Endothelial Dysfunction
Conditions
Keywords
Newly diagnosed type 2 diabetes, Endothelial dysfunction, Intensive therapy, Metabolic Memorial Effect
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.
Interventions
DRUGIntensive 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.
DRUGconventional 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
Xiang Guang-da
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactXiang Guangda, MD, Ph D
Backup ContactYue Ling, MD, Ph D
Outcome results
None listed