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A cross sectional, case-controlled trial to study the relationship between moderately controlled Type 1 diabetes (HBA1C = 8-9.5) and cognition levels to gut microbiome profile compared to age matched healthy controls

Project Overview

The partner institutes for this project are Hirabai Cowasji Jehangir Medical Research Institute (HCJMRI), Pune & KMCH Research Foundation, Coimbatore. Type 1 diabetes mellitus (T1DM) is an auto-immune disorder that occurs in a genetically susceptible individual due to certain environmental triggers resulting in the destruction of insulin-secreting pancreatic cells. According to a recent report, India is ranked 59th in the world with an incidence of 4.2 T1DM cases per 100,000 populations (IDF, 2021).


HCJMRI

Hundred and thirty-one children diagnosed with T1DM and 79 healthy children have been enrolled by HCJMRI as participants for the study. Data entry has been completed for all enrolled participants, while data compilation is in process. Additionally, blood and stool samples for a total of 210 children have been collected. 210 stool samples have been submitted to SKAN Research Trust for microbiome analysis. Enrolment of 20 subjects with T1DM and 1 healthy control as subjects is yet to be done. Researchers from KMCH Research Foundation, Coimbatore have been provided training on data collection procedure and administration of cognition testing. More than 50% data collection has been achieved.


KMCH Research Foundation

120 children with type 1 diabetes were pre-identified and received oral consent from both the children and their parents by KMCH Research Foundation for participation in the study. The written informed consent will be obtained during enrolment and sample collection. The team traveled to Jehangir Medical Research Institute to receive training in performing the BKT test for cognitive testing. Further, it will be ensured that all procedures including data collection, blood anthropometry, and sample collection are being performed in a coordinated manner. Samples collection has started after performing the BKT test. Until now, 35 samples have been collected from children with T1DM condition. The process of identifying the age and sex-matched healthy controls for this study is underway. Data and sample collection has been completed for 35 children diagnosed with T1DM.