Multifactorial Intervention on Diabetes (MIDiab Study)

NCT ID: NCT03430284

Last Updated: 2021-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

6300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Integrated Treatment

Group Type EXPERIMENTAL

Lifestyle therapy

Intervention Type BEHAVIORAL

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.

Pharmacotherapy

Intervention Type DRUG

Pharmacological therapy is individualized. 1.Glucose-lowering agents:

1. Oral antihyperglycemic agents:Biguanides;Sulfonylureas;Thiazolidinediones;Glinides;a-Glucosidase inhibitors;DPP-4 inhibitors;Sodium-glucose cotransporter 2 inhibitors
2. GLP-1 receptor agonist
3. 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.

Monitoring and management

Intervention Type OTHER

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

Group Type OTHER

General treatment

Intervention Type OTHER

General treatment is carried out based on the device from the general practitioners at present.

Interventions

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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.

Intervention Type BEHAVIORAL

Pharmacotherapy

Pharmacological therapy is individualized. 1.Glucose-lowering agents:

1. Oral antihyperglycemic agents:Biguanides;Sulfonylureas;Thiazolidinediones;Glinides;a-Glucosidase inhibitors;DPP-4 inhibitors;Sodium-glucose cotransporter 2 inhibitors
2. GLP-1 receptor agonist
3. 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.

Intervention Type DRUG

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.

Intervention Type OTHER

General treatment

General treatment is carried out based on the device from the general practitioners at present.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

The First People's Hospital of Yinchuan

OTHER

Sponsor Role collaborator

Beijing Hospital, National Center of Gerontology

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Air Force Medicial University

OTHER

Sponsor Role collaborator

Inner Mongolia People's Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

The Fourth Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Yantai Yuhuangding Hospital Affiliated to Qingdao University

UNKNOWN

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jia-jun Zhao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiajun Zhao, MD,PhD

Role: STUDY_CHAIR

Shandong Provincial Hospital

Locations

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Shandong Provincial Hospital

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xu Hou

Role: CONTACT

+8615153285655

Facility Contacts

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Shanshan Shao

Role: primary

+8653168776094

Other Identifiers

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2017YFC1309800

Identifier Type: -

Identifier Source: org_study_id

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