Multifactorial Intervention on Diabetes (MIDiab Study)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Lifestyle therapy; Drug: Pharmacotherapy; Other: Monitoring and management; Other: General treatment

• Study Type: Interventional
• Enrollment (Anticipated): 6300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xu Hou; Phone Number: +8615153285655; Email: 15153285655@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250021
      • Not yet recruiting
      • Shandong Provincial Hospital
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Provincial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrated Treatment	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)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	Other: General treatment; General treatment is carried out based on the device from the general practitioners at present.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of diabetic vascular complications	Diabetic vascular complications: both macrovascular and microvascular complications	30 months
Control rate of diabetes and diabetic vascular complications		30 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shandong Provincial Hospital
• Collaborators: The Affiliated Hospital of Qingdao University; The First Hospital of Jilin University; Fujian Medical University Union Hospital; The Affiliated Hospital of Inner Mongolia Medical University; Inner Mongolia People's Hospital; The Fourth Affiliated Hospital of Harbin Medical University; The First People's Hospital of Yinchuan; Beijing Hospital, National Center of Gerontology; The First Affiliated Hospital of Air Force Medicial University; Yantai Yuhuangding Hospital Affiliated to Qingdao University
• Investigators: Study Chair: Jiajun Zhao, MD,PhD, Shandong Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 22, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 5, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; Diabetic Vascular Complications; Multifactorial Intervention; Digital and Network Management
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2017YFC1309800

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No