ClinicalTrials.gg
Status unknownNCT03196687Updated Jun 23, 2017

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

An observational study in Diastolic Dysfunction, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-23.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Diastolic Dysfunction

Keywords

  • diastolic dysfunction
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2017; primary completion for Jun 2018, 11 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2017
First posted
Jun 23, 2017
StartEst.
Jul 1, 2017
Primary completionEst.
Jun 1, 2018
CompletionEst.
Jun 1, 2018
Last update
Jun 23, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03196687
Lead sponsor
Assiut University
Responsible party
Mena samwel (Assiut University, Assiut University) — Principal investigator
First posted
Jun 23, 2017
Start date
Jul 1, 2017 (estimated)
Primary completion
Jun 1, 2018 (estimated)
Completion
Jun 1, 2018 (estimated)
Last update
Jun 23, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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