Multifactorial Intervention on Diabetes (MIDiab Study)

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

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: 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.

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

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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• The First People's Hospital of Yinchuan

  collaborator OTHER

• Beijing Hospital, National Center of Gerontology

  collaborator UNKNOWN

• The First Affiliated Hospital of Air Force Medicial University

  collaborator OTHER

• Inner Mongolia People's Hospital

  collaborator OTHER

• The Affiliated Hospital of Inner Mongolia Medical University

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• The Fourth Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Yantai Yuhuangding Hospital Affiliated to Qingdao University

  collaborator UNKNOWN

• Shandong Provincial Hospital

  lead OTHER_GOV

Principal Investigators

• Jiajun Zhao, MD,PhD · Shandong Provincial Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-01

Primary Completion

2021-12-31

Completion

2022-12-31

Countries

• China

Study Locations