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

Xiang Guang-da

Status and phase: Unknown; Phase 2

Conditions: Endothelial Dysfunction

Treatments: Drug: Intensive multifactorial group; Drug: conventional multifactorial therapy group

Study type: Interventional

Funder types: Other

Identifiers

NCT01101503

q9jhrvf3

Details and patient eligibility

About

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".

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups

Intensive multifactorial group

Experimental group

Description:

Intensive multifactorial therapy group receive intensive blood glucose, blood pressure and blood lipids control.

Treatment:

Drug: Intensive multifactorial group

conventional multifactorial therapy group

Experimental group

Description:

Conventional multifactorial therapy group receive conventional blood glucose, blood lipids and blood lipids control to the local targets.

Treatment:

Drug: conventional multifactorial therapy group