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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03196687
Other study ID # assiut university9000
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 6, 2017
Last updated June 22, 2017
Start date July 1, 2017
Est. completion date June 1, 2018

Study information

Verified date May 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- DM type 2 who are asymptomatic of any cardiac symptom.

Exclusion Criteria:

- Patients of known hypertension with or without treatment.

- Cardiac arrhythmias.

- Cardiomyopathy.

- Valvular heart disease.

- Heart failure.

- Chronic pulmonary disease.

- Extreme age.

- Chronic renal failure.

- Subjects with poor transthoracic echo window.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary percentage of Frequency of asymptomatic left ventricular diastolic dysfunction in diabetes mellitus type 2 1 year
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