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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

Tracking Information
First Submitted Date  ICMJE January 22, 2018
First Posted Date  ICMJE February 12, 2018
Last Update Posted Date September 5, 2018
Actual Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
  • 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
  • Incidence of diabetic vascular complications [ Time Frame: 30 months ]
    Diabetic vascular complications: both macrovascular and microvascular complications
  • Control rate of diabetes and diabetic vascular complications [ Time Frame: 30 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03430284 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
  • Carotid intima-media thickness (IMT) [ Time Frame: 30 months ]
  • Ankle brachial index (ABI) [ Time Frame: 30 months ]
  • Urine albumin creatinine ratio (UACR) [ Time Frame: 30 months ]
  • Estimated glomerular filtration rate (eGFR) [ Time Frame: 30 months ]
  • Stage of diabetic retinopathy evaluated by fundus photograph [ Time Frame: 30 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multifactorial Intervention on Diabetes (MIDiab Study)
Official Title  ICMJE Effects of Multifactorial Intervention on Type 2 Diabetes - A Multicenter, Open-Label, Randomized, Parallel Controlled, Community Trial.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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.
  • Other: General treatment
    General treatment is carried out based on the device from the general practitioners at present.
Study Arms  ICMJE
  • Experimental: Integrated Treatment
    Interventions:
    • Behavioral: Lifestyle therapy
    • Drug: Pharmacotherapy
    • Other: Monitoring and management
  • General Treatment
    Intervention: Other: General treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2018)
6300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xu Hou +8615153285655 15153285655@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03430284
Other Study ID Numbers  ICMJE 2017YFC1309800
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jia-jun Zhao, Shandong Provincial Hospital
Study Sponsor  ICMJE Shandong Provincial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jiajun Zhao, MD,PhD Shandong Provincial Hospital
PRS Account Shandong Provincial Hospital
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP