AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes
This multicenter randomized controlled trial will evaluate whether an AI-assisted intensive lifestyle intervention can improve weight and glycemic management in adults with obesity and newly diagnosed type 2 diabetes, compared with tirzepatide treatment and standard lifestyle management. Eligible participants will be adults aged 18 to 65 years with a body mass index of 28 to less than 40 kg/m² and newly diagnosed type 2 diabetes who have not used glucose-lowering medications in the past 3 months. Participants…
Conditions studied
Obesity, Diabetes Mellitus, Type 2
About this study
This multicenter randomized controlled trial will evaluate whether an AI-assisted intensive lifestyle intervention can improve weight and glycemic management in adults with obesity and newly diagnosed type 2 diabetes, compared with tirzepatide treatment and standard lifestyle management. Eligible participants will be adults aged 18 to 65 years with a body mass index of 28 to less than 40 kg/m² and newly diagnosed type 2 diabetes who have not used glucose-lowering medications in the past 3 months. Participants will be randomly assigned to one of three groups: an AI-assisted intensive lifestyle intervention group, a tirzepatide treatment group, or a standard lifestyle management control group. The intervention period will last 52 weeks, followed by a 12-week post-intervention follow-up period. The main outcome is the percentage change in body weight at week 52. The study will also assess glycemic control, body composition, continuous glucose monitoring metrics, safety, and other metabolic outcomes.
Interventions
- Behavioral: AI-Assisted Intensive Lifestyle Intervention — An intensive lifestyle intervention supported by an AI-based platform and nutritionist follow-up, including individualized dietary guidance, lifestyle behavior support, and weight management counseling.
- Drug: Tirzepatide — Tirzepatide will be administered by subcutaneous injection once weekly according to the protocol-defined dose titration and tolerability assessment.
- Behavioral: Standard Lifestyle Management — Standardized lifestyle management and health education, including general dietary, physical activity, and weight management advice according to the study protocol.
Primary outcomes
- Percent Change in Body Weight From Baseline to Week 52 (Baseline to Week 52)
Eligibility information
Study locations
- The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230022 China
- The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230601 China
- First Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001 China
- The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000 China
- The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016 China
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-15.