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

Endothelial Dysfunction Clinical Trial

Official title:

The Metabolic Memorial Effect of Early Intensive Multifactorial Treatment in Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01101503
• Other study ID #: q9jhrvf3
• Status: Recruiting
• Phase: Phase 2
• First received: April 6, 2010
• Last updated: July 4, 2013
• Start date: April 2010
• Est. completion date: December 2020

Study information

• Verified date: March 2010
• Source: Wuhan General Hospital of Guangzhou Military Command
• Contact: Xiang Guangda, MD, Ph D
• Phone: 862768878410
• Email: Guangda64[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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".

Description:

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

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: 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. For blood lipids control, target LDL-C < =1.9 mmol/L, triglyceride < =1.5 mmol/L. The drugs include statin and fibrate. 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. Others, such as aspirin.
• 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: 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. 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. 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. Others, such as aspirin.

Locations

Country	Name	City	State
China	Department of Endocrinology	Wuhan City	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xiang Guang-da

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The metabolic memory effect of endothelium-dependent arterial dilation	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.	10 years	Yes