Multifactorial Intervention on Diabetes (MIDiab Study)

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Lifestyle therapy
* Drug: Pharmacotherapy
* Other: Monitoring and management
* Other: General treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Treatment<br> | Behavioral: Lifestyle therapy<br>* 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.<br>Drug: Pharmacotherapy<br>* 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.<br>Other: Monitoring and management<br>* 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.<br>|
| Other: General Treatment<br> | Other: General treatment<br>* General treatment is carried out based on the device from the general practitioners at present.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Diabetic Vascular Complications, Multifactorial Intervention, Digital and Network Management