Multifactorial Intervention on Diabetes (MIDiab Study)

Sponsor

Shandong Provincial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03430284

Collaborator

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 (Other), First Affiliated Hospital of Air Force Military Medical 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 (Other)

6,300

Enrollment

Locations

Arms

Anticipated Duration (Months)

3150

Patients Per Site

55.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Behavioral: Lifestyle therapy Drug: Pharmacotherapy Other: Monitoring and management Other: General treatment	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Integrated Treatment	Behavioral: 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. Drug: Pharmacotherapy 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. Other: 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.
Other: General Treatment	Other: General treatment General treatment is carried out based on the device from the general practitioners at present.

Arm

Intervention/Treatment

Experimental: Integrated Treatment

Behavioral: 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.

Drug: Pharmacotherapy

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.

Other: 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.

Other: General Treatment

Other: General treatment

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Carotid intima-media thickness (IMT) [30 months]
Ankle brachial index (ABI) [30 months]
Urine albumin creatinine ratio (UACR) [30 months]
Estimated glomerular filtration rate (eGFR) [30 months]
Stage of diabetic retinopathy evaluated by fundus photograph [30 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.