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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
AI-assisted multi-domain lifestyle interventions that integrate dietary, physical activity, and psychological components.
Administered subcutaneously.
Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Body weight change (kg)
Weight will be measured to the nearest 0.1 kg
Time frame: Change from randomization (week 20) to week 72
Percent change in body weight
Percent change from week 20 to week 72
Time frame: Change from randomization (week 20) to week 72
Body mass index
Weight / Height\^2 (kg/m²)
Time frame: Change from randomization (week 20) to week 72
Waist and hip circumference
Waist and hip circumference will be measured to the nearest 0.1cm
Time frame: Change from randomization (week 20) to week 72
Body fat percentage
Change in body fat percentage (BF%) from randomization to the week 72
Time frame: 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
Time frame: Change from randomization (week 20) to week 72
Fat mass
Change in fat mass (FM) from randomization to the week 72, measured in kg
Time frame: 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
Time frame: 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)
Time frame: Change from randomization (week 20) to week 72
Concentration of glycated hemoglobin (HbA1c)
Concentration of HbA1c, measured in the percentage of hemoglobin
Time frame: Change from randomization (week 20) to week 72
Concentration of fasting glucose
Concentration of fasting glucose, measured in mmol/L
Time frame: Change from randomization (week 20) to week 72
Concentration of Insulin
Concentration of fasting insulin, measured in mU/L
Time frame: Change from randomization (week 20) to week 72
Concentration of C-peptide
Concentration of fasting C-peptide, measured in mmol/L
Time frame: 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
Time frame: Change from randomization (week 20) to week 72
Body weight change (kg)
Weight will be measured to the nearest 0.1 kg
Time frame: Change from baseline (week 0) to week 72
Percent change in body weight
* Percent change from week 0 to week 72 * Percentage of participants who achieve ≥5% body weight reduction * Percentage of participants who achieve ≥10% body weight reduction * Percentage of participants who achieve ≥15% body weight reduction
Time frame: Change from baseline (week 0) to week 72
Waist and hip circumference
Waist and hip circumference will be measured to the nearest 0.1cm
Time frame: Change from baseline (week 0) to week 72
Concentration of glycated hemoglobin (HbA1c)
Concentration of HbA1c, measured in the percentage of hemoglobin.
Time frame: 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
Time frame: Change from baseline (week 0) to week 72
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