Metabolic Disease, Obesity
Conditions
Keywords
Latinos, Obesity, Plant-forward diet, Tirzepatide
Brief summary
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.
Interventions
BEHAVIORALStandard Care
Participants will meet with community health workers to receive general health information through individual check-ins.
BEHAVIORALCulturally-tailored dietary and behavioral intensive lifestyle intervention
Participants will meet with community health workers to receive information focused on healthy eating while still adhering to a culturally-tailored plant-forward diet.
DRUGPlacebo
Participants will receive placebo subcutaneous injections.
DRUGTirzepatide
Participants will receive subcutaneous injections of tirzepatide that gradually increase up to 15 mg per week.
Sponsors
Eli Lilly and Company
National Institute on Minority Health and Health Disparities (NIMHD)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Self-reported Hispanic and/or Latino heritage * Body Mass Index (BMI) 30-42 kg/m² * HbA1c ≤ 6.4%
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | After 24 weeks of intervention | Percent change in body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants losing at least 10% in body weight | After 24 weeks of intervention | Proportion of participants in each group that lose at least 10% in body weight |
| Proportion of participants losing at least 15% in body weight | After 24 weeks of intervention | Proportion of participants in each group that lose at least 15% in body weight |
| Fat mass and fat free mass | Before and after 24 weeks of intervention | Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA) |
| β-cell function | Before and after 24 weeks of intervention | β-cell function will be assessed from a modified 3-hour oral glucose tolerance test |
| Insulin clearance | Before and after 24 weeks of intervention | Insulin clearance will be assessed from a modified 3-hour oral glucose tolerance test |
| Plasma lipids | Before and after 24 weeks of intervention | Fasting plasma lipid profile will be assessed by routine blood tests |
| Blood pressure | Before and after 24 weeks of intervention | Systolic and diastolic blood pressure will be measured |
| Sleep quality | Before and after 24 weeks of intervention | Sleep quality will be assessed by polysomnography. |
| Proportion of participants losing at least 5% in body weight | After 24 weeks of intervention | Proportion of participants in each group that lose at least 5% in body weight |
| Liver fat | Before and after 24 weeks of intervention | Liver fat will be assessed by using ultrasound |
| Intra-abdominal fat mass and intrahepatic triglyceride content | Before and after 52 weeks of intervention | Intra-abdominal fat mass and intrahepatic triglyceride content will be assessed via magnetic resonance imaging (MRI) |
| Physical performance | Before and after 24 weeks of intervention | Physical performance will be measured as the time in seconds that takes to walk 50 ft and to stand up 5 times from a chair. |
| Grip strength | Before and after 24 weeks of intervention | Grip strength will be measured using a hand dynamometer. |
| Lifestyle program adherence | After 24 weeks of intervention | Number of sessions attended |
| Drug/placebo adherence | After 24 weeks of intervention | Number of injections received |
| Program acceptability from community health workers and study participants | After 24 weeks of intervention | Community health workers' and study participants' perceptions of program acceptability via questionnaire |
| Sleep quantity | Before and after 24 weeks of intervention | Sleep quantity will be assessed by polysomnography. |
Countries
United States
Outcome results
None listed