Type 1 Diabetes MellitusEarly Phase 1NCT06361680
Effect of Coenzyme Q10 on Diabetic Children
A Early Phase 1 study testing Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets in people with Type 1 Diabetes Mellitus, run by Assiut University.
Trial summary
Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 30 Nov 2025
- Phase
- Early Phase 1
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients diagnosed as type 1 diabetes mellitus from age of 2 years old to 18 years old with diabetes mellitus of duration at least 1 year.
Who cannot join
- - patients diagnosed as diabetes mellitus less than 2 years old .
- patients with diabetes mellitus of duration less than 1 year.
- patients diagnosed as type 1 diabetes mellitus with Thyroid or celiac diseases.
- other types of hyperglycemia rather than Type 1 diabetes mellitus.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Coenzyme Q10 Supplementation on Metabolic Control in Children With Type 1 Diabetes Mellitus: a Randomized Clinical Trial
Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin
Read the detailed description
Type 1 diabetes mellitus is an autoimmune disease that leads to destruction of insulin producing pancreatic Beta cells.
Individuals with type 1 diabetes requires life long insulin replacement with multiple daily insulin injection. daily,insulin pump therapy or the use of an automated insulin delivery system.
without insulin ,diabetic ketoacidosis develops and is life threatening.
In addition to insulin Therapy ,glucose monitoring with a continuous glucose monitor and a blood glucose monitor if continuous glucose monitor is unavailable is recommended .
Coenzyme Q10 supplementation has beneficial effects on glycemic control especially in diabetes , and 100-200 mg per day of Co Q10 could achieve the greatest benefit which could provide a basis for the dietary guidelines of Co Q10 in patients with glycemic disorders .
Co Q10 with a known antiinflammatory and antioxidant has beneficial effects on endothelial function and therefore minimize the microvascular and macrovascular complication in patients with type 1 diabetes mellitus.
Administration of Co Q10 for 3 months in type 1 diabetes mellitus in pediatric patients was will tolerated but had no favorable effect on endothelial dysfunction or metabolic parameters .
Co Q10 in addition to improving the metabolic hyperglycemia , it improve Hb A1c and the lipid profile.
patients with type 1 diabetes , especially poorly controlled had elevation of plasma vitamin E and coenzyme Q10 levels and decreased platelet redox status of coenzyme Q10 which may be an indicator of increased oxidative stress ,so Co Q10 has an antioxidant effects.
Researches on this topic are limited on pediatrics and investigators search for it and will see the result.(clinical trial)
Co Q10 is present in the forms of soft gel capsules ,oral spray , hard gel capsules and tablets .
Co Q10 approved from age of 2 years old to 18 years old .
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets
- 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 Q10 Cap/Tab as natural factors capsules or kirkman tabletsDrug
Also called Natural factors capsules or Kirkman tablets
Group A will take Soft gel capsules or tablets of Coenzyme Q10 in a dose of 100-200mg of natural factors or kirkman but group B will not take Coenzyme Q10 just observe them
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Will take Coenzyme Q10 soft gel capsules or tablets in a dose of 100-200mg of natural factors Receives: Drug: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets |
| Group B | Experimental | Will not take Coenzyme Q10 soft gel capsules or tablets Receives: Drug: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus
This prospective randomized clinical trial will be conducted on 100 participants . Half of them will not receive treatment but group A will receive 100-200mg of Coenzyme Q10 . the level of glycated hemoglobin, fasting blood glucose will be assessed for both groups at baseline and after 3 months of treatment for ongoing use in diabetic children
Measured: One year
Secondary outcomes (1)
Control of random blood sugar and glycated haemoglobin in children with type 1 diabetes mellitus .
