Effect of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
The purpose of this study is to conduct a three-arm 52-week, randomized controlled trial with double blind treatment to evaluate the effects of a drug called tirzepatide in combination with an innovative, culturally-appropriate, intensive lifestyle intervention (ILI) delivered by community health workers (CHWs) in Latino adults with obesity. Participants will be randomized to 1) standard care (SC, n=25); 2) culturally-tailored dietary and behavioral intensive lifestyle intervention (ILI, n=25) provided by CHWs plus placebo; or 3) ILI plus tirzepatide (ILI-TRZ) for 52 weeks to evaluate the intervention's effect on: i) weight loss; ii) clinical efficacy (change in body fat mass, liver fat, intra-abdominal fat mass and intrahepatic triglyceride content, oral glucose tolerance, glycemic control, insulin sensitivity and b-cell function, plasma lipids, blood pressure, sleep duration, quality and behaviors, physical performance scores); iii) adherence and fidelity to the intervention (adherence to the intervention and barriers to long term adherence, quality-of-life, fidelity of the implementation by CHWs, CHW's and study participants' acceptability and satisfaction with the intervention and eating behaviors. Placebo or tirzepatide will be injected subcutaneously in the abdomen or thigh once a week for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-reported Hispanic and/or Latino heritage
- •Body Mass Index (BMI) 30-42 kg/m²
- •HbA1c ≤ 6.4%
排除标准
- •Previous diagnosis of diabetes or fasting glucose ≥ 126 mg/dl or 2 hr oral glucose tolerance test plasma glucose ≥ 200 mg/dl
- •Unstable weight (≥4% during the last 2 months prior to study enrollment)
- •CPAP treatment for obstructive sleep apnea
- •Severe cardiovascular disease within the 6 months prior to study enrollment
- •Severe organ system dysfunction
- •Known clinically significant gastric emptying abnormality
- •History of chronic or acute pancreatitis
- •Thyroid-stimulating hormone (TSH) >1.5X the upper limit of normal
- •Medical conditions that cause obesity
- •History of significantly active or unstable Major Depressive Disorder or other severe psychiatric disorder within the last 2 months
- •Active substance abuse with alcohol or drugs
- •Uncontrolled hypertension
- •Liver disease
- •Calcitonin level of ≥20 ng/L if eGFR ≥60 mL/min/1.73 m2 or ≥35 ng/L if eGFR <60 mL/min/1.73 m2
- •Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- •History of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
- •Severe anemia
- •Pregnant or breastfeeding
- •Metal implants that preclude MRI testing
- •Use of medications that are known to affect the study outcome measures
- •Do not agree to use contraception throughout the study period in male and female participants of reproductive and childbearing age
- •Persons who are not able to grant voluntary informed consent
- •Unable or unwilling to follow the study protocol
- •Have any other condition not listed in this section (e.g. hypersensitivity or intolerance) that is a contraindication of GLP-1R agonists
研究组 & 干预措施
Standard Care
In this arm, participants will receive the standard care intervention from community health workers.
干预措施: Standard Care (Behavioral)
Intensive lifestyle intervention plus placebo
In this arm, participants will receive a culturally-tailored dietary and behavioral intensive lifestyle intervention from community health workers, and will receive placebo subcutaneous injections weekly during the 52-week intervention.
干预措施: Culturally-tailored dietary and behavioral intensive lifestyle intervention (Behavioral)
Intensive lifestyle intervention plus placebo
In this arm, participants will receive a culturally-tailored dietary and behavioral intensive lifestyle intervention from community health workers, and will receive placebo subcutaneous injections weekly during the 52-week intervention.
干预措施: Placebo (Drug)
Intensive lifestyle intervention plus tirzepatide
In this arm, participants will receive the behavioral plant-based intervention from community health workers, and will receive subcutaneous injections of tirzepatide weekly during the 52-week intervention
干预措施: Culturally-tailored dietary and behavioral intensive lifestyle intervention (Behavioral)
Intensive lifestyle intervention plus tirzepatide
In this arm, participants will receive the behavioral plant-based intervention from community health workers, and will receive subcutaneous injections of tirzepatide weekly during the 52-week intervention
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Change in body weight
时间窗: After 52 weeks of intervention
Percent change in body weight
次要结局
- Sleep quantity(Before and after 52 weeks of intervention)
- Proportion of participants losing at least 10% in body weight(After 52 weeks of intervention)
- Proportion of participants losing at least 5% in body weight(After 52 weeks of intervention)
- Plasma lipids(Before and after 52 weeks of intervention)
- Proportion of participants losing at least 15% in body weight(After 52 weeks of intervention)
- Intra-abdominal fat mass and intrahepatic triglyceride content(Before and after 52 weeks of intervention)
- Physical performance(Before and after 52 weeks of intervention)
- Fat mass and fat free mass(Before and after 52 weeks of intervention)
- Liver fat(Before and after 52 weeks of intervention)
- Grip strength(Before and after 52 weeks of intervention)
- β-cell function(Before and after 52 weeks of intervention)
- Insulin clearance(Before and after 52 weeks of intervention)
- Sleep quality(Before and after 52 weeks of intervention)
- Blood pressure(Before and after 52 weeks of intervention)
- Lifestyle program adherence(After 52 weeks of intervention)
- Drug/placebo adherence(After 52 weeks of intervention)
- Program acceptability from community health workers and study participants(After 52 weeks of intervention)