Effect of Coenzyme Q10 on Markers of Endothelial Dysfunction in Pediatric Patients With Type 1 Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- change in soluble interacellular adhesion molecule level
Study Overview
Brief Summary
The purpose of this study is to determine wether coenzyme Q10 is effective in reducing markers of endothelial dysfunction in pediatric patients with type 1 diabetes mellitus and aslo to investigate its effect on glycemic control and lipid profile of those patients and its effect on patient's quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: patients from 8 to 18 years old.
- •Outpatient with at least 1 year history of type 1 diabetes mellitus.
- •Insulin requirement of more than or equal 0.5 U/Kg/day.
- •Approval to participate and give informed consent.
Exclusion Criteria
- •Presence of systemic disorders such as celiac disease, hypothyroidism or hyperthyroidism.
- •Preexisting cardiovascular disease or hypertension.
- •Chronic kidney disease or chronic liver disease.
- •Significant mental illness.
- •Intake of other antioxidants such as ascorbic acid and α-tocopherol and omega3 supplement within the last 3 months.
- •Intake of coenzyme Q10 within the last 3 months.
Arms & Interventions
Group I
this group of patients will receive their standard insulin treatment in addition to 100 mg of coenzyme Q10 soft gelatin capsule once daily for three month
Intervention: Coenzyme Q10 (Dietary Supplement)
Group I
this group of patients will receive their standard insulin treatment in addition to 100 mg of coenzyme Q10 soft gelatin capsule once daily for three month
Intervention: Insulin (Drug)
Group II
this group of patients will receive their standard insulin treatment only
Intervention: Insulin (Drug)
Outcomes
Primary Outcomes
change in soluble interacellular adhesion molecule level
Time Frame: three months
it will be assessed at baseline and after three months of treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Heba ibrahim Mohamed serag
teaching assistant in clinical pharmacy department ,faculty of pharmacy , Ainshams university
Ain Shams University