By ensuring of regular intake of Coenzyme Q10 capsules or tablets then assessment of glycated hemoglobin
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Saad Abdel Malak Abdel Nour, Assiut University
- Investigators
- Christina Saad Abdel Malak Abdel Nour, Principal investigator, Study producer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361680
- Sponsor's protocol ID
- Coenzyme Q10 on diabetic child
- Status last verified
- Apr 2024
- First submitted
- 15 Mar 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serag H, El Wakeel L, Adly A. Coenzyme Q10 administration has no effect on sICAM-1 and metabolic parameters of pediatrics with type 1 diabetes mellitus. Int J Vitam Nutr Res. 2021 Jun;91(3-4):315-324. doi: 10.1024/0300-9831/a000636. Epub 2020 Jan 16.
PubMed 31942840Sangouni AA, Taghdir M, Mirahmadi J, Sepandi M, Parastouei K. Effects of curcumin and/or coenzyme Q10 supplementation on metabolic control in subjects with metabolic syndrome: a randomized clinical trial. Nutr J. 2022 Oct 3;21(1):62. doi: 10.1186/s12937-022-00816-7.
PubMed 36192751Liang Y, Zhao D, Ji Q, Liu M, Dai S, Hou S, Liu Z, Mao Y, Tian Z, Yang Y. Effects of coenzyme Q10 supplementation on glycemic control: A GRADE-assessed systematic review and dose-response meta-analysis of randomized controlled trials. EClinicalMedicine. 2022 Aug 3;52:101602. doi: 10.1016/j.eclinm.2022.101602. eCollection 2022 Oct.
PubMed 35958521Stojanovic M, Radenkovic M. A meta-analysis of randomized and placebo-controlled clinical trials suggests that coenzyme Q10 at low dose improves glucose and HbA1c levels. Nutr Res. 2017 Feb;38:1-12. doi: 10.1016/j.nutres.2016.12.001. Epub 2016 Dec 8.
PubMed 28381349Salardi S, Zucchini S, Elleri D, Grossi G, Bargossi AM, Gualandi S, Santoni R, Cicognani A, Cacciari E. High glucose levels induce an increase in membrane antioxidants, in terms of vitamin E and coenzyme Q10, in children and adolescents with type 1 diabetes. Diabetes Care. 2004 Feb;27(2):630-1. doi: 10.2337/diacare.27.2.630. No abstract available.
PubMed 14747266
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Coenzyme Q10 Supplementation on Metabolic Control in Children With Type 1 Diabetes Mellitus: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06361680
- Acronym / sponsor ID
- Coenzyme Q10 on diabetic child
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 12 Apr 2024 (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.
Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin
Detailed description
Type 1 diabetes mellitus is an autoimmune disease that leads to destruction of insulin producing pancreatic Beta cells.
Individuals with type 1 diabetes requires life long insulin replacement with multiple daily insulin injection. daily,insulin pump therapy or the use of an automated insulin delivery system.
without insulin ,diabetic ketoacidosis develops and is life threatening.
In addition to insulin Therapy ,glucose monitoring with a continuous glucose monitor and a blood glucose monitor if continuous glucose monitor is unavailable is recommended .
Coenzyme Q10 supplementation has beneficial effects on glycemic control especially in diabetes , and 100-200 mg per day of Co Q10 could achieve the greatest benefit which could provide a basis for the dietary guidelines of Co Q10 in patients with glycemic disorders .
Co Q10 with a known antiinflammatory and antioxidant has beneficial effects on endothelial function and therefore minimize the microvascular and macrovascular complication in patients with type 1 diabetes mellitus.
Administration of Co Q10 for 3 months in type 1 diabetes mellitus in pediatric patients was will tolerated but had no favorable effect on endothelial dysfunction or metabolic parameters .
Co Q10 in addition to improving the metabolic hyperglycemia , it improve Hb A1c and the lipid profile.
patients with type 1 diabetes , especially poorly controlled had elevation of plasma vitamin E and coenzyme Q10 levels and decreased platelet redox status of coenzyme Q10 which may be an indicator of increased oxidative stress ,so Co Q10 has an antioxidant effects.
Researches on this topic are limited on pediatrics and investigators search for it and will see the result.(clinical trial)
Co Q10 is present in the forms of soft gel capsules ,oral spray , hard gel capsules and tablets .
