Multifactorial Intervention on Diabetes (MIDiab Study) | NCT03430284

Name	Class
The Affiliated Hospital of Qingdao University	OTHER
The First Hospital of Jilin University	OTHER
The First People's Hospital of Yinchuan	OTHER

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.

Label	Type	Description	Intervention Names
Integrated Treatment	Experimental		Behavioral: Lifestyle therapy Drug: Pharmacotherapy Other: Monitoring and management
General Treatment	Other		Other: General treatment

Name	Type	Description	Arm Group Labels	Other Names
Lifestyle therapy	Behavioral	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.

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.

Measure	Description	Time Frame
Integrated management rate of multiple risk factor in type 2 diabetes	Multiple risk factor: plasma glucose, blood pressure, serum lipid profiles and obesity	30 months
Incidence of diabetic vascular complications	Diabetic vascular complications: both macrovascular and microvascular complications	30 months
Control rate of diabetes and diabetic vascular complications		30 months

Multiple risk factor: plasma glucose, blood pressure, serum lipid profiles and obesity

Diabetic vascular complications: both macrovascular and microvascular complications

Measure	Description	Time Frame
Carotid intima-media thickness (IMT)		30 months
Ankle brachial index (ABI)		30 months
Urine albumin creatinine ratio (UACR)

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.

Name	Role	Phone	Extension	Email
Xu Hou	Contact	+8615153285655		15153285655@163.com

Name	Affiliation	Role
Jiajun Zhao, MD,PhD	Shandong Provincial Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Shandong Provincial Hospital	Not yet recruiting	Jinan	Shandong	250021	China

ID	Term
D003924	Diabetes Mellitus, Type 2
D003925	Diabetic Angiopathies

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D004358	Drug Therapy
D013812	Therapeutics

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.

General treatment is carried out based on the device from the general practitioners at present.