The Cardiopathic Features and Analysis of Risk Factors in the Elderly Diabetic

NCT ID: NCT00940082

Last Updated: 2011-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2015-10-31

Brief Summary

Objectives: To investigate the cardiac condition of the diabetic patients in our hospital in order to seek for the new diagnostic method of warning its cardiovascular complications in early times.

Methods: 317 diabetic patients in our hospital from January in 2004 to July in 2008 were divided into 2 groups: group A (106 patients whose age ranged from (31-59) and group B (211 patients whose age ranged from (60-90). The height, weight, blood glucose, glycosylated hemoglobin, lipid, blood pressure, course of disease, ejection fraction (EF), fractional shortening(FS), diameter of left ventricle in late diastolic stage(LVEDd), the thickness of the ventricular septa（IVSDand the posterior wall of the right ventricle in late diastolic stage (LVPWd)were recorded respectively. Left ventricular mass index (LVMI), relative wall thickness (RWT) were calculated and High-sensitive C-reactive protein (HsCRP), homocysteine and TNF-α were detected. Multifactor logistic regression was made based on the comparison and contrast between all indexes to analyze the correlations between age and the positive indexes.

Detailed Description

Diabetes is one of the commonly seen health hazards in modern times. According to statistics, 70% people with diabetes have died of cardiovascular diseases.

Framingham 's study has proven the increase of the congestive heart-failure (2.4:1 in male patients and5:1 in female patients), which has no association with the age, hypertension, obesity, cardiovascular disease and Hyperlipidemia[1]. Other prospective studies also showed that the patients with diabetes in the early stage may be subject to abnormal echocardiogram and their probabilities of suffering from heart failure in the lifetime and Q-wave and non-Q wave myocardial infarction will be increased[1,2]. Early in 2000, American Heart Association issued a statement that "diabetes is a cardiovascular disease" [3]and in 2007, with reference to the joint guidelines concerning diabetes, pre-diabetes and cardiovascular disease, European Society of Cardiology (ESC) and the European Diabetes Research Institute (ESAD) clearly pointed out that hyperglycemia and cardiovascular disease (CVD) are closely related and the danger of CVD can be raised notably for those whose blood glucose is normal when fasting but tend to increase postprandially[4]. In the pathogenesis study of cardiovascular complications of diabetes, the promotion of oxidative stress and declination of the heart antioxidant reserves have close associations with the cardiovascular complications in animal and human body[5]. A number of cytokines and inflammatory signaling pathways are involved including tumor necrosis factor-α (TNF-α), high-sensitivity C-reactive protein (HsCRP), adiponectin, IL-6, NF-κB[1,6]. Accordingly, this study analyzes the echocardiography, high-sensitivity C-reactive protein and tumor necrosis factor-α of the patients with diabetics in our hospital in order to find early warning indicators of the cardiovascular complications of diabetes and provide prevention and treatment for cardiovascular complications of diabetes.

Conditions

Two-Dimensional Echocardiography

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

youth control group

healthy people which ages from 30 to 59

No interventions assigned to this group

youth diabetes group

type 1 and type 2 diabetes patients which ages from 30 to 59

No interventions assigned to this group

the elderly diabetes group

type 1 and type 2 diabetes patients which ages from 60 to 90

No interventions assigned to this group

elderly control group

healthy people which ages from 60 to 90

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• In-patient or out-patient patients diagnosed with diabetes
• Over 18 years of age
• Gender-open
• The type of diabetes (type 1 or type 2) open
• Patients receive a written informed consent to participate in the trial

Exclusion Criteria

• those diabetic patients with acute and chronic infection, high blood pressure, special and Gestational diabetes Serious complications of heart, liver, lung, kidney damage Malignant tumors
• Pregnant women and breast-feeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Wu Qinan

Ethics Committee of Third Military Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chen Bing, doctor

Role: STUDY_DIRECTOR

Endocrine Department, the south west Hospital of the Third Military Medical University

Locations

Endocrine Department, the First Affiliated Hospital of the Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wu Qinan, master

Role: CONTACT

wqn11@126.com

13452867542

Chen Bing, doctor

Role: CONTACT

wqn1111@yahoo.com.cn

023 68765217

Facility Contacts

qinan wu, master

Role: primary

wqn11@126.com

02368765217 ext. 86

Other Identifiers

Endocrine Department

Identifier Type: -

Identifier Source: secondary_id

the south west Hospital

Identifier Type: -

Identifier Source: org_study_id