Study on effect of BCG vaccination on immune markers of type 1 diabetes.
Not Applicable
- Conditions
- Health Condition 1: E108- Type 1 diabetes mellitus with unspecified complications
- Registration Number
- CTRI/2019/03/017942
- Lead Sponsor
- Department of Pediatrics PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Mean fasting and mean blood sugar level over previous 7 days, <br/ ><br>Dose of insulin (U/kg/day), Plasma HbA1C and fasting C-peptide levels <br/ ><br>Timepoint: Baseline and 6 months