Observational Study of Patients Being Treated With Anti-obesity Medication
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Total Lean Soft Tissue
研究概览
简要总结
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.
详细描述
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):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Change in Total Lean Soft Tissue
时间窗: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).
Change in total lean soft tissue assessed by dual-energy X-ray absorptiometry.
Change in Appendicular Lean Soft Tissue
时间窗: 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 assessed by dual-energy X-ray absorptiometry.
Change in Handgrip Strength
时间窗: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).
Change in maximal handgrip strength as determined by a handgrip dynamometer.
Change in Total Fat Mass
时间窗: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).
Change in total fat mass assessed by dual-energy X-ray absorptiometry.
次要结局
- 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).)