NCT03196687

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 23, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

May 6, 2017

Last Update Submit

June 22, 2017

Conditions

Keywords

diastolic dysfunction

Outcome Measures

Primary Outcomes (1)

  • percentage of Frequency of asymptomatic left ventricular diastolic dysfunction in diabetes mellitus type 2

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assiut University

Study Record Dates

First Submitted

May 6, 2017

First Posted

June 23, 2017

Study Start

July 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 23, 2017

Record last verified: 2017-05