Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
6300 participants
INTERVENTIONAL
2018-04-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Integrated Treatment
Lifestyle therapy
The key components of lifestyle therapy include medical nutrition therapy, regular physical activity, sufficient amounts of sleep, behavioral support, and smoking cessation and avoidance of all tobacco products.
Pharmacotherapy
Pharmacological therapy is individualized. 1.Glucose-lowering agents:
1. Oral antihyperglycemic agents:Biguanides;Sulfonylureas;Thiazolidinediones;Glinides;a-Glucosidase inhibitors;DPP-4 inhibitors;Sodium-glucose cotransporter 2 inhibitors
2. GLP-1 receptor agonist
3. Insulin:Rapid-acting analogs;Short-acting analogs;Intermediate-acting analogs;Basal insulin analogs;Premixed insulin products
2.Blood pressure-lowering agents
(1)ACE inhibitor;(2)Angiotensin receptor blockers (ARBs);(3)Calcium channel blockers (CCB);(4)Diuretics;(5)β-blockers;(6)α1-blockers
3.Lipid-modifying agents
(1)Statins;(2)Fibrates;(3)Others: Nicotinic Acid, Ezetimibe,Probucol,Bile Acid Sequestrants,Policosanol,etc.
4.Medications for weight management
(1)Glucose-lowering agents associated with weight loss;(2)Orlistat;(3)Metabolic Surgery
The above medications are individualized to maintain the risk factors (blood glucose, serum lipid profiles, blood pressure and weight) at appropriate levels.
Monitoring and management
Before follow-up, patients are divided into low, moderate or high risk for diabetic vascular complications. During follow-up, frequencies of interview and risk factor monitoring are formulated based on the risk stratification.
General Treatment
General treatment
General treatment is carried out based on the device from the general practitioners at present.
Interventions
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Lifestyle therapy
The key components of lifestyle therapy include medical nutrition therapy, regular physical activity, sufficient amounts of sleep, behavioral support, and smoking cessation and avoidance of all tobacco products.
Pharmacotherapy
Pharmacological therapy is individualized. 1.Glucose-lowering agents:
1. Oral antihyperglycemic agents:Biguanides;Sulfonylureas;Thiazolidinediones;Glinides;a-Glucosidase inhibitors;DPP-4 inhibitors;Sodium-glucose cotransporter 2 inhibitors
2. GLP-1 receptor agonist
3. Insulin:Rapid-acting analogs;Short-acting analogs;Intermediate-acting analogs;Basal insulin analogs;Premixed insulin products
2.Blood pressure-lowering agents
(1)ACE inhibitor;(2)Angiotensin receptor blockers (ARBs);(3)Calcium channel blockers (CCB);(4)Diuretics;(5)β-blockers;(6)α1-blockers
3.Lipid-modifying agents
(1)Statins;(2)Fibrates;(3)Others: Nicotinic Acid, Ezetimibe,Probucol,Bile Acid Sequestrants,Policosanol,etc.
4.Medications for weight management
(1)Glucose-lowering agents associated with weight loss;(2)Orlistat;(3)Metabolic Surgery
The above medications are individualized to maintain the risk factors (blood glucose, serum lipid profiles, blood pressure and weight) at appropriate levels.
Monitoring and management
Before follow-up, patients are divided into low, moderate or high risk for diabetic vascular complications. During follow-up, frequencies of interview and risk factor monitoring are formulated based on the risk stratification.
General treatment
General treatment is carried out based on the device from the general practitioners at present.
Eligibility Criteria
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Inclusion Criteria
2. diagnosed as type 2 diabetes according to the criteria of the World Health Organization in 1999.
Exclusion Criteria
2. acute cardiovascular or cerebrovascular accidents within past 3 months;
3. severe hepatic or renal dysfunction;
4. malignant tumor;
5. allergic history or contraindication for any drugs in trials;
6. taking part in other clinical trials;
7. obviously poor compliance.
35 Years
75 Years
ALL
No
Sponsors
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The Affiliated Hospital of Qingdao University
OTHER
The First Hospital of Jilin University
OTHER
The First People's Hospital of Yinchuan
OTHER
Beijing Hospital, National Center of Gerontology
UNKNOWN
The First Affiliated Hospital of Air Force Medicial University
OTHER
Inner Mongolia People's Hospital
OTHER
The Affiliated Hospital of Inner Mongolia Medical University
OTHER
Fujian Medical University Union Hospital
OTHER
The Fourth Affiliated Hospital of Harbin Medical University
OTHER
Yantai Yuhuangding Hospital Affiliated to Qingdao University
UNKNOWN
Shandong Provincial Hospital
OTHER_GOV
Responsible Party
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Jia-jun Zhao
Professor
Principal Investigators
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Jiajun Zhao, MD,PhD
Role: STUDY_CHAIR
Shandong Provincial Hospital
Locations
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Shandong Provincial Hospital
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017YFC1309800
Identifier Type: -
Identifier Source: org_study_id
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