Multifactorial Intervention on Diabetes (MIDiab Study)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03430284
• Other study ID #: 2017YFC1309800
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Shandong Provincial Hospital
• Contact: Xu Hou
• Phone: +8615153285655
• Email: 15153285655[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6300
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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: 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)ß-blockers;(6)a1-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.
• General treatment
General treatment is carried out based on the device from the general practitioners at present.

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (11)

Lead Sponsor

Collaborator

Shandong Provincial Hospital

Beijing Hospital, National Center of Gerontology, First Affiliated Hospital of Air Force Military Medical University, Fujian Medical University Union Hospital, Inner Mongolia People's Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The Affiliated Hospital of Qingdao University, The First Hospital of Jilin University, The First People's Hospital of Yinchuan, The Fourth Affiliated Hospital of Harbin Medical University, Yantai Yuhuangding Hospital Affiliated to Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of diabetic vascular complications	Diabetic vascular complications: both macrovascular and microvascular complications	30 months
Primary	Control rate of diabetes and diabetic vascular complications		30 months
Secondary	Carotid intima-media thickness (IMT)		30 months
Secondary	Ankle brachial index (ABI)		30 months
Secondary	Urine albumin creatinine ratio (UACR)		30 months
Secondary	Estimated glomerular filtration rate (eGFR)		30 months
Secondary	Stage of diabetic retinopathy evaluated by fundus photograph		30 months