Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361680
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-15
Brief Title:
Effect of Coenzyme Q10 on Diabetic Children
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Efficacy of Coenzyme Q10 Supplementation on Metabolic Control in Children With Type 1 Diabetes Mellitus a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dailyinsulin 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 resultclinical 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
Individuals with type 1 diabetes requires life long insulin replacement with multiple daily insulin injection dailyinsulin 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 resultclinical 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None