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

NCT01101503 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2013-07-08

No results posted yet for this study

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".

Conditions

  • Endothelial Dysfunction

Interventions

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.

Sponsors & Collaborators

  • Xiang Guang-da

    lead OTHER

Principal Investigators

  • Xiang Guangda, MD.Ph D · Wuhan General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01101503 on ClinicalTrials.gov