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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by Third Military Medical University
Sponsor:
Information provided by (Responsible Party):
Wu Qinan, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT00940082
First received: July 14, 2009
Last updated: September 11, 2011
Last verified: September 2011
  Purpose

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.


Condition
Two-Dimensional Echocardiography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Cardiopathic Features and Analysis of Risk Factors in the Elderly Diabetic

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • the gender, height, weight, blood pressure, course of the disease of each patient was recorded [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Left ventricular mass index (LVMI), relative wall thickness (RWT) were calculated and High-sensitive C-reactive protein (HsCRP), homocysteine and TNF-α were detected [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Take the fasting blood more than 12 hours overnight


Estimated Enrollment: 400
Study Start Date: June 2007
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
youth control group
healthy people which ages from 30 to 59
youth diabetes group
type 1 and type 2 diabetes patients which ages from 30 to 59
the elderly diabetes group
type 1 and type 2 diabetes patients which ages from 60 to 90
elderly control group
healthy people which ages from 60 to 90

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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  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: NCT00940082

Contacts
Contact: Wu Qinan, master 13452867542 wqn11@126.com
Contact: Chen Bing, doctor 023 68765217 wqn1111@yahoo.com.cn

Locations
China, Chongqing
Endocrine Department, the First Affiliated Hospital of the Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400038
Contact: qinan wu, master    02368765217 ext 86    wqn11@126.com   
Sub-Investigator: qinan wu, master         
Sponsors and Collaborators
Third Military Medical University
Investigators
Study Director: Chen Bing, doctor Endocrine Department, the south west Hospital of the Third Military Medical University
  More Information

No publications provided

Responsible Party: Wu Qinan, Ethics Committee of Third Military Medical University, Third Military Medical University
ClinicalTrials.gov Identifier: NCT00940082     History of Changes
Other Study ID Numbers: the south west Hospital, Endocrine Department
Study First Received: July 14, 2009
Last Updated: September 11, 2011
Health Authority: China: National Natural Science Foundation

Keywords provided by Third Military Medical University:
Diabetes;
Echocardiography;
High-sensitive C-reactive protein;
homocysteine;
TNF-α

ClinicalTrials.gov processed this record on September 16, 2014