NCT01101503

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Xiang Guang-da · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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".

Detailed 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.

Conditions

• Endothelial Dysfunction

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2010-04-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2010-04-12
• Last updated: 2013-07-08

Locations

1 site across 1 country: China