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临床试验/NCT07164768
NCT07164768Enrolling By Invitation不适用

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

Hirabai Cowasji Jehangir Medical Research Institute1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年6月25日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
400
试验地点
1
主要终点
To assess intelligent quotient (IQ) as a cognitive function in children and youth with type 1 diabetes

研究概览

简要总结

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.

详细描述

Objectives of the project:

  1. To assess cognitive function in children with T1D in comparison with healthy controls and its determinants (parental education and occupation, parenting style and mental health of parents)
  2. To study the association of parental education and occupation, parenting style and mental health of parents with child's glycemic control in children with T1D
  3. To assess the stress, anxiety and depression in children, adolescents and young adults with T1D (10-21 years) in comparison with healthy controls and its impact on their quality of life
  4. Methodology:

Study Subjects:

The 'Sweetlings' programme which is a charity clinic that provides holistic care to underprivileged children and youth with Type 1 Diabetes Mellitus (T1D). Currently, the clinic supports 548 children and youth with T1DM aged 0 to 22 years in the Pune region of the Western Indian State of Maharashtra.

The investigator have 382 children between 6-18 years of age and 103 who are between 18-22 years of age. Siblings of these T1D children will be included as healthy age matched controls for participation in this study. This will ensure about the age matching and also their socioeconomic status and family environment will be similar.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
10 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

To assess intelligent quotient (IQ) as a cognitive function in children and youth with type 1 diabetes

时间窗: 3 years

Age range: 4 to 90 years. Raven's Colored Progressive Matrices: Raven's Progressive Matrices (often referred to simply as Raven's Matrices) to measure general human intelligence and abstract reasoning and is regarded as a non-verbal estimate of fluid intelligence. The Raven's 2 is a nonverbal assessment of general cognitive ability, including the ability to formulate new concepts when faced with novel information, extract meaning out of confusion or ambiguity, and think clearly about complex situation and events. It comprises 60 multiple-choice questions, listed in order of increasing difficulty. This format is designed to measure the test taker's reasoning ability, the eductive ("meaning-making") component of Spearman's g (g is often referred to as general intelligence). It is a measure of verbal and nonverbal generalized cognitive ability.

To assess speed as a cognitive function in children and youth with type 1 diabetes

时间窗: 3 years

Finger-Tapping Test Age Range: 9 years and above Procedure: The test uses an adapted electric finger-tapping instrument and monitor to record the number of taps. The participant taps a mounted key as rapidly as possible using the index finger of the dominant hand, followed by the non-dominant hand. Five consecutive 10-second trials are conducted for each hand. A 30-second break is given after the third trial to minimize fatigue. A practice trial is provided before the test begins. Scoring: The number of taps per 10-second trial is recorded separately for each hand. The mean number of taps across five trials is calculated for each hand. Material: Finger-tapping instrument and stopwatch Duration: 5 minutes

To assess attention as a cognitive function in children and youth with type 1 diabetes

时间窗: 3 years

d2 Test of Attention Age Range: 9-60 years Procedure: The d2 test assesses selective attention and concentration. It can be administered individually or in groups using a single test form. The form includes sections for subject data, test scores, and a practice sample. The standardized test consists of 14 lines, each with 47 characters (total: 658 items). Participants scan each line and cross out all "d's" with two dashes. Each line is timed for 20 seconds. Reliability \& Validity: The test demonstrates high reliability (r \> 0.90) across various indices (TN, TN-E, CP) and is supported by extensive research. Materials: 2 pencils (without erasers) and a stopwatch for the examiner. Duration: 10 minutes

To assess phonemic fluency as an executive function in children with type 1 diabetes

时间窗: 3 years

FAS Test (Children: 5-15 years) - A phonemic fluency test measuring verbal fluency. Participants generate words beginning with F, A, and S (or Ka, Pa, Ma for non-English speakers) within one minute per letter. Proper nouns are excluded. Score: Total admissible words. Duration: \~5 minutes

To assess category fluency as an executive function in children with type 1 diabetes

时间窗: 3 years

Animal Names Test (Children: 5-15 years) - A category fluency test where participants list as many animal names as possible in one minute, excluding fish, birds, and snakes. Score: Total unique words. Duration: \~5 minutes

To assess phonemic fluency as an executive function in adolescents and youth with type 1 diabetes

时间窗: 3 years

COWA Test (Adults: 15-65 years) - A phonemic fluency test where participants generate words beginning with F, A, and S (or Ka, Pa, Ma). Proper nouns and repeated words with different suffixes are excluded. Score: Average new words over three trials. Duration: \~5 minutes

To assess category fluency as an executive function in adolescents and youth with type 1 diabetes

时间窗: 3 years

Category Fluency: Animal Names Test (Adults: 15-65 years) - Same as the children's version, assessing category fluency. Score: Total unique words. Duration: \~5 minutes

To assess working memory as an executive function in children with type 1 diabetes

时间窗: 3 years

Digit \& Letter-Number (WISC) and Processing Speed: Coding \& Symbol Search (WISC) Age Range: 6-16 years Developed in 2003, this scale assesses intellectual ability. The Working Memory Index (WMI) includes Digit Span, Letter-Number Sequencing, and Arithmetic (supplemental). The Processing Speed Index (PSI) includes Coding, Symbol Search, and Cancellation (supplemental). Digit Span: The child repeats numbers in the same or reverse order. Letter-Number Sequencing: The child recalls numbers in ascending and letters in alphabetical order. Symbol Search: The child scans a group to identify target symbols within a time limit. Duration: 10 minutes

To assess working memory as an executive function in adolescents and youth with type 1 diabetes

时间窗: 3 years

Working Memory \& Processing Speed (WAIS) Age Range: 16-90 years The WMI measures working memory, attention, concentration, and reasoning, while the PSI assesses the ability to scan, sequence, and process visual information quickly. Both indices involve cognitive decision-making beyond simple reaction time. Duration: 20 minutes

To assess Shift of set (Wisconsin card sorting test) as an executive function in children and youth with type 1

时间窗: 3 years

Wisconsin Card Sorting Test (WCST-64) Age Range: 6 years 5 months to 89 years The WCST-64 assesses abstract reasoning and executive functions, including cognitive flexibility, goal-directed behavior, planning, and impulse control. Unlike the full WCST, which uses 128 cards, the WCST-64 uses 64 cards. Participants match stimulus cards without explicit instructions, receiving feedback on correctness. The test generates psychometric scores on categories achieved, trials, errors, and perseverative errors. Materials: Four stimulus cards, 64 response cards, and a record form. Duration: 20-30 minutes The WCST has demonstrated reliability and validity across various populations, including individuals with autism, stroke survivors, pediatric groups, and psychiatric patients.

To assess Response inhibition as an executive function in children and youth with type 1 diabetes

时间窗: 3 years

Stroop Test Age Range: Children (5-14 years), Adults (15+ years) The Stroop Test measures response inhibition, assessing the ability to suppress habitual responses in favor of unusual ones. It evaluates cognitive flexibility and prefrontal function. Participants are shown a sheet with color names ("Blue," "Green," "Red") printed in different ink colors. They first read the words column-wise as quickly as possible while the time is recorded. Next, they name the ink color instead of reading the word, with the time again recorded. Score: The Stroop effect score is calculated as: Stroop Effect Score = Time to name colors - Time to read words Uncorrected errors are recorded separately for both phases. Duration: \~20 minutes

To assess Verbal Learning and Memory as cognitive function in children and youth with type 1 diabetes

时间窗: 3 years

Verbal Learning \& Memory: Auditory Verbal Learning Test (AVLT) Age Range: Children (5-15 years), Adults (16-65 years) The AVLT assesses verbal learning and memory using word lists. Adapted by WHO for different cultures, it includes Lists A \& B with 15 familiar words each, translated into Kannada, Tamil, Telugu, and Hindi. Words from List A are presented at a rate of one per second for five trials, with recall recorded after each trial. Then, List B is introduced as an interference task, followed by immediate recall of List A. After 20 minutes, delayed recall of List A is assessed without re-presentation. Finally, a recognition test is conducted by mixing List A words with new words, recording hits and errors. Words are presented in the participant's preferred language (mother tongue or English). Duration: 15 minutes

To assess Test of comprehension as cognitive function in children and youth with type 1 diabetes

时间窗: 3 years

Test of Comprehension: Token Test Age Range: Children (5-15 years), Adults (16-65 years) The Token Test assesses verbal comprehension using tokens that vary in color, size, and shape. Participants follow spoken instructions of increasing complexity. Squares and circles in two sizes and five colors are placed in a fixed arrangement. Instructions are given once per item, with up to two repetitions if needed. Scoring: One point is awarded for correct responses, with a 0.5-point deduction per repetition. A trial is failed if the participant does not follow instructions after two repetitions. The maximum score is 36. Duration: 20 minutes

次要结局

  • To assess mental health in children and youth with type 1 diabetes and their parents(3 years)
  • To assess Diabetes related stress and quality of life in children and youth with type 1 diabetes(3 years)
  • To assess parents' perception towards diabetes related stress and quality of life in their children(3 years)
  • To assess general quality of life in children and youth with type 1 diabetes(3 years)
  • To assess general quality of life in parents of children and youth with type 1 diabetes(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Anuradha Khadilkar

DEPUTY DIRECTOR

Hirabai Cowasji Jehangir Medical Research Institute

研究点 (1)

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