Diabetes Mellitus, Type 1NCT03660293
Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardioprotective Drugs
A study testing Atorvastatin, Captopril and L-carnitine in people with Diabetes Mellitus, Type 1, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Atorvastatin, Captopril and L-carnitine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children and adolescent suffering from type 1 Diabetes Mellitus, for at least 3 years from the onset of the disease.
Who cannot join
- Children with Congenital Heart Diseases.
- Children with acquired cardiac diseases.
- Children with other systemic diseases.
- Symptomatic diabetic cardiomyopathy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine- Tanta University
Tanta, Gharbia Governorate, 0000
About this study
Official title: Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardio-protective Drugs
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). There is a possible cardioprotective effect of statins, Captopril and L-Carnitine in type 1 diabetic children and adolescents.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Atorvastatin, Captopril, L-carnitine
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
cardio-protective agents
CaptoprilDrug
cardio-protective agents
L-carnitineDrug
cardio-protective agents
| Study group | Role | What they receive |
|---|---|---|
| diabetic- no cardioprotectives | No intervention | 25 child with type 1 diabetes mellitus will not receive any cardio protective drug |
| diabetic-Atorvastatin | Experimental | 25 child with type 1 diabetes mellitus will receive Statin (2 mg/kg/day) Receives: Drug: Atorvastatin |
| diabetic-Captopril | Experimental | 25 child with type 1 diabetes mellitus will receive Captopril (0.2 mg/kg/day) Receives: Drug: Captopril |
| diabetic-L-Carnitine | Experimental | 25 child with type 1 diabetes mellitus will receive L-carnitine (50 mg/kg/day) Receives: Drug: L-carnitine |
| Controls | No intervention | 50 healthy children, of matched age and sex, with no symptoms of cardiac diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents.
Corrected QT interval(QTc) and QT dispersion in ElectroCardioGram
Measured: 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.
Left Ventricular End Systolic Volume (ml). Left Ventricular End Diastolic Volume (ml). Ejection Fraction (EF %) and left ventricular strain using echocardiography.
Measured: before and after 4 months of receiving cardio-protective agents
Secondary outcomes (3)
The role of Troponin I levels as a cardiac marker for detection of asymptomatic cardiovascular insult in diabetic children.
Serum Cardiac troponin I by Enzyme Linked ImmunoSorbant Assay
Measured: first day
The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction
Echocardiography
Measured: first day
Identification of risk factors for developing diabetic cardiac insult.
Measured: first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Apr 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Mohamed Gamal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660293
- Sponsor's protocol ID
- 31499/04/17
- Status last verified
- Sep 2018
- First submitted
- 11 Jul 2018
- Last updated
- 17 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Badreldeen A, El Razaky O, Erfan A, El-Bendary A, El Amrousy D. Comparative study of the efficacy of captopril, simvastatin, and L-carnitine as cardioprotective drugs in children with type 1 diabetes mellitus: a randomised controlled trial. Cardiol Young. 2021 Aug;31(8):1315-1322. doi: 10.1017/S1047951121000226. Epub 2021 Feb 4.
PubMed 33536102
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardio-protective Drugs
- ClinicalTrials.gov ID
- NCT03660293
- Acronym / sponsor ID
- 31499/04/17
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). There is a possible cardioprotective effect of statins, Captopril and L-Carnitine in type 1 diabetic children and adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| diabetic- no cardioprotectives | No intervention | –25 child with type 1 diabetes mellitus will not receive any cardio protective drug |
| diabetic-Atorvastatin | Experimental | Drug: Atorvastatin25 child with type 1 diabetes mellitus will receive Statin (2 mg/kg/day) |
| diabetic-Captopril | Experimental | Drug: Captopril25 child with type 1 diabetes mellitus will receive Captopril (0.2 mg/kg/day) |
| diabetic-L-Carnitine | Experimental | Drug: L-carnitine25 child with type 1 diabetes mellitus will receive L-carnitine (50 mg/kg/day) |
| Controls | No intervention | –50 healthy children, of matched age and sex, with no symptoms of cardiac diseases |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children and adolescent suffering from type 1 Diabetes Mellitus, for at least 3 years from the onset of the disease.
Key exclusion criteria (4 listed)
- Children with Congenital Heart Diseases.
- Children with acquired cardiac diseases.
- Children with other systemic diseases.
- Symptomatic diabetic cardiomyopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatincardio-protective agents | Drug | diabetic-Atorvastatin |
| Captoprilcardio-protective agents | Drug | diabetic-Captopril |
| L-carnitinecardio-protective agents | Drug | diabetic-L-Carnitine |
Primary outcome
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
Corrected QT interval(QTc) and QT dispersion in ElectroCardioGram
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
Left Ventricular End Systolic Volume (ml). Left Ventricular End Diastolic Volume (ml). Ejection Fraction (EF %) and left ventricular strain using echocardiography.
3 secondary outcomes
The role of Troponin I levels as a cardiac marker for detection of asymptomatic cardiovascular insult in diabetic children.
Time frame: first day
The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction
Time frame: first day
Identification of risk factors for developing diabetic cardiac insult.
Time frame: first day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Derived from this study: PubMed 33536102Badreldeen A, El Razaky O, Erfan A, El-Bendary A, El Amrousy D. Comparative study of the efficacy of captopril, simvastatin, and L-carnitine as cardioprotective drugs in children with type 1 diabetes mellitus: a randomised controlled trial. Cardiol Young. 2021 Aug;31(8):1315-1322. doi: 10.1017/S1047951121000226. Epub 2021 Feb 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin, Captopril and L-carnitine in people with Diabetes Mellitus, Type 1, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03660293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.