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To evaluate the effects of subcutaneous injection of semaglutide for 12 weeks on patients with type 2 diabetes mellitus (T2DM), compared with concurrent energy-restricted management, on glycemic control, weight loss, inflammatory markers, liver fat content, and other parameters. The study also observed the subcutaneous and visceral fat of the participants and explored the molecular mechanisms of action, providing high-quality evidence-based support for the timing and targets of intervention in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| semaglutide group | Experimental | The semaglutide group received weekly subcutaneous semaglutide (0.25 mg for weeks 1-2, 0.5 mg for weeks 3-4, and 1.0 mg for weeks 5-12). |
|
| caloric restriction group | Active Comparator | The caloric restriction group followed a gender-specific daily caloric restriction (1,500-1,800 kcal for males; 1,200-1,500 kcal for females). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | The semaglutide group received weekly subcutaneous semaglutide (0.25 mg for weeks 1-2, 0.5 mg for weeks 3-4, and 1.0 mg for weeks 5-12). |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | glycated hemoglobin | From enrollment to the end of treatment at 12 weeks |
| FPG | fasting plasma glucose | From enrollment to the end of treatment at 12 weeks |
| 2hPG | 2-hour postprandial glucose | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HOMA-IR | homeostasis model assessment of insulin resistance | From enrollment to the end of treatment at 12 weeks |
| TC | total cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianping Liu | Contact | +8679186274551 | ndefy14105@ncu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minde road No.1 | Recruiting | Jiangxi | Nanchang | 330000 | China |
Some of the data involves patient privacy. If there is a need to share the data, please contact the relevant researchers of this project.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| caloric restriction | Behavioral | The caloric restriction group followed a gender-specific daily caloric restriction (1,500-1,800 kcal for males; 1,200-1,500 kcal for females). |
|
| From enrollment to the end of treatment at 12 weeks |
| TG | triglycerides | From enrollment to the end of treatment at 12 weeks |
| LDL-C | low-density lipoprotein | From enrollment to the end of treatment at 12 weeks |
| HDL-C | high-density lipoprotein | From enrollment to the end of treatment at 12 weeks |
| D004700 | Endocrine System Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |