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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Shanghai Punan Hospital of Pudong New District | OTHER |
| Shanghai 6th People's Hospital | OTHER |
| Jinzhou Medical University |
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Semaglutide has effects that include lowering blood sugar, reducing weight, and improving cardiovascular and renal outcomes, and it is now widely used in clinical practice. Given that weight loss is associated with bone loss, its effect on bone health has recently raised concerns. Therefore, the goal of this clinical trial is to learn the effect of semaglutide on bone mineral density and fractures in patients with type 2 diabetes.
The investigators will compare semaglutide combined with metformin to metformin alone to see if semaglutide treatment has effects on bone mineral density and bone turnover markers in patients with type 2 diabetes after 12 months.
The intervention group will receive semaglutide combined with metformin for 12 months, while the control group will receive metformin alone for the same duration. After 12 months of treatment, the investigators will compare the bone mineral density, fracture incidence, and levels of bone turnover markers between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The intervention group | Experimental | In the intervention group, the participants will receive semaglutide combined with metformin treatment. |
|
| The control group | No Intervention | In the control group, the participants will be treated with metformin alone (500mg each time, three times a day). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide combined with metformin | Drug | The initial dose of semaglutide is 0.25 mg once weekly. After 4 weeks, the dose is adjusted to 0.5 mg once weekly. After another 4 weeks, the dose is adjusted to 1 mg once weekly. During the same period, they will take metformin (500mg each time, three times a day) for treatment. The treatment course is 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| lumbar bone mineral density | From enrollment to the end of treatment at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiulin Shi | Contact | 0592-2139940 | shixiulin2022@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D058866 | Osteoporotic Fractures |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| OTHER |
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|
| D009750 |
| Nutritional and Metabolic Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |