Frequency of Asymptomatic Left Ventricular Diastolic Dysfunction in Diabetes Mellitus Type 2

Diastolic Dysfunction Clinical Trial

Official title:

Frequency of Asymptomatic Left Ventricular Diastolic Dysfunction in Diabetes Mellitus Type 2

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03196687
• Other study ID #: assiut university9000
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diastolic Dysfunction
• Ventricular Dysfunction, Left

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