Type2diabetesNCT05939869
Use of AI in Cardiometabolic Risk Prediction in Asian Indians
An observational study of Type2diabetes, run by Diabetes Foundation, India at 1 site in India.
Trial summary
The Investigators are recruiting T2DM patients (n, 500) from Fortis-CDOC Hospital. Patients' weight, BMI, lipid profile, liver and kidney function tests, EGG, glycemic parameters, blood pressure, etc. will be entered in MS Excel sheets and appropriate data coding will be performed. Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2diabetes
- What is being tested?
- Medical and Clinical History
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2023to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Urban Indian Population with minimum duration of 5 years of T2DM.
Who may be able to join
- T2DM
Who cannot join
- T1DM
- Genetic Diabetes
- Gestational Diabetes
- Terminal Illness (Cancer)
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Fortis Cdoc Hospital
New Delhi, National Capital Territory of Delhi, 110048
Anoop Misra, MD, 01149101222, anoopmisra@gmail.com
About this study
Official title: Use of Artificial Intelligence and Machine Learning in Cardiovascular Risk Prediction in Urban Asian Indians
The Investigators are recruiting T2DM patients (n, 500) from Fortis-CDOC Hospital.
Patients' weight, BMI, lipid profile, liver and kidney function tests, EGG, glycemic parameters, blood pressure, etc. will be entered in MS Excel sheets and appropriate data coding will be performed. Additional information on sleep hygiene, self-perceived stress, environmental pollution, and socio-economic status (education, occupation, and family annual income) will be collected by phone interviews. The entered data will be filtered for outliers and missing data will be excluded from the final data sheet.
Read more
Johns Hopkins Team will perform the following:
- Mediation and moderation analysis,
- Machine Learning methods
- Deep Learning and Neural Networks to devise prediction models for different metrics, including diabetes, blood pressure, and lipid control.
- Traditional statistics like Propensity Score Matching and Multivariate Linear Regression
Data pre-processing The data pre-processing will be performed to standardize the variables and minimize the impact of non-normality. During this step, the raw data would be converted into appropriate transformations. Python and R programming will be used for AI and machine learning methods.
Data analysis Our research collaborators are well versed in techniques like multi-fold cross-validation, Synthetic Minority Oversampling Technique for Nominal and Continuous (SMOTE-NC), a widely used technique for balancing the observations only in the training dataset and not in the testing dataset, and hyper tuning of parameters. For our research, we would require a graphic processing unit (GPU) to perform high-quality and fast computing (especially important when analyzing large data sets through neural networks and machine learning). We have an understanding with ORACLE (a large software giant), for providing GPUs at no cost on a lease basis on the submission of a feasible proposal.
Key Milestones Expected
- During the initial three months of the study, the plan is to obtain all requisite permissions for data gathering from the Institutional Ethics Review Committees of the respective institutions. The research assistant would be recruited from FORTIS-CDOC Hospital.
- Over the next 12 months, there will be data tabulation and gathering
- The last 3-4 months will be allocated to data analysis, application of AI algorithms (using training and testing datasets), and reporting of the data (meetings and manuscripts)
Read the detailed description
AI is a term that encapsulates machine learning (ML), deep learning, supervised learning, unsupervised learning, artificial neural networks (ANNs), and convolutional neural networks (CNNs). An essential component of AI, ML, is being increasingly used in health care applications, since it is an interdisciplinary field which uses techniques to enable computers to examine data sets without explicit programming. ML involves development of a model or algorithm by careful extraction of essential features from the training data which is used for testing purpose. Test data is utilized for making predictions about research problems. ML can be effectively summarized as: feature extraction, selection of technique for data analysis, training of the new model and evaluation of its efficacy, and making predictions using the trained model. Supervised and unsupervised learning are forms of machine learning. In supervised learning, known data sets are used to understand the patterns in data sets, whereas in unsupervised learning, unlabeled data sets are used to understand the data.
Deep learning structures use numerous layers of computation. DL is mainly used for processing large and raw data sets. In ANN, multiple machine learning algorithms work together and process data inputs, but in CNN, hidden nodes exist in layers for information, complex data, and image processing. With rapid advancement in AI, ML, and DL, computer programs can effectively simulate neural activity of the brain's neocortex where reasoning, thinking, and cognitive functions take place at a fast pace.
In the domain of cardiovascular medicine, AI has extensive applications in drug therapy, pharmacogenomics, heart failure, imaging studies, and diagnostics. Importantly, AI has the ability to provide mechanisms to apply precision medicine and big data in medicine while enhancing the effectiveness of treatment regimen advised by the cardiologist. Further, AI/ML algorithms can analyze data without assumptions for prediction and classification purposes. Thus, cardiovascular medicine can benefit remarkably from the incorporation and judicious utilization of AI.
Cardiometabolic disorders (CMDs) including myocardial infarction, stroke, and type 2 diabetes mellitus (T2DM), are linked with an increased morbidity and mortality, and it is known that an individual's lifestyle and level of exercise are significant risk factors for CVD. This is especially true for patients who spend considerable periods of time doing sedentary work, have limited mobility, or find it challenging to sustain acceptable amounts of exercise, let alone reach the moderate-to-vigorous levels advised for cardiometabolic health.
Asian Indians are one of the largest growing ethnic groups in the world and have one of the highest rates of cardiovascular disease (CVD), including T2DM coronary artery disease (including major adverse cardiovascular events or MACE). Several causes of CVD have been identified, such as adoption of western dietary patterns and habits, genetic predisposition, imbalance in lipoproteins, and abdominal obesity. Certain perinatal influences are also regarded as possible contributors.
High consumption of omega-6 PUFAs and saturated fat are significantly correlated with fasting hyperinsulinemia and sub-clinical inflammation. Such imbalanced diets contribute to high prevalence of insulin resistance, the metabolic syndrome and T2DM in Asian Indians. Further, genetic, cultural, and socio-economic factors have also resulted in this healthcare crisis. Studies have consistently shown that Asian Indians have a high prevalence of insulin resistance which increases their tendency to develop T2DM and CVD at a younger age as compared to individuals of other ethnicities. Important reasons could be their excess body fat and adverse body fat patterning, including abdominal adiposity, even when the body mass index is within the currently defined normal limits. Some of these features have been reported at birth and childhood.
The American Diabetes Association (ADA) has lowered the BMI cut-off (compared to Caucasians) for T2DM screening in South Asians. Some of the problems encountered are: variability in clinical risk stratification; lack of established guidelines for atherosclerosis imaging, and scarcity of data for formulation of meaningful clinical guidelines in persons of Asian Indian ethnicity.
The population of Asian Indian is increasing in the United States at a rapid pace. A recent research study by the American Heart Association (AHA) underscores the increasing prevalence and mortality associated with CVD in this ethnicity, contributed mainly by insulin resistance and increased incidence of T2DM. Indians are representative of a highly successful group of immigrants with higher incomes and better social and economic indicators. The preliminary data obtained from this AI based study will enable our team in obtaining the necessary funds for long-term prospective research in this field.
- Conditions
- Type2diabetes
- Being tested
- Medical and Clinical History
- Keywords
- Type 2 Diabetes, Asian Indian, CVD
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical and Clinical HistoryOther
Retrospective and prospective analysis of patients data will be done.
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of CVD Event
How many T2DM patients will get MI or Stroke within next five years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- National Diabetes Obesity and Cholesterol Foundation, Johns Hopkins University
- Responsible party
- Principal investigator, Dr Anoop Misra, Diabetes Foundation, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939869
- Sponsor's protocol ID
- AI
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Artificial Intelligence and Machine Learning in Cardiovascular Risk Prediction in Urban Asian Indians
- ClinicalTrials.gov ID
- NCT05939869
- Acronym / sponsor ID
- AI
- Conditions
- Type2diabetes
- Keywords
- Type 2 Diabetes, Asian Indian, CVD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Collaborators
- National Diabetes Obesity and Cholesterol Foundation, Johns Hopkins University
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Investigators are recruiting T2DM patients (n, 500) from Fortis-CDOC Hospital.
Patients' weight, BMI, lipid profile, liver and kidney function tests, EGG, glycemic parameters, blood pressure, etc. will be entered in MS Excel sheets and appropriate data coding will be performed. Additional information on sleep hygiene, self-perceived stress, environmental pollution, and socio-economic status (education, occupation, and family annual income) will be collected by phone interviews. The entered data will be filtered for outliers and missing data will be excluded from the final data sheet.
Johns Hopkins Team will perform the following:
- Mediation and moderation analysis,
- Machine Learning methods
- Deep Learning and Neural Networks to devise prediction models for different metrics, including diabetes, blood pressure, and lipid control.
- Traditional statistics like Propensity Score Matching and Multivariate Linear Regression
Data pre-processing The data pre-processing will be performed to standardize the variables and minimize the impact of non-normality. During this step, the raw data would be converted into appropriate transformations. Python and R programming will be used for AI and machine learning methods.
Data analysis Our research collaborators are well versed in techniques like multi-fold cross-validation, Synthetic Minority Oversampling Technique for Nominal and Continuous (SMOTE-NC), a widely used technique for balancing the observations only in the training dataset and not in the testing dataset, and hyper tuning of parameters. For our research, we would require a graphic processing unit (GPU) to perform high-quality and fast computing (especially important when analyzing large data sets through neural networks and machine learning). We have an understanding with ORACLE (a large software giant), for providing GPUs at no cost on a lease basis on the submission of a feasible proposal.
Key Milestones Expected
- During the initial three months of the study, the plan is to obtain all requisite permissions for data gathering from the Institutional Ethics Review Committees of the respective institutions. The research assistant would be recruited from FORTIS-CDOC Hospital.
- Over the next 12 months, there will be data tabulation and gathering
- The last 3-4 months will be allocated to data analysis, application of AI algorithms (using training and testing datasets), and reporting of the data (meetings and manuscripts)
Detailed description
AI is a term that encapsulates machine learning (ML), deep learning, supervised learning, unsupervised learning, artificial neural networks (ANNs), and convolutional neural networks (CNNs). An essential component of AI, ML, is being increasingly used in health care applications, since it is an interdisciplinary field which uses techniques to enable computers to examine data sets without explicit programming. ML involves development of a model or algorithm by careful extraction of essential features from the training data which is used for testing purpose. Test data is utilized for making predictions about research problems. ML can be effectively summarized as: feature extraction, selection of technique for data analysis, training of the new model and evaluation of its efficacy, and making predictions using the trained model. Supervised and unsupervised learning are forms of machine learning. In supervised learning, known data sets are used to understand the patterns in data sets, whereas in unsupervised learning, unlabeled data sets are used to understand the data.
Deep learning structures use numerous layers of computation. DL is mainly used for processing large and raw data sets. In ANN, multiple machine learning algorithms work together and process data inputs, but in CNN, hidden nodes exist in layers for information, complex data, and image processing. With rapid advancement in AI, ML, and DL, computer programs can effectively simulate neural activity of the brain's neocortex where reasoning, thinking, and cognitive functions take place at a fast pace.
In the domain of cardiovascular medicine, AI has extensive applications in drug therapy, pharmacogenomics, heart failure, imaging studies, and diagnostics. Importantly, AI has the ability to provide mechanisms to apply precision medicine and big data in medicine while enhancing the effectiveness of treatment regimen advised by the cardiologist. Further, AI/ML algorithms can analyze data without assumptions for prediction and classification purposes. Thus, cardiovascular medicine can benefit remarkably from the incorporation and judicious utilization of AI.
Cardiometabolic disorders (CMDs) including myocardial infarction, stroke, and type 2 diabetes mellitus (T2DM), are linked with an increased morbidity and mortality, and it is known that an individual's lifestyle and level of exercise are significant risk factors for CVD. This is especially true for patients who spend considerable periods of time doing sedentary work, have limited mobility, or find it challenging to sustain acceptable amounts of exercise, let alone reach the moderate-to-vigorous levels advised for cardiometabolic health.
Asian Indians are one of the largest growing ethnic groups in the world and have one of the highest rates of cardiovascular disease (CVD), including T2DM coronary artery disease (including major adverse cardiovascular events or MACE). Several causes of CVD have been identified, such as adoption of western dietary patterns and habits, genetic predisposition, imbalance in lipoproteins, and abdominal obesity. Certain perinatal influences are also regarded as possible contributors.
High consumption of omega-6 PUFAs and saturated fat are significantly correlated with fasting hyperinsulinemia and sub-clinical inflammation. Such imbalanced diets contribute to high prevalence of insulin resistance, the metabolic syndrome and T2DM in Asian Indians. Further, genetic, cultural, and socio-economic factors have also resulted in this healthcare crisis. Studies have consistently shown that Asian Indians have a high prevalence of insulin resistance which increases their tendency to develop T2DM and CVD at a younger age as compared to individuals of other ethnicities. Important reasons could be their excess body fat and adverse body fat patterning, including abdominal adiposity, even when the body mass index is within the currently defined normal limits. Some of these features have been reported at birth and childhood.
The American Diabetes Association (ADA) has lowered the BMI cut-off (compared to Caucasians) for T2DM screening in South Asians. Some of the problems encountered are: variability in clinical risk stratification; lack of established guidelines for atherosclerosis imaging, and scarcity of data for formulation of meaningful clinical guidelines in persons of Asian Indian ethnicity.
The population of Asian Indian is increasing in the United States at a rapid pace. A recent research study by the American Heart Association (AHA) underscores the increasing prevalence and mortality associated with CVD in this ethnicity, contributed mainly by insulin resistance and increased incidence of T2DM. Indians are representative of a highly successful group of immigrants with higher incomes and better social and economic indicators. The preliminary data obtained from this AI based study will enable our team in obtaining the necessary funds for long-term prospective research in this field.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Urban Indian Population with minimum duration of 5 years of T2DM.
Key inclusion criteria (1 listed)
- T2DM
Key exclusion criteria (4 listed)
- T1DM
- Genetic Diabetes
- Gestational Diabetes
- Terminal Illness (Cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical and Clinical HistoryRetrospective and prospective analysis of patients data will be done. | Other | – |
Primary outcome
Risk of CVD Event
Time frame: 5 years
How many T2DM patients will get MI or Stroke within next five years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2diabetes, run by Diabetes Foundation, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANOOP MISRA, MD (01149101222, anoopmisra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of CVD Event (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.