Csak meghívásosFázis nélkül

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

A legfontosabb adatok

Ki végzi: Hirabai Cowasji Jehangir Medical Research Institute
Hol: Pune (India)A helyszín megnézése
Azonosító: NCT07164768
Állapot: Csak meghívásos
Résztvevők: 400 fő, tervezett
Kezdés: 2024. jún. 25.
Várható befejezés: 2027. jún. 25.
A vizsgálat típusa: Megfigyeléses
A regiszteradat frissítve: 2025. szeptember 10.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat 1-es típusú cukorbetegségben élő gyerekeket, kamaszokat és fiatal felnőtteket keres, egy szülővel vagy gondozóval együtt. Egészséges, azonos korú és nemű gyerekek és fiatalok is részt vesznek összehasonlító csoportként.

Életkor: 10 Years - 21 Years
Nem: Mindenki részt vehet

A részvétel fő kizáró okai

Olyan gyerek, akinek mindkét szülője nem él
Olyan gyerek, aki nem a szüleivel, hanem a nagyszüleivel él
Idegrendszeri fejlődési zavarral élő gyerek

A regiszter feltételei, szó szerint

Mind a 2 feltétel megnézéseKevesebb

Ki vehet részt

Children, adolescents and young adults with T1D and their parents (caregiver, either mother or father)

Ki nem vehet részt

Both parents are not alive or the child is not living with the parents and living with the grandparents

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

10 és 21 év között vagy?

Helyszínek itt: India

Hirabai Cowasji Jehangir Medical Research InstitutePune, IndiaCsak meghívásos

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat csoportja

Children and youth with type 1 diabetes (T1D) and their parents
The Hirabai Cowasji Jehangir Medical Research Institute (HCJMRI), Pune is a Center of Excellence in type 1 diabetes and has vast experience in studying prospective cohorts with good follow up rates. It also has a registry of more than 800 children with type 1 diabetes with systematic assessment of their glycemic control and micro and macrovascular complications due to type 1 diabetes. We would like to propose a cross sectional, observational, case control study in children with T1D and healthy controls of age 10-21 years (who give assent and parents give consent; children no neurodevelopmental disorders will be enrolled in the study) from similar socio-economic class as the children with diabetes. Approximate period of enrollment will be from July 2023 to July 2025. We expect to recruit one in two of participant with type 1 diabetes from our cohort and age gender matched healthy controls without type 1 diabetes.