Type 1 Diabetes Mellitus
Conditions
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 .
Interventions
DRUGCoenzyme 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
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Control of random blood sugar and glycated haemoglobin in children with type 1 diabetes mellitus . | One year | By ensuring of regular intake of Coenzyme Q10 capsules or tablets then assessment of glycated hemoglobin |
Contacts
Primary ContactFaisal Alkhateeb Ahmad Abdullah, Professor
Backup ContactChristina Saad Abdel Malak Abdel Nour
Outcome results
None listed