overweight or obesity with type 2 diabetes mellitus
Conditions
Interventions
Control group:Continued treatment with weekly subcutaneous 5.0mg tirzepatide
Intervention group:AI-assisted multi-domain lifestyle intervention
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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/m^2; 3.Type 2 diabetes mellitus diagnosed by physicians based on the World Health Organization (WHO) 1999 criteria within the past 5 years prior to screening; 4.Able and willing to participate voluntarily, maintain effective communications with investigator, comply with the trial protocol procedures, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.History of type 1 diabetes mellitus or type 2 diabetes mellitus with insulin therapy, or other types of diabetes; 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 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 evaluations at screening meet any of the following criteria: Calcitonin >=50 pg/mL; Thyroid stimulating hormone (TSH) >6.0 or 2.5 × upper limit of normal (ULN) or total bilirubin (TBiL) >2.5 × ULN (except Gilbert’s syndrome with conjugated bilirubin =5.7 mmol/L;Serum amylase >2.5 × ULN; eGFR <30 mL/min/1.73m^2. 14.History of uncontrolled and potentially unstable proliferative retinopathy or maculopathy, or history of diabetic ketoacidosis, diabetic non-ketotic hyperosmolar coma, or severe metabolic disturbances with neurological and psychiatric disorders within 1 year prior to screening; 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.Planning to become pregnant within the next two years, or currently pregnant or lactating women; 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 |
|---|---|
| Weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin;Fasting glucose;Insulin;C-peptide;Total cholesterol;Triglycerides;Low-density lipoprotein cholesterol;High density lipoprotein cholesterol;High-sensitivity C-reactive protein;HOMA-IR;HOMA-ß;Visceral fat;Liver stiffness measurement;Controlled attenuation parameter;Blood pressure;Waist circumference;Hip circumference;Body mass index;Body composition;Gut microbiota;Metabolomics; | — |
Countries
China
Contacts
Public ContactTianshu Zeng
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed