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

NCT ID: NCT01101503

Last Updated: 2013-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2020-12-31

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.

Conditions

Endothelial Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intensive multifactorial group

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

Group Type: EXPERIMENTAL

Intensive multifactorial group

Intervention Type: DRUG

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.

conventional multifactorial therapy group

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

Group Type: EXPERIMENTAL

conventional multifactorial therapy group

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Intensive group

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiang Guang-da

OTHER

Sponsor Role: lead

Responsible Party

Xiang Guang-da

Director of Endocrinol Dept.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiang Guangda, MD.Ph D

Role: STUDY_DIRECTOR

Wuhan General Hospital

Locations

Department of Endocrinology

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiang Guangda, MD, Ph D

Role: CONTACT

Guangda64@hotmail.com

862768878410

Yue Ling, MD, Ph D

Role: CONTACT

Yueling@med.mail.com.cn

862768879059

Facility Contacts

Xiang Guangda, MD, Ph D

Role: primary

Guangda64@hotmail.com

+862768878410

Other Identifiers

q9jhrvf3

Identifier Type: -

Identifier Source: org_study_id