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

Phase 2

• Conditions: Endothelial Dysfunction
• Interventions: Drug: Intensive multifactorial group; Drug: conventional multifactorial therapy group

• Registration Number: NCT01101503
• Lead Sponsor: Xiang Guang-da

Brief 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.

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-04
• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-09
• Study First Posted: 2010-04-12
• Last Update Submitted: 2013-07-04
• Last Update Posted: 2013-07-08
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive multifactorial group	Intensive multifactorial group	Intensive multifactorial therapy group receive intensive blood glucose, blood pressure and blood lipids control.
conventional multifactorial therapy group	conventional multifactorial therapy group	Conventional multifactorial therapy group receive conventional blood glucose, blood lipids and blood lipids control to the local targets.

Primary Outcome Measures

Name	Time	Method
The metabolic memory effect of endothelium-dependent arterial dilation	10 years	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.

Trial Locations

Locations (1)

Department of Endocrinology; 🇨🇳 Wuhan City, Hubei, China