Clinical trial NCT06361680: Effect of Coenzyme Q10 on Diabetic Children
Official title: Efficacy of Coenzyme Q10 Supplementation on Metabolic Control in Children With Type 1 Diabetes Mellitus: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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 .

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* - 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.

Primary outcomes:
measure: Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus
timeFrame: One year
Secondary outcomes:
measure: Control of random blood sugar and glycated haemoglobin in children with type 1 diabetes mellitus .
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Study producer
name: Christina Saad Abdel Malak Abdel Nour
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sangouni 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.
citation: Liang 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.
citation: Stojanovic 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.
citation: Salardi 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.