Multifactorial Intervention on Diabetes (MIDiab Study)

Shandong First Medical University

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Lifestyle therapy; Other: General treatment; Drug: Pharmacotherapy; Other: Monitoring and management

Study type: Interventional

Funder types: Other

Identifiers

NCT03430284

2017YFC1309800

Details and patient eligibility

About

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.

Enrollment: 6,300 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 35-75 years old;
2. diagnosed as type 2 diabetes according to the criteria of the World Health Organization in 1999.

Exclusion criteria

1. type 1 diabetes，specific types of diabetes，gestational diabetes or pregestational diabetes;
2. acute cardiovascular or cerebrovascular accidents within past 3 months;
3. severe hepatic or renal dysfunction;
4. malignant tumor;
5. allergic history or contraindication for any drugs in trials;
6. taking part in other clinical trials;
7. obviously poor compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,300 participants in 2 patient groups

Integrated Treatment

Experimental group

Treatment:

Drug: Pharmacotherapy

Behavioral: Lifestyle therapy

Other: Monitoring and management

General Treatment

Other group

Treatment:

Other: General treatment