Clinical trial NCT03430284: Multifactorial Intervention on Diabetes (MIDiab Study)
Official title: Effects of Multifactorial Intervention on Type 2 Diabetes - A Multicenter, Open-Label, Randomized, Parallel Controlled, Community Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes Mellitus
Diabetic Vascular Complications
Multifactorial Intervention
Digital and Network Management
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
Collaborators: name: The Affiliated Hospital of Qingdao University
name: The First Hospital of Jilin University
name: The First People's Hospital of Yinchuan
name: Beijing Hospital, National Center of Gerontology
name: The First Affiliated Hospital of Air Force Medicial University
name: Inner Mongolia People's Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
name: Fujian Medical University Union Hospital
name: The Fourth Affiliated Hospital of Harbin Medical University
name: Yantai Yuhuangding Hospital Affiliated to Qingdao University
First posted: 2018-02-12
Enrollment: 6300
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Integrated management rate of multiple risk factor in type 2 diabetes
timeFrame: 30 months
measure: Incidence of diabetic vascular complications
timeFrame: 30 months
measure: Control rate of diabetes and diabetic vascular complications
timeFrame: 30 months
Secondary outcomes:
measure: Carotid intima-media thickness (IMT)
timeFrame: 30 months
measure: Ankle brachial index (ABI)
timeFrame: 30 months
measure: Urine albumin creatinine ratio (UACR)
timeFrame: 30 months
measure: Estimated glomerular filtration rate (eGFR)
timeFrame: 30 months
measure: Stage of diabetic retinopathy evaluated by fundus photograph
timeFrame: 30 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Jiajun Zhao, MD,PhD
role: STUDY_CHAIR
References: