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

NCT01101503 | Unknown Phase 2 DMC

• 1 other identifier: q9jhrvf3
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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".

Conditions

Endothelial Dysfunction

Keywords

Newly diagnosed type 2 diabetes; Endothelial dysfunction; Intensive therapy; Metabolic Memorial Effect

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intensive multifactorial group

EXPERIMENTAL

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

Drug: Intensive multifactorial group

conventional multifactorial therapy group

EXPERIMENTAL

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

Drug: conventional multifactorial therapy group

Interventions

Intensive multifactorial group 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.

Also known as: Intensive group

Intensive multifactorial group

conventional multifactorial therapy group 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.

conventional multifactorial therapy group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed type 2 diabetes,
• Age: 40 \>= age \<=70 year old,

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiang Guang-da: lead

Study Sites (1)

Department of Endocrinology

Wuhan, Hubei, 430070, China

RECRUITING

Study Officials

• Xiang Guangda, MD.Ph D

  Wuhan General Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiang Guangda, MD, Ph D

CONTACT

862768878410; Guangda64@hotmail.com

Yue Ling, MD, Ph D

CONTACT

862768879059; Yueling@med.mail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Endocrinol Dept.

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 12, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 8, 2013

Record last verified: 2010-03

Locations

CN (1)