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".

Study Overview

• Status: Unknown
• Conditions: Endothelial Dysfunction
• Intervention / Treatment: Drug: Intensive multifactorial group; Drug: conventional multifactorial therapy group

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 Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiang Guangda, MD, Ph D; Phone Number: 862768878410; Email: Guangda64@hotmail.com
• Study Contact Backup: Name: Yue Ling, MD, Ph D; Phone Number: 862768879059; Email: Yueling@med.mail.com.cn

Study Locations

• China
  • Hubei
    • Wuhan City, Hubei, China, 430070
      • Recruiting
      • Department of Endocrinology
      • Contact: Xiang Guangda, MD, Ph D; Phone Number: +862768878410; Email: Guangda64@hotmail.com
      • Principal Investigator: Xiang Guangda, MD, Ph D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive multifactorial group; Intensive multifactorial therapy group receive intensive blood glucose, blood pressure and blood lipids control.	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.; Other Names: Intensive group
Experimental: conventional multifactorial therapy group; Conventional multifactorial therapy group receive conventional blood glucose, blood lipids and blood lipids control to the local targets.	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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xiang Guang-da
• Investigators: Study Director: Xiang Guangda, MD.Ph D, Wuhan General Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 6, 2010
• First Submitted That Met QC Criteria: April 9, 2010
• First Posted (Estimate): April 12, 2010

Study Record Updates

• Last Update Posted (Estimate): July 8, 2013
• Last Update Submitted That Met QC Criteria: July 4, 2013
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; Intensive therapy; Newly diagnosed type 2 diabetes; Metabolic Memorial Effect
• Other Study ID Numbers: q9jhrvf3