Multifactorial Intervention on Diabetes (MIDiab Study)

Effects of Multifactorial Intervention on Type 2 Diabetes - A Multicenter, Open-Label, Randomized, Parallel Controlled, Community Trial.

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

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.

Type 2 Diabetes Mellitus, Diabetic Vascular Complications, Multifactorial Intervention, Digital and Network Management

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.

Pharmacological therapy is individualized. 1.Glucose-lowering agents: Oral antihyperglycemic agents:Biguanides;Sulfonylureas;Thiazolidinediones;Glinides;a-Glucosidase inhibitors;DPP-4 inhibitors;Sodium-glucose cotransporter 2 inhibitors GLP-1 receptor agonist 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.

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.

Inclusion Criteria: 35-75 years old; diagnosed as type 2 diabetes according to the criteria of the World Health Organization in 1999. Exclusion Criteria: type 1 diabetes，specific types of diabetes，gestational diabetes or pregestational diabetes; acute cardiovascular or cerebrovascular accidents within past 3 months; severe hepatic or renal dysfunction; malignant tumor; allergic history or contraindication for any drugs in trials; taking part in other clinical trials; obviously poor compliance.