriate method (e.g., multiple linear regression or a related linear model, such as a linear mixed-effects model).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Total Lean Soft Tissue
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).
measure: Change in Appendicular Lean Soft Tissue
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).
measure: Change in Total Fat Mass
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).
measure: Change in Handgrip Strength
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).
Secondary outcomes:
measure: Change in Total Body Mass
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).
measure: Change in Total Body Fat Percentage
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).
measure: Change in Total Bone Mineral Content
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).
measure: Change in Visceral Fat
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).
Other outcomes:
measure: Change in Total Cholesterol
timeFrame: From baseline assessment to last available time point.
measure: Change in LDL Cholesterol
timeFrame: From baseline assessment to last available time point.
measure: Change in HDL Cholesterol
timeFrame: From baseline assessment to last available time point.
measure: Change in Triglycerides
timeFrame: From baseline assessment to last available time point.
measure: Change in Hemoglobin A1C
timeFrame: From baseline assessment to last available time point.
measure: Change in Glucose
timeFrame: From baseline assessment to last available time point.
measure: Change in Blood Pressure
timeFrame: From baseline assessment to last available time point.
measure: Energy Intake
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).
measure: Protein Intake
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).
measure: Carbohydrate Intake
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).
measure: Fat Intake
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).
measure: Fiber Intake
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).
measure: Sugar Intake
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).
measure: Muscle-strengthening activity level
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).
measure: Physical activity level
timeFrame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).
Locations:
city: Lubbock
country: United States
facility: Texas Tech University
state: Texas
Study officials:
References: