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

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.

Study Overview

• Status: Unknown
• Conditions: Diastolic Dysfunction

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 Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage of Frequency of asymptomatic left ventricular diastolic dysfunction in diabetes mellitus type 2	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: May 6, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): June 23, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: diastolic dysfunction
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: assiut university9000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No