Overweight or Obesity; Type 2 Diabetes, Weight Loss Maintenance
Conditions
Brief summary
This is a randomized controlled trial to compare the effect of AI-assisted multi-domain lifestyle and continued tirzepatide on body weight loss maintenance. The study consists of two phases: a 20-week lead-in phase, during which all participants will receive weekly subcutaneous tirzepatide at the maximum tolerated dose (MTD), followed by a 52-week intervention phase. Participants who meet the randomization criteria after the lead-in phase will be randomly assigned to either AI-assisted multi-domain lifestyle intervention or tirzepatide 5 mg
Detailed description
Diabetes and obesity have emerged as critical public health problems in China. Notably, more than half of Chinese adults with diabetes are concurrently with overweight or obesity. Weight management is a cornerstone of type 2 diabetes treatment, with robust evidence showing that weight loss improves glycemic control, blood pressure, lipid profiles, and may facilitate diabetes remission. However, maintaining long-term weight loss remains a formidable clinical challenge. Current clinical guidelines recommend several maintenance strategies after achieving target weight loss, including continued use of anti-obesity medications (AOMs), dose reduction, or structured lifestyle interventions. Few studies have suggested that compared with continued tirzepatide treatment, switching to placebo resulted in significant weight regain. However, important knowledge gaps remain regarding the effectiveness of AI-assisted multi-domain lifestyle interventions that integrate dietary, physical activity, and psychological components compared with reduced dose of tirzepatide treatment on weight loss maintenance in patients with type 2 diabetes. This study aims to investigate the effect of AI-assisted multi-domain lifestyle interventions on weight loss maintenance in overweight or obese patients with type 2 diabetes, compared with tirzepatide treatment.
Interventions
BEHAVIORALAI assisted multi-domain lifestyle intervention
AI-assisted multi-domain lifestyle interventions that integrate dietary, physical activity, and psychological components.
DRUGTirzepatide
Administered subcutaneously.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female participants aged 18 to 65 years at the time of signing informed consent; 2. Body Mass Index (BMI) ≥27.0 kg/m²; 3. Type 2 diabetes mellitus diagnosed by physicians within the past 5 years prior to screening. 4. Voluntary participation and provide written informed consent.
Exclusion criteria
1. History of type 1 diabetes mellitus or other types of diabetes, or treatment with insulin. 2. History of obesity attributable to endocrine disorders or monogenic mutations. 3. A self-reported change in body weight ≥5.0% within 3 months prior to the day of screening. 4. Use of medications or products causing weight changes or affecting weight assessment within 3 months prior to the day of screening; 5. History of major adverse cardiovascular or cerebrovascular events within 6 months before screening (e.g., angina, myocardial infarction, arrhythmia, stroke, intracranial hemorrhage). 6. History of acute or chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis. 7. History of cancers (except for localized basal cell carcinoma, adenocarcinoma in situ of cervix or prostate carcinoma in situ); personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia syndrome (MEN2), or history of thyroid nodules (category IV or higher). 8. History of organ transplantation, congenital or acquired immunodeficiency disorders. 9. History of schizophrenia or major depressive disorder or other severe psychiatric disorders. 10. Poorly controlled hypertension at screening (systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg despite at least 4 weeks of conventional antihypertensive therapy). 11. History of clinically significant gastric emptying abnormalities, or history of severe chronic gastrointestinal disease, or history of diabetic gastroparesis, or long-term use of drugs that directly affect gastrointestinal motility, or history of gastrointestinal surgery. 12. Those who are known to be allergic to any component of GLP-1 receptor agonists drugs, or have more than two allergies, or be allergic to soy, dairy, or similar foods. 13. Laboratory evaluation at screening meet any of the following criteria: * Calcitonin ≥50 pg/mL; * Thyroid stimulating hormone (TSH) \>6.0 or \<0.4 mIU/L; * Fasting C-peptide \<0.81 ng/mL; * Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>2.5 × upper limit of normal (ULN) or total bilirubin (TBIL) \>2.5 × ULN (except Gilbert's syndrome with conjugated bilirubin \<35%); * Triglycerides ≥5.7 mmol/L; * Serum amylase \>2.5 × ULN; * eGFR \<30 mL/min/1.73m² 14. History of uncontrolled and potentially unstable proliferative retinopathy or maculopathy within 1 year prior to screening, or history of diabetic ketoacidosis, diabetic non-ketotic hyperosmolar coma, or severe metabolic disturbances with neurological and psychiatric disorders. 15. History of clinically significant anemia, or epilepsy, or syncope or cardiac conditions (e.g. cardiac arrest, arrhythmias, atrioventricular block, structural heart disease, torsades de pointes). 16. Patients with active bacterial, viral, or fungal infections requiring hospitalization or antibiotic treatment. 17. History of infectious diseases such as human immunodeficiency virus (HIV), syphilis, or active hepatitis. 18. Female patients who are pregnant, lactating, or planning to become pregnant within the next two years. 19. Participation in other clinical trial within 3 months before screening or currently enrolled in other clinical trial study. 20. History of drug abuse or alcohol dependence within 6 months before screening. 21. Any other reasons that researchers deem to unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight change (kg) | Change from randomization (week 20) to week 72 | Weight will be measured to the nearest 0.1 kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in body weight | Change from randomization (week 20) to week 72 | Percent change from week 20 to week 72 |
| Body mass index | Change from randomization (week 20) to week 72 | Weight / Height\^2 (kg/m²) |
| Waist and hip circumference | Change from randomization (week 20) to week 72 | Waist and hip circumference will be measured to the nearest 0.1cm |
| Body fat percentage | Change from randomization (week 20) to week 72 | Change in body fat percentage (BF%) from randomization to the week 72 |
| Skeletal muscle mass | Change from randomization (week 20) to week 72 | Change in skeletal muscle mass (SMM) from randomization to the week 72, measured in kg |
| Fat mass | Change from randomization (week 20) to week 72 | Change in fat mass (FM) from randomization to the week 72, measured in kg |
| Fat free mass | Change from randomization (week 20) to week 72 | Change in fat free mass (FFM) from randomization to the week 72, measured in kg |
| Blood pressure | Change from randomization (week 20) to week 72 | Blood pressure (systolic/diastolic) will be measured with a digital blood pressure monitor in sitting position (mmHg) |
| Concentration of glycated hemoglobin (HbA1c) | Change from randomization (week 20) to week 72 | Concentration of HbA1c, measured in the percentage of hemoglobin |
| Concentration of fasting glucose | Change from randomization (week 20) to week 72 | Concentration of fasting glucose, measured in mmol/L |
| Concentration of Insulin | Change from randomization (week 20) to week 72 | Concentration of fasting insulin, measured in mU/L |
| Concentration of C-peptide | Change from randomization (week 20) to week 72 | Concentration of fasting C-peptide, measured in mmol/L |
| Concentration of blood lipids | Change from randomization (week 20) to week 72 | Concentration of blood lipids (total cholesterol, triglycerides, low-density lipoprotein cholesterol, high density lipoprotein cholesterol), measured in mmol/L |
| Body weight change (kg) | Change from baseline (week 0) to week 72 | Weight will be measured to the nearest 0.1 kg |
Countries
China
Contacts
CONTACTGang Liu, PHD
CONTACTZijun Tang
Outcome results
None listed