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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
285
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.
Tirzepatide will be administered by subcutaneous injection once weekly according to the protocol-defined dose titration and tolerability assessment.
Standardized lifestyle management and health education, including general dietary, physical activity, and weight management advice according to the study protocol.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Percent Change in Body Weight From Baseline to Week 52
Percent change in body weight from baseline to week 52 will be calculated as \[(body weight at week 52 - body weight at baseline) / body weight at baseline\] × 100%. A negative value indicates weight loss.
Time frame: Baseline to Week 52
Change in HbA1c From Baseline to Week 52
Change in glycated hemoglobin from baseline to week 52.
Time frame: Baseline to Week 52
Change in Fasting Plasma Glucose From Baseline to Week 52
Change in fasting plasma glucose from baseline to week 52.
Time frame: Baseline to Week 52
Change in Waist Circumference From Baseline to Week 52
Change in waist circumference from baseline to week 52.
Time frame: Baseline to Week 52
Change in Body Mass Index From Baseline to Week 52
Change in body mass index from baseline to week 52.
Time frame: Baseline to Week 52
Proportion of Participants Achieving Type 2 Diabetes Remission at Week 64
Type 2 diabetes remission is defined as HbA1c \<6.5% at week 64 without the use of glucose-lowering medications for at least 3 months before the assessment. Participants who receive rescue glucose-lowering therapy before week 64 will be considered not achieving remission.
Time frame: Week 64
Change in CGM Time in Range From Baseline to Week 52
Change in the percentage of continuous glucose monitoring time with glucose values between 3.9 and 10.0 mmol/L from baseline to week 52.
Time frame: Baseline to Week 52
Change in CGM Time Above Range From Baseline to Week 52
Change in the percentage of continuous glucose monitoring time with glucose values above 10.0 mmol/L from baseline to week 52.
Time frame: Baseline to Week 52
Change in CGM Time Below Range From Baseline to Week 52
Change in the percentage of continuous glucose monitoring time with glucose values below 3.9 mmol/L from baseline to week 52.
Time frame: Baseline to Week 52
Change in CGM Coefficient of Variation From Baseline to Week 52
Change in the coefficient of variation of continuous glucose monitoring glucose values from baseline to week 52. The coefficient of variation will be expressed as a percentage.
Time frame: Baseline to Week 52
Incidence of Adverse Events
The proportion of participants who experience at least one adverse event during the study period.
Time frame: From enrollment to Week 64
Incidence of Serious Adverse Events
The proportion of participants who experience at least one serious adverse event during the study period.
Time frame: From enrollment to Week 64
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