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Multifactorial Intervention on Diabetes (MIDiab Study)

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ClinicalTrials.gov Identifier: NCT03430284
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jia-jun Zhao, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Lifestyle therapy Drug: Pharmacotherapy Other: Monitoring and management Other: General treatment Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Multifactorial Intervention on Type 2 Diabetes - A Multicenter, Open-Label, Randomized, Parallel Controlled, Community Trial.
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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:

  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.


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




Primary Outcome Measures :
  1. Integrated management rate of multiple risk factor in type 2 diabetes [ Time Frame: 30 months ]
    Multiple risk factor: plasma glucose, blood pressure, serum lipid profiles and obesity

  2. Incidence of diabetic vascular complications [ Time Frame: 30 months ]
    Diabetic vascular complications: both macrovascular and microvascular complications

  3. Control rate of diabetes and diabetic vascular complications [ Time Frame: 30 months ]

Secondary Outcome Measures :
  1. Carotid intima-media thickness (IMT) [ Time Frame: 30 months ]
  2. Ankle brachial index (ABI) [ Time Frame: 30 months ]
  3. Urine albumin creatinine ratio (UACR) [ Time Frame: 30 months ]
  4. Estimated glomerular filtration rate (eGFR) [ Time Frame: 30 months ]
  5. Stage of diabetic retinopathy evaluated by fundus photograph [ Time Frame: 30 months ]


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430284


Contacts
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Contact: Xu Hou +8615153285655 15153285655@163.com

Locations
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China, Shandong
Shandong Provincial Hospital Not yet recruiting
Jinan, Shandong, China, 250021
Contact: Shanshan Shao    +8653168776094    shaoshanshan11@126.com   
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
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Study Chair: Jiajun Zhao, MD,PhD Shandong Provincial Hospital

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Responsible Party: Jia-jun Zhao, Professor, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT03430284     History of Changes
Other Study ID Numbers: 2017YFC1309800
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jia-jun Zhao, Shandong Provincial Hospital:
Type 2 Diabetes Mellitus
Diabetic Vascular Complications
Multifactorial Intervention
Digital and Network Management
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases