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NCT07164768: DMBCOG
Cognitive Function and Mental Health in Children and Youth With Type 1 Diabetes (T1D)
trial in Type 1 Diabetes (T1D) in 400 participants. Enrolling by invitation.
25 June 2027
Quick facts
| Lead sponsor | Hirabai Cowasji Jehangir Medical Research Institute |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 25 June 2024 |
| Primary completion | 25 June 2027 |
| Estimated completion | 25 June 2027 |
| Sites | 1 location across India |
Conditions studied
- Type 1 Diabetes (T1D) — all drugs for Type 1 Diabetes (T1D) →
Sponsor
Hirabai Cowasji Jehangir Medical Research Institute
Who can join
Adults 10 to 21, any sex, with Type 1 Diabetes (T1D). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07164768
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07164768 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hirabai Cowasji Jehangir Medical Research Institute
- Last refreshed: 10 September 2025
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