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| ID | Type | Description | Link |
|---|---|---|---|
| MR-34-26-044995 | Other Identifier | Medical Research Registration and Filing Information System, China |
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| Name | Class |
|---|---|
| Zhejiang Nutriease Health Technology Co. Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-Assisted Intensive Lifestyle Intervention | Experimental | Participants in this arm will receive an AI-assisted intensive lifestyle intervention, including individualized dietary and lifestyle guidance supported by an AI-based platform and nutritionist follow-up, in addition to standardized lifestyle education. |
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| Tirzepatide Treatment | Active Comparator | Participants in this arm will receive tirzepatide treatment according to the study protocol, in addition to standardized lifestyle education. |
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| Standard Lifestyle Management | Active Comparator | Participants in this arm will receive standardized lifestyle management and health education according to the study protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-Assisted Intensive Lifestyle Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline to Week 52 | Change in glycated hemoglobin from baseline to week 52. | Baseline to Week 52 |
| Change in Fasting Plasma Glucose From Baseline to Week 52 | Change in fasting plasma glucose from baseline to week 52. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueying Zheng | Contact | +8619966188536 | lisazhengxy@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230022 | China |
Individual participant data will not be shared because of participant privacy protection, ethical restrictions, and institutional data governance requirements.
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Participants will be randomized in a 2:2:1 ratio to an AI-assisted intensive lifestyle intervention group, a tirzepatide treatment group, or a standard lifestyle management control group.
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| Tirzepatide | Drug | Tirzepatide will be administered by subcutaneous injection once weekly according to the protocol-defined dose titration and tolerability assessment. |
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| Standard Lifestyle Management | Behavioral | Standardized lifestyle management and health education, including general dietary, physical activity, and weight management advice according to the study protocol. |
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| Baseline to Week 52 |
| Change in Waist Circumference From Baseline to Week 52 | Change in waist circumference from baseline to week 52. | Baseline to Week 52 |
| Change in Body Mass Index From Baseline to Week 52 | Change in body mass index from baseline to week 52. | 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. | 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. | 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. | 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. | 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. | Baseline to Week 52 |
| Incidence of Adverse Events | The proportion of participants who experience at least one adverse event during the study period. | 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. | From enrollment to Week 64 |
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| 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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