Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardioprotective Drugs

What Was Tested

In this not phased trial, researchers set out to test L-Carnitine.

Diabetic cardiomyopathy (DCM) is a distinct clinical entity of diabetic heart muscle that describes diabetes associated changes in the structure and function of the myocardium in the absence of coronary artery disease, hypertension, and valvular disease.

Oxidative stress plays a critical role in DCM development.

DCM can be diagnosed using the novel methods of echocardiography (tissue Doppler imaging, Speckling tracking techniques and more recent real time 4D echocardiography).

It had five arms (groups): diabetic- no cardioprotectives (no intervention), diabetic-Atorvastatin (experimental), diabetic-Captopril (experimental), diabetic-L-Carnitine (experimental) and Controls (no intervention).

25 child with type 1 diabetes mellitus will not receive any cardio protective drug.

The registry classes the interventions as drug.

Who Took Part

150 actual participants took part.

It was open to people of any sex aged from 3 years up to 18 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Children and adolescent suffering from type 1 Diabetes Mellitus, for at least 3 years from the onset of the disease.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: children with congenital heart diseases; children with acquired cardiac diseases; children with other systemic diseases.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2017-04-01 with completion listed for 2019-06-01.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents (time frame: before and after 4 months of receiving cardio-protective agents). The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents (time frame: before and after 4 months of receiving cardio-protective agents).

It also tracked 3 secondary outcomes, for example The role of Troponin I levels as a cardiac marker for detection of asymptomatic cardiovascular insult in diabetic children, The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction and Identification of risk factors for developing diabetic cardiac insult.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 150 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.