Health Condition 1: E108- Type 1 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: BCG Vaccine: Two doses of BCG vaccine,0.1 ml (0.2-0.8 million CFU
diluent Sodium Chloride Injection IP) intradermal,one month apart will be given to Cases
Control Intervention1: Normal Sline (Placebo): Dose 0.1 ml intradermally 2 doses 1 month apart in Control group
Sponsors
Department of Pediatrics PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children with new-onset type 1 diabetes mellitus (diagnosed in the last 6 months) 2. BCG mark present in the left deltoid 3. Enrolled in pediatric diabetes clinic for follow-up at PGIMER, Chandigarh 4. A parent or legal guardian giving informed consent for the study. 5. One of the antibodies associated with T1DM (GAD 65 or IA2 or IAA) should be positive.
Exclusion criteria
Exclusion criteria: 1. Any known immunodeficiency 2. Active Tuberculosis 3. Past history of Tuberculosis 4. Any known chronic systemic disorder(liver/kidney/ heart) 5. Any genetic syndrome known to affect the immune system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma T-regulatory cell count, Tumor Necrosis Factor, Interleukin-10, Interleukin-17, glutamic acid decarboxylase (GAD65), Insulin Auto-antibodies (IAA),Insulinoma Associated Auto-antigen 2(IA2)assaysTimepoint: Baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean fasting and mean blood sugar level over previous 7 days, Dose of insulin (U/kg/day), Plasma HbA1C and fasting C-peptide levels Timepoint: Baseline and 6 months | — |
Countries
India
Contacts
Public ContactAlisha Babbar
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed