Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 Diabetes Mellitus, Diabetic Vascular Complications, Multifactorial Intervention, Digital and Network Management
Brief summary
The prevalence of diabetes mellitus has been increasing in recent decades in China, and vascular complication is the major burden in patients with type 2 diabetes. Previous studies demonstrated that only glycemic control was not effective enough to prevent or improve diabetic vascular complications, but guidelines from the Chinese Diabetes Society and other national guidelines recommend an integrated multifactorial treatment approach. In this study, we aim to evaluate the effect on diabetic vascular complications of a multifactorial intervention comprising behavior modification, polypharmacological therapy and periodical monitoring in patients with type 2 diabetes.
Interventions
BEHAVIORALLifestyle 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.
DRUGPharmacotherapy
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.
OTHERMonitoring 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.
OTHERGeneral treatment
General treatment is carried out based on the device from the general practitioners at present.
Sponsors
The Affiliated Hospital of Qingdao University
The First Hospital of Jilin University
The First People's Hospital of Yinchuan
Beijing Hospital, National Center of Gerontology
The First Affiliated Hospital of Air Force Medicial University
Inner Mongolia People's Hospital
The Affiliated Hospital of Inner Mongolia Medical University
Fujian Medical University Union Hospital
The Fourth Affiliated Hospital of Harbin Medical University
Yantai Yuhuangding Hospital Affiliated to Qingdao University
Shandong Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 35-75 years old; 2. diagnosed as type 2 diabetes according to the criteria of the World Health Organization in 1999.
Exclusion criteria
1. type 1 diabetes，specific types of diabetes，gestational diabetes or pregestational diabetes; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Integrated management rate of multiple risk factor in type 2 diabetes | 30 months | Multiple risk factor: plasma glucose, blood pressure, serum lipid profiles and obesity |
| Incidence of diabetic vascular complications | 30 months | Diabetic vascular complications: both macrovascular and microvascular complications |
| Control rate of diabetes and diabetic vascular complications | 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimated glomerular filtration rate (eGFR) | 30 months |
| Carotid intima-media thickness (IMT) | 30 months |
| Stage of diabetic retinopathy evaluated by fundus photograph | 30 months |
| Ankle brachial index (ABI) | 30 months |
| Urine albumin creatinine ratio (UACR) | 30 months |
Countries
China
Contacts
Primary ContactXu Hou
Outcome results
None listed