Two-Dimensional EchocardiographyNCT00940082
The Cardiopathic Features and Analysis of Risk Factors in the Elderly Diabetic
An observational study of Two-Dimensional Echocardiography, run by Third Military Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Two-Dimensional Echocardiography
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Jun 2007to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Endocrine Department, the First Affiliated Hospital of the Third Military Medical University
Chongqing, Chongqing Municipality, 400038
qinan wu, master, 02368765217 ext. 86, wqn11@126.com
qinan wu, master
About this study
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.
Read the 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
- Keywords
- Diabetes;, Echocardiography;, High-sensitive C-reactive protein;, homocysteine;, TNF-α
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the gender, height, weight, blood pressure, course of the disease of each patient was recorded
Measured: 1 day
Secondary outcomes (1)
Left ventricular mass index (LVMI), relative wall thickness (RWT) were calculated and High-sensitive C-reactive protein (HsCRP), homocysteine and TNF-α were detected
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startJun 2007
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Two-Dimensional EchocardiographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Qinan, Third Military Medical University
- Investigators
- Chen Bing, doctor, Study director, Endocrine Department, the south west Hospital of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940082
- Sponsor's protocol ID
- the south west Hospital
- Other IDs
- Endocrine Department
- Status last verified
- Sep 2011
- First submitted
- 14 Jul 2009
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiopathic Features and Analysis of Risk Factors in the Elderly Diabetic
- ClinicalTrials.gov ID
- NCT00940082
- Acronym / sponsor ID
- the south west Hospital
- Conditions
- Two-Dimensional Echocardiography
- Keywords
- Diabetes;, Echocardiography;, High-sensitive C-reactive protein;, homocysteine;, TNF-α
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 15 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the gender, height, weight, blood pressure, course of the disease of each patient was recorded
Time frame: 1 day
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Bing, doctor study director
Endocrine Department, the south west Hospital of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Two-Dimensional Echocardiography, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wu Qinan, master (13452867542, wqn11@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the gender, height, weight, blood pressure, course of the disease of each patient was recorded (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2011.