Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Insulin; Dietary Supplement: Coenzyme Q10

• Registration Number: NCT03111433
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-19
• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-12
• Primary Completion: 2018-01-20
• Study Completion: 2018-01-20
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-01
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Age: patients from 8 to 18 years old.
2. Outpatient with at least 1 year history of type 1 diabetes mellitus.
3. Insulin requirement of more than or equal 0.5 U/Kg/day.
4. Approval to participate and give informed consent.

Exclusion Criteria

1. Presence of systemic disorders such as celiac disease, hypothyroidism or hyperthyroidism.
2. Preexisting cardiovascular disease or hypertension.
3. Chronic kidney disease or chronic liver disease.
4. Significant mental illness.
5. Intake of other antioxidants such as ascorbic acid and α-tocopherol and omega3 supplement within the last 3 months.
6. Intake of coenzyme Q10 within the last 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	Insulin	this group of patients will receive their standard insulin treatment only
Group I	Coenzyme Q10	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
Group I	Insulin	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

Primary Outcome Measures

Name	Time	Method
change in soluble interacellular adhesion molecule level	three months	it will be assessed at baseline and after three months of treatment

Trial Locations

Locations (1)

Ainshams university pediatric's hospital; 🇪🇬 Cairo, Egypt