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Cognitive Function and Mental Health in Children and Youth With Type 1 Diabetes (T1D)

NCT07164768 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-09-10

No results posted yet for this study

Summary

The Hirabai Cowasji Jehangir Medical Research Institute (HCJMRI), Pune, a Center of Excellence in type 1 diabetes (T1D), has extensive experience in studying prospective cohorts with high follow-up rates. HCJMRI maintains a registry of over 800 children with T1D, systematically assessing their glycemic control and diabetes-related complications.

Given the high prevalence of T1D in India and the lack of studies on Indian children with T1D, the investigators aim to investigate cognitive function and mental health in children and youth with T1D compared to healthy controls, exploring key determinants of these outcomes.

The investigators propose a cross-sectional, observational, case-control study involving children and youth aged 10-21 years with T1D and age- and gender-matched healthy controls from similar socio-economic backgrounds. Participants will be enrolled between July 2023 and July 2025, with assent from children and consent from parents. Those with neurodevelopmental disorders will be excluded. The investigators plan to recruit one in two eligible participants with T1D from our existing cohort, with a total sample size of 396 participants (264 cases and 132 controls), adequately powered to detect group differences with a moderate effect size.

Data on T1D exposure will be extracted from ongoing cohort records. Outcomes assessed in both groups include:

1. Cognitive functions - assessed using age-appropriate tests.
2. Behavioral and emotional problems - evaluated in children, adolescents, and young adults.
3. Quality of life - assessed using standardized tools. Potential confounders such as age, gender, socio-economic status, parental education, occupation, participant's education, and pubertal status will be considered. Random blood samples will be collected at the time of cognitive testing to measure plasma glucose, HbA1c, and Human-BDNF levels, examining associations between glycemic control and cognitive outcomes. Additionally, annual checkup data will be used to explore the impact of T1D complications on cognitive function.

Group differences in outcomes will be analyzed using ANCOVA while controlling for covariates. Regression models will assess cognitive function as a function of T1D exposure, adjusting for mediators and modifiers.

This will be one of the first studies in India to systematically examine multiple cognitive domains in a large T1D sample across a broad age range (10-21 years). Findings will enhance understanding of T1D's impact on cognitive development in an Indian context, where undernutrition is common, and T1D prevalence is rising.

Keywords: Type 1 diabetes, children, cognitive function, behavioral and emotional problems, quality of life.

Conditions

  • Type 1 Diabetes (T1D)

Sponsors & Collaborators

  • Hirabai Cowasji Jehangir Medical Research Institute

    lead OTHER

Principal Investigators

  • Dr. Sonali S Wagle, M.Sc, RD, PhD · Hirabai Cowasji Jehangir Medical Research Institute, Pune, India

Eligibility

Min Age
10 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2027-06-25
Completion
2027-06-25

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164768 on ClinicalTrials.gov