Diabetes Mellitus, Type 1Phase 2NCT03111433
Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus
A Phase 2 study testing Coenzyme Q10 and Insulin in people with Diabetes Mellitus, Type 1, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to determine wether coenzyme Q10 is effective in reducing markers of endothelial dysfunction in pediatric patients with type 1 diabetes mellitus and aslo to investigate its effect on glycemic control and lipid profile of those patients and its effect on patient's quality of life. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Coenzyme Q10 and Insulin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Mar 2017to 20 Jan 2018
- Phase
- Phase 2
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: patients from 8 to 18 years old.
- Outpatient with at least 1 year history of type 1 diabetes mellitus.
- Insulin requirement of more than or equal 0.5 U/Kg/day.
- Approval to participate and give informed consent.
Who cannot join
- Presence of systemic disorders such as celiac disease, hypothyroidism or hyperthyroidism.
- Preexisting cardiovascular disease or hypertension.
- Chronic kidney disease or chronic liver disease.
- Significant mental illness.
- Intake of other antioxidants such as ascorbic acid and α-tocopherol and omega3 supplement within the last 3 months.
- Intake of coenzyme Q10 within the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Coenzyme Q10 on Markers of Endothelial Dysfunction in Pediatric Patients With Type 1 Diabetes Mellitus
The purpose of this study is to determine wether coenzyme Q10 is effective in reducing markers of endothelial dysfunction in pediatric patients with type 1 diabetes mellitus and aslo to investigate its effect on glycemic control and lipid profile of those patients and its effect on patient's quality of life.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Coenzyme Q10, Insulin
- Keywords
- Type 1 Diabetes mellitus, Coenzyme Q10, endothelial dysfunction, pediatric patients
- 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.
Coenzyme Q10Dietary supplement
Coenzyme Q10 soft gelatin capsule 100mg
InsulinDrug
multiple dose insulin injection therapy
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | this group of patients will receive their standard insulin treatment in addition to 100 mg of coenzyme Q10 soft gelatin capsule once daily for three month Receives: Dietary Supplement: Coenzyme Q10; Drug: Insulin |
| Group II | Active comparator | this group of patients will receive their standard insulin treatment only Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in soluble interacellular adhesion molecule level
it will be assessed at baseline and after three months of treatment
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start19 Mar 2017
- Primary completion20 Jan 2018
- Study completion20 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Ain Shams 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba ibrahim Mohamed serag, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111433
- Sponsor's protocol ID
- PHCL136
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2017
- Last updated
- 3 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coenzyme Q10 on Markers of Endothelial Dysfunction in Pediatric Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03111433
- Acronym / sponsor ID
- PHCL136
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes mellitus, Coenzyme Q10, endothelial dysfunction, pediatric patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 19 Mar 2017 (actual)
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 12 Apr 2017 (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.
The purpose of this study is to determine wether coenzyme Q10 is effective in reducing markers of endothelial dysfunction in pediatric patients with type 1 diabetes mellitus and aslo to investigate its effect on glycemic control and lipid profile of those patients and its effect on patient's quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Dietary Supplement: Coenzyme Q10, Drug: Insulinthis group of patients will receive their standard insulin treatment in addition to 100 mg of coenzyme Q10 soft gelatin capsule once daily for three month |
| Group II | Active comparator | Drug: Insulinthis group of patients will receive their standard insulin treatment only |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age: patients from 8 to 18 years old.
- Outpatient with at least 1 year history of type 1 diabetes mellitus.
- Insulin requirement of more than or equal 0.5 U/Kg/day.
- Approval to participate and give informed consent.
Key exclusion criteria (6 listed)
- Presence of systemic disorders such as celiac disease, hypothyroidism or hyperthyroidism.
- Preexisting cardiovascular disease or hypertension.
- Chronic kidney disease or chronic liver disease.
- Significant mental illness.
- Intake of other antioxidants such as ascorbic acid and α-tocopherol and omega3 supplement within the last 3 months.
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 |
|---|---|---|
| Coenzyme Q10Coenzyme Q10 soft gelatin capsule 100mg | Dietary supplement | Group I |
| Insulinmultiple dose insulin injection therapy | Drug | Group I, Group II |
Primary outcome
change in soluble interacellular adhesion molecule level
Time frame: three months
it will be assessed at baseline and after three months of treatment
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 3 Apr 2018.
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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 Phase 2 study testing Coenzyme Q10 and Insulin in people with Diabetes Mellitus, Type 1, run by Ain Shams 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 4 inclusion and 6 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 3 Apr 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change in soluble interacellular adhesion molecule level (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2018.