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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI assisted multi-domain lifestyle intervention | Experimental | Participants will be randomized to receive multi-domain lifestyle intervention including diet, physical activity and psychological support for 52 weeks. Additionally, the weight loss maintenance program will integrate AI-assisted nutritional analysis to facilitate long-term weight management. |
|
| Tirzepatide | Active Comparator | Participants will be randomized to receive tirzepatide 5 mg treatment for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI assisted multi-domain lifestyle intervention | Behavioral | AI-assisted multi-domain lifestyle interventions that integrate dietary, physical activity, and psychological components. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight change (kg) | Weight will be measured to the nearest 0.1 kg | Change from randomization (week 20) to week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in body weight | Percent change from week 20 to week 72 | Change from randomization (week 20) to week 72 |
| Body mass index | Weight / Height^2 (kg/m²) |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of high-sensitivity C-reactive protein (hs-CRP) | Concentration of hs-CRP, measured in mU/L | Change from baseline (week 0) to week 72 |
| HOMA-IR | Fasting insulin (μU/mL) * fasting glucose (mmol/L) / 22.5 |
Inclusion Criteria:
Exclusion Criteria:
History of type 1 diabetes mellitus or other types of diabetes, or treatment with insulin.
History of obesity attributable to endocrine disorders or monogenic mutations.
A self-reported change in body weight ≥5.0% within 3 months prior to the day of screening.
Use of medications or products causing weight changes or affecting weight assessment within 3 months prior to the day of screening;
History of major adverse cardiovascular or cerebrovascular events within 6 months before screening (e.g., angina, myocardial infarction, arrhythmia, stroke, intracranial hemorrhage).
History of acute or chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis.
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).
History of organ transplantation, congenital or acquired immunodeficiency disorders.
History of schizophrenia or major depressive disorder or other severe psychiatric disorders.
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).
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.
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.
Laboratory evaluation at screening meet any of the following criteria:
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.
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).
Patients with active bacterial, viral, or fungal infections requiring hospitalization or antibiotic treatment.
History of infectious diseases such as human immunodeficiency virus (HIV), syphilis, or active hepatitis.
Female patients who are pregnant, lactating, or planning to become pregnant within the next two years.
Participation in other clinical trial within 3 months before screening or currently enrolled in other clinical trial study.
History of drug abuse or alcohol dependence within 6 months before screening.
Any other reasons that researchers deem to unsuitable for participation in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Liu, PHD | Contact | 86-15926238366 | liugang026@hust.edu.cn | |
| Zijun Tang | Contact | 86-13037181387 | tangzj_2024@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China |
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| Tirzepatide | Drug | Administered subcutaneously. |
|
| Change from randomization (week 20) to week 72 |
| Waist and hip circumference | Waist and hip circumference will be measured to the nearest 0.1cm | Change from randomization (week 20) to week 72 |
| Body fat percentage | Change in body fat percentage (BF%) from randomization to the week 72 | Change from randomization (week 20) to week 72 |
| Skeletal muscle mass | Change in skeletal muscle mass (SMM) from randomization to the week 72, measured in kg | Change from randomization (week 20) to week 72 |
| Fat mass | Change in fat mass (FM) from randomization to the week 72, measured in kg | Change from randomization (week 20) to week 72 |
| Fat free mass | Change in fat free mass (FFM) from randomization to the week 72, measured in kg | Change from randomization (week 20) to week 72 |
| Blood pressure | Blood pressure (systolic/diastolic) will be measured with a digital blood pressure monitor in sitting position (mmHg) | Change from randomization (week 20) to week 72 |
| Concentration of glycated hemoglobin (HbA1c) | Concentration of HbA1c, measured in the percentage of hemoglobin | Change from randomization (week 20) to week 72 |
| Concentration of fasting glucose | Concentration of fasting glucose, measured in mmol/L | Change from randomization (week 20) to week 72 |
| Concentration of Insulin | Concentration of fasting insulin, measured in mU/L | Change from randomization (week 20) to week 72 |
| Concentration of C-peptide | Concentration of fasting C-peptide, measured in mmol/L | Change from randomization (week 20) to week 72 |
| Concentration of blood lipids | Concentration of blood lipids (total cholesterol, triglycerides, low-density lipoprotein cholesterol, high density lipoprotein cholesterol), measured in mmol/L | Change from randomization (week 20) to week 72 |
| Body weight change (kg) | Weight will be measured to the nearest 0.1 kg | Change from baseline (week 0) to week 72 |
| Percent change in body weight |
| Change from baseline (week 0) to week 72 |
| Waist and hip circumference | Waist and hip circumference will be measured to the nearest 0.1cm | Change from baseline (week 0) to week 72 |
| Concentration of glycated hemoglobin (HbA1c) | Concentration of HbA1c, measured in the percentage of hemoglobin. | Change from baseline (week 0) to week 72 |
| Concentration of blood lipids | Concentration of blood lipids (total cholesterol, triglycerides, low-density lipoprotein cholesterol, high density lipoprotein cholesterol), measured in mmol/L | Change from baseline (week 0) to week 72 |
| Change from baseline (week 0) to week 72 |
| HOMA-β | 20*Fasting insulin(μU/mL)／[fasting glucose (mmol／L)-3.5] | Change from baseline (week 0) to week 72 |
| Visceral fat | MRI will be performed to measure liver and pancreatic fat | Change from baseline (week 0) to week 72 |
| Liver stiffness measurement | Transient elastography will be performed to measure liver stiffness measurement (kPa). | Change from baseline (week 0) to week 72 |
| Controlled attenuation parameter | Transient elastography will be performed to measure controlled attenuation parameter (dB/m) | Change from baseline (week 0) to week 72 |
| Metagenomic analysis of the gut microbiota | The diversity of the gut microbiota will be assessed by whole-metagenomic sequencing | Change from baseline (week 0) to week 72 |
| Liver function | Concentration of fasting Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) | Change from baseline (week 0) to week 72 |
| Concentration of serum creatinine | Concentration of serum creatinine, measured in μmol/L | Change from baseline (week 0) to week 72 |
| Concentration of serum Cystatin C | Concentration of serum Cystatin C, measured in mg/L | Change from baseline (week 0) to week 72 |
| Concentration of serum uric | Concentration of serum uric, measured in μmol/L | Change from baseline (week 0) to week 72 |
| Estimated glomerular filtration rate | Estimated glomerular filtration rate (eGFR) was calculated using the MDRD equation, reported in mL/min/1.73 m² | Change from baseline (week 0) to week 72 |
| Number of adverse events | N, frequency | Change from baseline (week 0) to week 72 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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