Effect of Coenzyme Q10 on Diabetic Children

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Efficacy of Coenzyme Q10 Supplementation on Metabolic Control in Children With Type 1 Diabetes Mellitus: a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06361680
• Other study ID #: Coenzyme Q10 on diabetic child
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: October 30, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: Faisal Alkhateeb Ahmad Abdullah, Professor
• Phone: 01003858676
• Email: faisalalkhateeb[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Coenzyme Q10 Cap/Tab as 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One year
Secondary	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	One year