The Effect of Intensive Multifactorial Therapy on Endothelial Function in Newly Diagnosed Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2010 by Wuhan General Hospital of Guangzhou Military Command
Sponsor:
Information provided by (Responsible Party):
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT01101503
First received: April 6, 2010
Last updated: July 4, 2013
Last verified: March 2010

April 6, 2010
July 4, 2013
April 2010
December 2020   (final data collection date for primary outcome measure)
The metabolic memory effect of endothelium-dependent arterial dilation [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Before and after intensive multifactorial therapy (one year intensive therapy, HbAic, fasting blood glucose and postprandial 2 hour glucose reach to the targets),endothelial function is measured. The intensive and conventional groups are taken together, and give the same therapy during the follow up of 10 years. The endothelium-dependent arterial dilation is measured during follow up. The aim is that the improvement of endothelial function induced by intensive therapy will exist after 10 years.
endothelium-dependent arterial dilation [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01101503 on ClinicalTrials.gov Archive Site
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The Effect of Intensive Multifactorial Therapy on Endothelial Function in Newly Diagnosed Type 2 Diabetes
The Metabolic Memorial Effect of Early Intensive Multifactorial Treatment in Diabetes

The endothelial dysfunction is the early event in atherosclerosis. The investigator previous study showed that impaired endothelial function exist in newly diagnosed type 2 diabetes. The investigators hypothesize that intensive multifactorial therapy including intensive blood control and intensive hypertension control as well as intensive blood lipids control of 1 year can improve vascular endothelial function. Moreover, the improvement of endothelial function maintains after 5 years or 10 years of intensive multifactorial therapy, called "Metabolic Memorial Effect of improvement of endothelial function".

  • We select 1000 patients with newly diagnosed type 2 diabetes. They are divided into two groups, respectively (Intensive multifactorial therapy and conventional multifactorial therapy groups). After those therapy for one year, a 10 years of follow up study will be performed. During this period, we take them together intensive education, and take conventional multifactorial therapy for both of two groups.
  • At the beginning (0 year),the end of intensive multifactorial therapy (1 year), 5 years and 10 years, we will measure the endothelium-dependent arterial dilation, endothelium related cytokines such as ET-1, vWF,as well as blood glucose, HbA1c for all of individuals.
  • We will compare the endothelial function,endothelium related cytokines such as ET-1, vWF,as well as blood glucose, HbA1c between intensive therapy group and conventional therapy group at different time points.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Endothelial Dysfunction
  • Drug: Intensive multifactorial group

    Intensive multifactorial therapy and conventional multifactorial therapy will be taken for 1 year, and then take them together, and give same treatment for 10 years.

    The intensive multifactorial therapy group:

    1. For blood glucose control, target HbA1c >=5.5%and <=6.0%,fasting blood glucose >=5.0 mmol/L and <=6.0 mmol/L, postprandial 2 hour glucose >= 6.0 mmol/L and <= 7.8 mmol/L. The drugs include insulin, oral hypoglycemic agents.
    2. For blood lipids control, target LDL-C < =1.9 mmol/L, triglyceride < =1.5 mmol/L. The drugs include statin and fibrate.
    3. For blood pressure control, target >=120/70 mmHg and <= 130/80 mmHg. The drugs include ACE inhibitor, angiotensin II-receptor antagonist, diuretic, beta-blocker and calcium-channel blocker.
    4. Others, such as aspirin.
    Other Name: Intensive group
  • Drug: conventional multifactorial therapy group

    Intensive multifactorial therapy and conventional multifactorial therapy will be taken for 1 year, and then take them together, and give same treatment for 10 years.

    The conventional multifactorial therapy group:

    1. For blood glucose control, target HbA1c >6.5%and <=7.0%,fasting blood glucose >6.0 mmol/L and <=7.0 mmol/L, postprandial 2 hour glucose > 7.8 mmol/L and <= 10.0 mmol/L. The drugs include insulin, oral hypoglycemic agents.
    2. For blood lipids control, target LDL-C > 1.9 mmol/L and < =2.5 mmol/L, triglyceride > 1.5 mmol/L and < = 2.5 mmol/L. The drugs include statin and fibrate.
    3. For blood pressure control, target >130/80 mmHg and <= 140/90 mmHg. The drugs include ACE inhibitor, angiotensin II-receptor antagonist, diuretic, beta-blocker and calcium-channel blocker.
    4. Others, such as aspirin.
  • Experimental: Intensive multifactorial group
    Intensive multifactorial therapy group receive intensive blood glucose, blood pressure and blood lipids control.
    Intervention: Drug: Intensive multifactorial group
  • Experimental: conventional multifactorial therapy group
    Conventional multifactorial therapy group receive conventional blood glucose, blood lipids and blood lipids control to the local targets.
    Intervention: Drug: conventional multifactorial therapy group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2020
December 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Newly diagnosed type 2 diabetes,
  • Age: 40 >= age <=70 year old,

Exclusion Criteria:

  • Type 1 diabetes,
  • Mitochondrial diabetes
  • Patients with clinical detectable angiopathy,
  • Body Mass Index (BMI) > 30 Kg/m2,
  • Age < 40, or > 70 years old,
  • Malignant neoplasms, renal or liver diseases,
  • Smokers
  • Known diabetes
Both
40 Years to 70 Years
No
Contact: Xiang Guangda, MD, Ph D 862768878410 Guangda64@hotmail.com
Contact: Yue Ling, MD, Ph D 862768879059 Yueling@med.mail.com.cn
China
 
NCT01101503
q9jhrvf3
Yes
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
Xiang Guang-da
Not Provided
Study Director: Xiang Guangda, MD.Ph D Wuhan General Hospital
Wuhan General Hospital of Guangzhou Military Command
March 2010

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