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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2010 by Wuhan General Hospital of Guangzhou Military Command
Sponsor:
Information provided by (Responsible Party):
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT01101503
First received: April 6, 2010
Last updated: July 4, 2013
Last verified: March 2010
  Purpose

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".


Condition Intervention Phase
Endothelial Dysfunction
Drug: Intensive multifactorial group
Drug: conventional multifactorial therapy group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Metabolic Memorial Effect of Early Intensive Multifactorial Treatment in Diabetes

Resource links provided by NLM:


Further study details as provided by Wuhan General Hospital of Guangzhou Military Command:

Primary Outcome Measures:
  • The metabolic memory effect of endothelium-dependent arterial dilation [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 1000
Study Start Date: April 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  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.
Other Name: 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:

  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.

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.
  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101503

Contacts
Contact: Xiang Guangda, MD, Ph D 862768878410 Guangda64@hotmail.com
Contact: Yue Ling, MD, Ph D 862768879059 Yueling@med.mail.com.cn

Locations
China, Hubei
Department of Endocrinology Recruiting
Wuhan City, Hubei, China, 430070
Contact: Xiang Guangda, MD, Ph D    +862768878410    Guangda64@hotmail.com   
Principal Investigator: Xiang Guangda, MD, Ph D         
Sponsors and Collaborators
Xiang Guang-da
Investigators
Study Director: Xiang Guangda, MD.Ph D Wuhan General Hospital
  More Information

No publications provided

Responsible Party: Xiang Guang-da, Director of Endocrinol Dept., Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT01101503     History of Changes
Other Study ID Numbers: q9jhrvf3
Study First Received: April 6, 2010
Last Updated: July 4, 2013
Health Authority: China: Ethics Committee

Keywords provided by Wuhan General Hospital of Guangzhou Military Command:
Newly diagnosed type 2 diabetes
Endothelial dysfunction
Intensive therapy
Metabolic Memorial Effect

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Calcium Channel Blockers
Angiotensin Receptor Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014