Effect of Coenzyme Q10 on Diabetic Children

Assiut University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT06361680

Coenzyme Q10 on diabetic child

Details and patient eligibility

About

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

Full 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 .

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group A

Experimental group

Description:

Will take Coenzyme Q10 soft gel capsules or tablets in a dose of 100-200mg of natural factors

Treatment:

Drug: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets

Group B

Experimental group

Description:

Will not take Coenzyme Q10 soft gel capsules or tablets

Treatment:

Drug: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets