Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-29 @ 2:25 AM
Study NCT ID:
NCT07164768
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-10
First Post:
2024-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Function and Mental Health in Children and Youth With Type 1 Diabetes (T1D)
Sponsor:
Hirabai Cowasji Jehangir Medical Research Institute
Organization:
Study Overview
Official Title:
Cognitive Function and Mental Health in Children and Youth With Type 1 Diabetes (T1D) and Its Determinants
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DMBCOG
Brief 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.
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.
Detailed Description:
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.
Sample size estimations:
The investigator expects to recruit one in two of participant with type 1 diabetes from our cohort and age gender matched healthy controls without type 1 diabetes. Sample size estimation suggests a sample size of 396 participants (264 cases and 132 controls) would be adequately powered to detect group differences with moderate effect size.
Procedure:
Institutional ethics committee approval will be obtained for the study. Children with T1D will be approached for participation and information about the study will be provided. T1D children and their parents will be recruited after obtaining informed parental consent from children less than 12 years and parent consent and child's assent for those above 12 years of age. Informed consent will be obtained from those above 18 years of age.
Exposures:
Systematic assessments of the exposures (Type 1 diabetes, Birth weight, parental education, occupation, mental health, parenting style) will be performed in the cohort. This data of recruited subjects will be extracted from available records as well as collecting their current information using a standardized questionnaire.
Glucose values and HbA1c measured in the clinic at the time of neurocognitive testing will be taken to study the associations between the glycemic control in T1D children and their neurocognitive outcomes.
Additionally, Brain Derived Neurotrophic Factor (BDNF) which is a key molecule involved in neuroplastic changes related to learning and memory will also be measured.
Outcomes:
Cognitive function and mental health of children, adolescents and young adults with T1D Following measurements will be performed in T1D children based on their age at assessment.
1. Neurocognitive measurements: Global measures of intelligence was assessed using the Raven's progressive Matrices.
2. Mental health in children and parents: Depression, anxiety and stress related information will be collected using specific questionnaires.
3. Quality of life in children and parents using Peds QL standardised modules and questionnaires.
Cognitive function assessments (general intellectual test, IQ):
1. Raven's Colored Progressive Matrices: Raven's Progressive Matrices (often referred to simply as Raven's Matrices) or RPM is a non-verbal test typically used to measure general human intelligence and abstract reasoning and is regarded as a non-verbal estimate of fluid intelligence.
2. Speed: Finger tapping: It is the measure of motor speed. Age range: 9 years and above The finger-tapping test consists of an especially adopted electric finger-tapping instrument and monitor to read the number of taps.
3. Attention: d2: It is a refinement of the cancellation test. Age range 9-60 years.
4. Executive functioning:
* Verbal fluency: FAS test. Age range: Children: 5 to 15 years
* Animal names test: Age range: Children: 5 to 15 years
* COWA test (Controlled Oral Word Association test). Adults: 15 to 65 years
* Working memory: Digit and letter number (WISC). Age range: 6 to 16 years.
* Processing speed: Coding and symbol search (WISC). Age range: 6 to 16 years.
* Working memory: Digit and arithmetic (WAIS) \[8\] and Coding and symbol search (WAIS). Age range: 16 to 90 years
* Working Memory Index- subtests include Digit span and arithmetic. Processing Speed Index- subtests include symbol search, coding, and cancellation.
* Shift of set (Wisconsin card sorting test 64: Age range: 6 years 5 months to 89 years
* Response inhibition: Stroop test. Age range: Children: 5-14 years, Adults: 15 years and above
5. Verbal learning and memory: Auditory verbal learning test (AVLT): Age range: Children: 5 to 15 years, Adults: 16 to 65 years
6. Test of comprehension: Token test: Age range: Children: 5 to 15 years, Adults: 16 to 65 years
Mental health and quality of life in children and parents:
1. CBCL (The Child Behavior Checklist): The 2001 revision of the CBCL, the CBCL/6-18 (used with children 6 to 18), is made up of eight syndrome scales:
* anxious/depressed
* depressed
* somatic complaints
* social problems
* thought problems
* attention problems
* rule-breaking behaviour
* aggressive behaviour
2. BSI (Brief Symptom Inventory): The Brief Symptom Inventory (BSI) consists of 53 items covering nine symptom dimensions: Somatization, Obsession-Compulsion, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation and Psychoticism; and three global indices of distress: Global Severity Index, Positive Symptom Distress Index, and Positive Symptom Total. The global indices measure current or past level of symptomatology, intensity of symptoms, and number of reported symptoms, respectively.
3. Quality of life:
Peds QL: The Pediatric Quality of Life Inventory (PedsQL): PedsQL Generic Core Scale will be used to measure generic health-related quality of life of the children, adolescents and young adults in this study. This scale is applicable for healthy school and community populations, as well as patient populations with acute and chronic health conditions.
Effect modifiers:
1. Parents' mental health: This will be assessed using BSI questionnaire.
2. Parenting style: The Parenting Styles and Dimensions Questionnaire (PSDQ)\[19\] is one measure that is widely utilized in current research to examine parenting styles.
3. Parents' quality of life: PedsQL Generic Core Scale will be used to measure generic health-related quality of life of the primary caregiver (any one parent, either mother or father).
4. Parental education and occupation: This information will be collected using standard questionnaires for general information.
5. Scholastic performance: Academic exposure can positively impact cognitive functioning. This will be assessed by taking the average marks/grades obtained by the child in previous year academic performance.
Mediators:
1. Glycemic control and complications of type 1 diabetes:
The investigators regularly perform the annual checkups in our type 1 cohort. In that following measurements are performed to assess their glycemic control and development of micro and macrovascular complications.
2. Human BDNF (Brain Derived Neurotrophic Factor): This will be measured using standard enzymatic method using Elabscience® Human BDNF (Brain Derived Neurotrophic Factor) ELISA Kit. Association between BDNF levels and cognitive functions will be studied.
3. Growth and development: This data will be utilized from the anthropometric measurements performed at the time of their annual check-ups. Pubertal staging is performed by a pediatric endocrinologist or a medical officer. Information regarding age and date of menarche is also collected.
4. Lifestyle (nutrition and physical activity): The investigators also collect the information regarding their nutritional intake using a 24-hour dietary recall and data regarding their physical activity levels using standard questionnaire. Using this data, the investigators can study the association between lifestyle with cognitive functions
Measurement of potential confounders:
1. A semistructured proforma will be designed to collect socio-demographic information, current educational status, Parental education. Socio-economic status will be assessed using the Kuppuswamy 2023 coding and scale.
2. Family history of neurodevelopmental/neurological/mental health disorders will be obtained on a three generation genogram.
3. Pubertal status will be assessed on the Tanner's staging for Puberty by medical officer.
Future implications:
Early detection and intervention for cognitive impairment in the early stages of Type 1 Diabetes Mellitus (T1DM) can facilitate effective treatment. Cognitive impairment is closely linked to poor glycaemic control and associated metabolic disruptions in T1DM. Initiating the management of metabolic abnormalities during the initial phases of diabetes holds the potential to prevent cognitive impairment. It is essential to include cognitive impairment screening for individuals with T1DM alongside assessments for other recognised macro- and microvascular complications of diabetes.
In addition to evaluating children with T1D, conducting assessments for their parents, including an analysis of parenting styles and stress levels associated with managing their child's diabetes, allows for the strategic planning of interventions.
This holistic approach not only enhances parents' diabetes management but also contributes to improved glycaemic control in T1D children, thereby positively influencing their cognitive function.
Detecting and addressing cognitive impairment at an early stage not only aids in the effective management of diabetes in children but also plays a pivotal role in fostering improved career prospects and job opportunities for them. Additionally, this proactive approach contributes to an overall enhancement of their quality of life. The downstream effect of these positive outcomes includes a reduction in the health-related and economic burden faced by India.
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.
Sample size estimations:
The investigator expects to recruit one in two of participant with type 1 diabetes from our cohort and age gender matched healthy controls without type 1 diabetes. Sample size estimation suggests a sample size of 396 participants (264 cases and 132 controls) would be adequately powered to detect group differences with moderate effect size.
Procedure:
Institutional ethics committee approval will be obtained for the study. Children with T1D will be approached for participation and information about the study will be provided. T1D children and their parents will be recruited after obtaining informed parental consent from children less than 12 years and parent consent and child's assent for those above 12 years of age. Informed consent will be obtained from those above 18 years of age.
Exposures:
Systematic assessments of the exposures (Type 1 diabetes, Birth weight, parental education, occupation, mental health, parenting style) will be performed in the cohort. This data of recruited subjects will be extracted from available records as well as collecting their current information using a standardized questionnaire.
Glucose values and HbA1c measured in the clinic at the time of neurocognitive testing will be taken to study the associations between the glycemic control in T1D children and their neurocognitive outcomes.
Additionally, Brain Derived Neurotrophic Factor (BDNF) which is a key molecule involved in neuroplastic changes related to learning and memory will also be measured.
Outcomes:
Cognitive function and mental health of children, adolescents and young adults with T1D Following measurements will be performed in T1D children based on their age at assessment.
1. Neurocognitive measurements: Global measures of intelligence was assessed using the Raven's progressive Matrices.
2. Mental health in children and parents: Depression, anxiety and stress related information will be collected using specific questionnaires.
3. Quality of life in children and parents using Peds QL standardised modules and questionnaires.
Cognitive function assessments (general intellectual test, IQ):
1. Raven's Colored Progressive Matrices: Raven's Progressive Matrices (often referred to simply as Raven's Matrices) or RPM is a non-verbal test typically used to measure general human intelligence and abstract reasoning and is regarded as a non-verbal estimate of fluid intelligence.
2. Speed: Finger tapping: It is the measure of motor speed. Age range: 9 years and above The finger-tapping test consists of an especially adopted electric finger-tapping instrument and monitor to read the number of taps.
3. Attention: d2: It is a refinement of the cancellation test. Age range 9-60 years.
4. Executive functioning:
* Verbal fluency: FAS test. Age range: Children: 5 to 15 years
* Animal names test: Age range: Children: 5 to 15 years
* COWA test (Controlled Oral Word Association test). Adults: 15 to 65 years
* Working memory: Digit and letter number (WISC). Age range: 6 to 16 years.
* Processing speed: Coding and symbol search (WISC). Age range: 6 to 16 years.
* Working memory: Digit and arithmetic (WAIS) \[8\] and Coding and symbol search (WAIS). Age range: 16 to 90 years
* Working Memory Index- subtests include Digit span and arithmetic. Processing Speed Index- subtests include symbol search, coding, and cancellation.
* Shift of set (Wisconsin card sorting test 64: Age range: 6 years 5 months to 89 years
* Response inhibition: Stroop test. Age range: Children: 5-14 years, Adults: 15 years and above
5. Verbal learning and memory: Auditory verbal learning test (AVLT): Age range: Children: 5 to 15 years, Adults: 16 to 65 years
6. Test of comprehension: Token test: Age range: Children: 5 to 15 years, Adults: 16 to 65 years
Mental health and quality of life in children and parents:
1. CBCL (The Child Behavior Checklist): The 2001 revision of the CBCL, the CBCL/6-18 (used with children 6 to 18), is made up of eight syndrome scales:
* anxious/depressed
* depressed
* somatic complaints
* social problems
* thought problems
* attention problems
* rule-breaking behaviour
* aggressive behaviour
2. BSI (Brief Symptom Inventory): The Brief Symptom Inventory (BSI) consists of 53 items covering nine symptom dimensions: Somatization, Obsession-Compulsion, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation and Psychoticism; and three global indices of distress: Global Severity Index, Positive Symptom Distress Index, and Positive Symptom Total. The global indices measure current or past level of symptomatology, intensity of symptoms, and number of reported symptoms, respectively.
3. Quality of life:
Peds QL: The Pediatric Quality of Life Inventory (PedsQL): PedsQL Generic Core Scale will be used to measure generic health-related quality of life of the children, adolescents and young adults in this study. This scale is applicable for healthy school and community populations, as well as patient populations with acute and chronic health conditions.
Effect modifiers:
1. Parents' mental health: This will be assessed using BSI questionnaire.
2. Parenting style: The Parenting Styles and Dimensions Questionnaire (PSDQ)\[19\] is one measure that is widely utilized in current research to examine parenting styles.
3. Parents' quality of life: PedsQL Generic Core Scale will be used to measure generic health-related quality of life of the primary caregiver (any one parent, either mother or father).
4. Parental education and occupation: This information will be collected using standard questionnaires for general information.
5. Scholastic performance: Academic exposure can positively impact cognitive functioning. This will be assessed by taking the average marks/grades obtained by the child in previous year academic performance.
Mediators:
1. Glycemic control and complications of type 1 diabetes:
The investigators regularly perform the annual checkups in our type 1 cohort. In that following measurements are performed to assess their glycemic control and development of micro and macrovascular complications.
2. Human BDNF (Brain Derived Neurotrophic Factor): This will be measured using standard enzymatic method using Elabscience® Human BDNF (Brain Derived Neurotrophic Factor) ELISA Kit. Association between BDNF levels and cognitive functions will be studied.
3. Growth and development: This data will be utilized from the anthropometric measurements performed at the time of their annual check-ups. Pubertal staging is performed by a pediatric endocrinologist or a medical officer. Information regarding age and date of menarche is also collected.
4. Lifestyle (nutrition and physical activity): The investigators also collect the information regarding their nutritional intake using a 24-hour dietary recall and data regarding their physical activity levels using standard questionnaire. Using this data, the investigators can study the association between lifestyle with cognitive functions
Measurement of potential confounders:
1. A semistructured proforma will be designed to collect socio-demographic information, current educational status, Parental education. Socio-economic status will be assessed using the Kuppuswamy 2023 coding and scale.
2. Family history of neurodevelopmental/neurological/mental health disorders will be obtained on a three generation genogram.
3. Pubertal status will be assessed on the Tanner's staging for Puberty by medical officer.
Future implications:
Early detection and intervention for cognitive impairment in the early stages of Type 1 Diabetes Mellitus (T1DM) can facilitate effective treatment. Cognitive impairment is closely linked to poor glycaemic control and associated metabolic disruptions in T1DM. Initiating the management of metabolic abnormalities during the initial phases of diabetes holds the potential to prevent cognitive impairment. It is essential to include cognitive impairment screening for individuals with T1DM alongside assessments for other recognised macro- and microvascular complications of diabetes.
In addition to evaluating children with T1D, conducting assessments for their parents, including an analysis of parenting styles and stress levels associated with managing their child's diabetes, allows for the strategic planning of interventions.
This holistic approach not only enhances parents' diabetes management but also contributes to improved glycaemic control in T1D children, thereby positively influencing their cognitive function.
Detecting and addressing cognitive impairment at an early stage not only aids in the effective management of diabetes in children but also plays a pivotal role in fostering improved career prospects and job opportunities for them. Additionally, this proactive approach contributes to an overall enhancement of their quality of life. The downstream effect of these positive outcomes includes a reduction in the health-related and economic burden faced by India.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: