Diastolic DysfunctionNCT03196687
Frequency of Asymptomatic Left Ventricular Diastolic Dysfunction in Diabetes Mellitus Type 2
An observational study of Diastolic Dysfunction, run by Assiut University.
Trial summary
Patients with type 2 DM may develop a cardiomyopathy often called diabetic cardiomyopathy which is characterized by left ventricular diastolic dysfunction in early stages Type 2 DM is associated with various types of subclinical target organ damage resulting in elevated risk of CVD events, moreover there is growing… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diastolic Dysfunction
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Jun 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Will assess the prevelance and frequency of diastolic dysfunction of the left ventricle in patients with asymptomatic type 2 DM and to explore its relation to other parameters, including patients' age, sex, the duration of diabetes and glycemic control.
Who may be able to join
- DM type 2 who are asymptomatic of any cardiac symptom.
Who cannot join
- Patients of known hypertension with or without treatment.
- Cardiac arrhythmias.
- Cardiomyopathy.
- Valvular heart disease.
- Heart failure.
- Chronic pulmonary disease.
Show all 9Show fewer
- Extreme age.
- Chronic renal failure.
- Subjects with poor transthoracic echo window.
About this study
Patients with type 2 DM may develop a cardiomyopathy often called diabetic cardiomyopathy which is characterized by left ventricular diastolic dysfunction in early stages
Type 2 DM is associated with various types of subclinical target organ damage resulting in elevated risk of CVD events, moreover there is growing evidence that a prediabetic status, such as impaired fasting glucose is also related to subclinical target organ damage when compared to a group with normal glucose metabolism Diabetes mellitus is a well-studied major risk factor for coronary heart diseases, which is one of the leading causes of death worldwide. Another distinct entity of diabetes-related cardiac affection is the diabetic cardiomyopathy. This entity of cardic affection by diabetes still needs more and more attention, not only because it is common in diabetic patients, but also because of its easy detection by the simple, inexpensive and widely available diagnostic echocardiography.
Read the detailed description
Patients with type 2 DM may develop a cardiomyopathy often called diabetic cardiomyopathy which is characterized by left ventricular diastolic dysfunction in early stages
Type 2 DM is associated with various types of subclinical target organ damage resulting in elevated risk of CVD events, moreover there is growing evidence that a prediabetic status, such as impaired fasting glucose is also related to subclinical target organ damage when compared to a group with normal glucose metabolism
Diabetes mellitus is a well-studied major risk factor for coronary heart diseases, which is one of the leading causes of death worldwide. Another distinct entity of diabetes-related cardiac affection is the diabetic cardiomyopathy. This entity of cardic affection by diabetes still needs more and more attention, not only because it is common in diabetic patients, but also because of its easy detection by the simple, inexpensive and widely available diagnostic echocardiography.
The proposed mechanisms that may be implicated in the pathogenesis of diabetic cardiomyopathy include autonomic dysfunction, microvascular disease, interstitial fibrosis and metabolic disorders. However, the actual causes and mechanisms remain unclear.
- Conditions
- Diastolic Dysfunction
- Keywords
- diastolic dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of Frequency of asymptomatic left ventricular diastolic dysfunction in diabetes mellitus type 2
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mena samwel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196687
- Sponsor's protocol ID
- assiut university9000
- Status last verified
- May 2017
- First submitted
- 6 May 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study will assess the prevelancea and frequency of diastolic dysfunction of the left ventricle in patients with asymptomatic type 2 DM and to explore its relation to other parameters, including patients' age, sex, the duration of diabetes and glycemic control.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Asymptomatic Left Ventricular Diastolic Dysfunction in Diabetes Mellitus Type 2
- ClinicalTrials.gov ID
- NCT03196687
- Acronym / sponsor ID
- assiut university9000
- Conditions
- Diastolic Dysfunction
- Keywords
- diastolic dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 23 Jun 2017 (actual)
- 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.
Patients with type 2 DM may develop a cardiomyopathy often called diabetic cardiomyopathy which is characterized by left ventricular diastolic dysfunction in early stages
Type 2 DM is associated with various types of subclinical target organ damage resulting in elevated risk of CVD events, moreover there is growing evidence that a prediabetic status, such as impaired fasting glucose is also related to subclinical target organ damage when compared to a group with normal glucose metabolism Diabetes mellitus is a well-studied major risk factor for coronary heart diseases, which is one of the leading causes of death worldwide. Another distinct entity of diabetes-related cardiac affection is the diabetic cardiomyopathy. This entity of cardic affection by diabetes still needs more and more attention, not only because it is common in diabetic patients, but also because of its easy detection by the simple, inexpensive and widely available diagnostic echocardiography.
Detailed description
Patients with type 2 DM may develop a cardiomyopathy often called diabetic cardiomyopathy which is characterized by left ventricular diastolic dysfunction in early stages
Type 2 DM is associated with various types of subclinical target organ damage resulting in elevated risk of CVD events, moreover there is growing evidence that a prediabetic status, such as impaired fasting glucose is also related to subclinical target organ damage when compared to a group with normal glucose metabolism
Diabetes mellitus is a well-studied major risk factor for coronary heart diseases, which is one of the leading causes of death worldwide. Another distinct entity of diabetes-related cardiac affection is the diabetic cardiomyopathy. This entity of cardic affection by diabetes still needs more and more attention, not only because it is common in diabetic patients, but also because of its easy detection by the simple, inexpensive and widely available diagnostic echocardiography.
The proposed mechanisms that may be implicated in the pathogenesis of diabetic cardiomyopathy include autonomic dysfunction, microvascular disease, interstitial fibrosis and metabolic disorders. However, the actual causes and mechanisms remain unclear.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Will assess the prevelance and frequency of diastolic dysfunction of the left ventricle in patients with asymptomatic type 2 DM and to explore its relation to other parameters, including patients' age, sex, the duration of diabetes and glycemic control.
Key inclusion criteria (1 listed)
- DM type 2 who are asymptomatic of any cardiac symptom.
Key exclusion criteria (9 listed)
- Patients of known hypertension with or without treatment.
- Cardiac arrhythmias.
- Cardiomyopathy.
- Valvular heart disease.
- Heart failure.
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
percentage of Frequency of asymptomatic left ventricular diastolic dysfunction in diabetes mellitus type 2
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Individual participant dataSharing planned: Undecided. This study will assess the prevelancea and frequency of diastolic dysfunction of the left ventricle in patients with asymptomatic type 2 DM and to explore its relation to other parameters, including patients' age, sex, the duration of diabetes and glycemic control.
Related trials for Diastolic Dysfunction
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
Recruiting
Optimised Cardiovascular and Renal Protection in Patients With Chronic Kidney Disease and Cardiovascular Disease
Chronic Kidney Disease, Heart Failure With Preserved Ejection Fraction (HFPEF)
Not yet recruitingObservational study
Changes in Intramyocardial Fat Assessed by Cardiac CT Before and After Bariatric Surgery and Their Relationship With Cardiac Diastolic Function
Obesity, Diastolic Dysfunction
Active, not recruitingObservational study
Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study
HIV Infections
Not yet recruiting
Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients
Hypertension, Left Ventricular Diastolic Dysfunction
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diastolic Dysfunction, run by Assiut University.
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 1 inclusion and 9 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 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of Frequency of asymptomatic left ventricular diastolic dysfunction in diabetes mellitus type 2 (time frame: 1 year). 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 23 Jun 2017.