Co Q10 approved from age of 2 years old to 18 years old .
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tabletsWill take Coenzyme Q10 soft gel capsules or tablets in a dose of 100-200mg of natural factors |
| Group B | Experimental | Drug: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tabletsWill not take Coenzyme Q10 soft gel capsules or tablets |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients diagnosed as type 1 diabetes mellitus from age of 2 years old to 18 years old with diabetes mellitus of duration at least 1 year.
Key exclusion criteria (4 listed)
- - patients diagnosed as diabetes mellitus less than 2 years old .
- patients with diabetes mellitus of duration less than 1 year.
- patients diagnosed as type 1 diabetes mellitus with Thyroid or celiac diseases.
- other types of hyperglycemia rather than Type 1 diabetes mellitus.
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 Q10 Cap/Tab as natural factors capsules or kirkman tabletsAlso: Natural factors capsules or Kirkman tabletsGroup A will take Soft gel capsules or tablets of Coenzyme Q10 in a dose of 100-200mg of natural factors or kirkman but group B will not take Coenzyme Q10 just observe them | Drug | Group A, Group B |
Primary outcome
Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus
Time frame: One year
This prospective randomized clinical trial will be conducted on 100 participants . Half of them will not receive treatment but group A will receive 100-200mg of Coenzyme Q10 . the level of glycated hemoglobin, fasting blood glucose will be assessed for both groups at baseline and after 3 months of treatment for ongoing use in diabetic children
1 secondary outcome
Control of random blood sugar and glycated haemoglobin in children with type 1 diabetes mellitus .
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Background: PubMed 31942840Serag H, El Wakeel L, Adly A. Coenzyme Q10 administration has no effect on sICAM-1 and metabolic parameters of pediatrics with type 1 diabetes mellitus. Int J Vitam Nutr Res. 2021 Jun;91(3-4):315-324. doi: 10.1024/0300-9831/a000636. Epub 2020 Jan 16.
- Background: PubMed 36192751Sangouni AA, Taghdir M, Mirahmadi J, Sepandi M, Parastouei K. Effects of curcumin and/or coenzyme Q10 supplementation on metabolic control in subjects with metabolic syndrome: a randomized clinical trial. Nutr J. 2022 Oct 3;21(1):62. doi: 10.1186/s12937-022-00816-7.
- Background: PubMed 35958521Liang Y, Zhao D, Ji Q, Liu M, Dai S, Hou S, Liu Z, Mao Y, Tian Z, Yang Y. Effects of coenzyme Q10 supplementation on glycemic control: A GRADE-assessed systematic review and dose-response meta-analysis of randomized controlled trials. EClinicalMedicine. 2022 Aug 3;52:101602. doi: 10.1016/j.eclinm.2022.101602. eCollection 2022 Oct.
- Background: PubMed 28381349Stojanovic M, Radenkovic M. A meta-analysis of randomized and placebo-controlled clinical trials suggests that coenzyme Q10 at low dose improves glucose and HbA1c levels. Nutr Res. 2017 Feb;38:1-12. doi: 10.1016/j.nutres.2016.12.001. Epub 2016 Dec 8.
- Background: PubMed 14747266Salardi S, Zucchini S, Elleri D, Grossi G, Bargossi AM, Gualandi S, Santoni R, Cicognani A, Cacciari E. High glucose levels induce an increase in membrane antioxidants, in terms of vitamin E and coenzyme Q10, in children and adolescents with type 1 diabetes. Diabetes Care. 2004 Feb;27(2):630-1. doi: 10.2337/diacare.27.2.630. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Christina Saad Abdel Malak Abdel Nour principal investigator
Study producer
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets in people with Type 1 Diabetes Mellitus, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faisal Alkhateeb Ahmad Abdullah, Professor (01003858676, faisalalkhateeb@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus (time frame: One year). 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 NCT06361680, which also lists 5 linked publications.
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 12 Apr 2024.