Clinical trial NCT00940082: The Cardiopathic Features and Analysis of Risk Factors in the Elderly Diabetic
Official title: The Cardiopathic Features and Analysis of Risk Factors in the Elderly Diabetic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Two-Dimensional Echocardiography
Keywords: Diabetes;
Echocardiography;
High-sensitive C-reactive protein;
homocysteine;
TNF-α
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2009-07-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 1 and type 2 diabetic patients. They have been included in the standard diagnostic criteria for WHO1999 years and those diabetic patients with acute and chronic infection, high blood pressure, special and Gestational diabetic patients have been excluded. (Judgment have been made according to the case history, physical examination, medication, hormone history, blood routine etc) Those repeatedly hospitalized patients were recorded according to the time they took their first related inspection

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.

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

Primary outcomes:
measure: the gender, height, weight, blood pressure, course of the disease of each patient was recorded
timeFrame: 1 day
Secondary outcomes:
measure: Left ventricular mass index (LVMI), relative wall thickness (RWT) were calculated and High-sensitive C-reactive protein (HsCRP), homocysteine and TNF-α were detected
timeFrame: 1 day
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Endocrine Department, the First Affiliated Hospital of the Third Military Medical University
state: Chongqing
Study officials:
affiliation: Endocrine Department, the south west Hospital of the Third Military Medical University
name: Chen Bing, doctor
role: STUDY_DIRECTOR
References: