Multifactorial Intervention on Diabetes (MIDiab Study)

Phase 4

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Lifestyle therapy; Other: General treatment; Drug: Pharmacotherapy; Other: Monitoring and management

• Registration Number: NCT03430284
• Lead Sponsor: Shandong Provincial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-12
• Study Start: 2018-04-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-05
• Last Update Posted: 2021-07-09
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated Treatment	Lifestyle therapy	-
Integrated Treatment	Pharmacotherapy	-
Integrated Treatment	Monitoring and management	-
General Treatment	General treatment	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China