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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-1-4064 | Other Grant/Funding Number | Capital's Fundsfor Health lmprovement and Research |
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This study used the diabetes prevention and follow-up research queue in Daqing and the public database of UKbiobank to evaluate the risk factors of cardiovascular and cerebrovascular events in diabetes patients, and built the first risk prediction model of cardiovascular and cerebrovascular events in diabetes patients based on the Chinese population follow-up queue and externally verified, so as to identify high-risk groups and guide the early prevention of cardiovascular and cerebrovascular diseases in diabetes patients. To evaluate the effect of incretin drugs on reducing the risk of cardiovascular and cerebrovascular events, and the impact on the remission rate of diabetes in people with initial diabetes, a randomized, multicenter, controlled clinical study was conducted. The long-term follow-up of 2 years was conducted to evaluate whether the cardiovascular and cerebrovascular risks of those who stopped drug treatment after remission of diabetes compared with those who continued drug treatment were reduced, as well as the long-term impact of incretin on cardiovascular and cerebrovascular risks and the role of long-term mitigation of diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin control group | Placebo Comparator | The metformin control group received metformin (gradually increased to 1 g bid) for 24 weeks (6 months) |
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| semaglutide group | Experimental | The Semaglutide intervention group received semaglutide (starting at 0.25mg qw and increasing to 0.5mg qw after four weeks) for 24 weeks (6 months). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | The semaglutide intervention group received semaglutide (0.25 mg qw initially, increased to 0.5 mg qw after four weeks) for 24 weeks (6 months). |
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| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular and cerebrovascular event risk score | The cardiovascular and cerebrovascular event score (0-100%)is based on the cardiovascular and cerebrovascular event risk prediction model for diabetic patients established in Objective 1. In this prediction model, age, gender, smoking status, body mass index, waist circumference, glycated hemoglobin, blood sugar, blood pressure, and blood lipids correspond to certain scores. Higher scores indicate a higher risk of cardiovascular and cerebrovascular events and a worse outcome. | One-year follow-up |
| Major Adverse Cardiovascular Events | The Mace event includes cardiovascular death, non-fatal myocardial infarction and non-fatal stroke. | Baseline and every 12 weeks until 96 weeks |
| Cerebrovascular disease events | Cerebrovascular diseases include ischemic stroke, hemorrhagic stroke, transient ischemic attack, cerebral vascular malformation, etc. | Baseline and every 12 weeks until 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The remission rate of diabetes | at 9 months, 1 year and 2 years of follow-up | |
| Glycated hemoglobin | Reduced levels of glycated hemoglobin | Baseline and every 12 weeks until 96 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship hospital | Beijing | 100029 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin | Drug | The metformin control group was treated with metformin (gradually increasing to 1g bid) for 24 weeks (6 months) |
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| Fasting and postprandial blood glucose levels | at 2 year and 8 year of follow-up |
| pancreatic islet function | The study evaluated pancreatic islet cell function by testing fasting insulin, insulin one hour after a steamed bread meal, and insulin two hours after a steamed bread meal. | Baseline, 48 weeks and 96 weeks |
| Heart rate | The heart rate of the subjects were measured by electrocardiogram when they were at rest. | Baseline, 48 weeks and 96 weeks |
| Carotid artery peak systolic velocity | Evaluate the systolic peak blood flow velocity through carotid artery ultrasound. | Baseline, 48 weeks and 96 weeks |
| Routine urine examination | Evaluate the levels of red blood cells, white blood cells, urine glucose, urine ketones, and urine protein in urine through urine routine testing. | Baseline, 48 weeks and 96 weeks |
| Urine microalbumin | Urine microalbuminuria for early assessment of renal damage. | Baseline, 48 weeks and 96 weeks |
| Heart rhythm | The heart rhythm of the subjects were measured by electrocardiogram when they were at rest. | Baseline, 48 weeks and 96 weeks |
| Carotid artery peak diastolic velocity | Evaluate the diastolic peak blood flow velocity through carotid artery ultrasound. | Baseline, 48 weeks and 96 weeks |
| Carotid resistance index | Evaluate resistance index through carotid artery ultrasound. Carotid resistance index = (peak systolic velocity - end diastolic velocity) / peak systolic velocity | Baseline, 48 weeks and 96 weeks |
| common carotid artery diameter | Evaluate the common carotid artery diameter through carotid artery ultrasound. | Baseline, 48 weeks and 96 weeks |
| Carotid artery wall thickness | Evaluate the wall thickness through carotid artery ultrasound. | Baseline, 48 weeks and 96 weeks |
| Carotid Intima-media Thickness | Evaluate the intimal thickness through carotid artery ultrasound. | Baseline, 48 weeks and 96 weeks |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |