Health Condition 1: O- Medical and Surgical Health Condition 2: E109- Type 1 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Hydroxychloroquine sulphate: Arm 1: HCQS 3 mg/Kg/day for 6 months
Intervention2: Arm 1: Hydroxychloroquine sulphate: HCQS 3 mg/Kg/day for 6 months
Control Intervention1: Placebo arm: Ar
Sponsors
Post Graduate Institute of Medical Education and Research PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with type 1 diabetes mellitus between 8 and 18 years. AND 2. Detected to have type 1 diabetes mellitus in the last 100 days. AND 3. Informed consent for the study given by parent or a legal guardian.
Exclusion criteria
Exclusion criteria: Patients with any one of the following will be excluded: 1. Those children who were already started on hydroxychloroquine for a different indication 2. Those who had history of any serious adverse effects/ acute drug reaction after initiation of hydroxychloroquine in the past 3. Patients on medications which can cause drug interactions with hydroxychloroquine 4. Past history of hemolysis due to deficiency of G6PD 5. Proven retinal disease in the past 6. Prolonged QT interval or other known cardiac diseases 7. Any active infections 8. White blood cell counts less than 3000 leukocytes per microlitre, Platelets below 1,25,000/micro litre, absolute neutrophil count below 1500 per micro litre 9. Liver dysfunction (jaundice, elevated alanine aminotransferase or aspartate aminotransferase for more than a week at the time of enrolment) 10. Renal dysfunction 11. Any ECG abnormality
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Difference in serum C-peptide levels (fasting and post-mixed meal). â?¢Improvement in HbA1C levelsTimepoint: 0, 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| a. To look for side effects when using hydroxychloroquine and imatinib in children with T1D. b. To see if hydroxychloroquine plus imatinib therapy results in a reduction in HbA1c, insulin dosage or delivery frequency. c. To see if hydroxychloroquine and imatinib therapy changed the number of regulatory T cells (Tregs) and IL 10 in children with new-onset T1D.Timepoint: 0 and 6 months | — |
Countries
India
Contacts
Public ContactArun George
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed