Clinical trial NCT06693934: Jockey Club Precision Prevention Programme on Young Onset Diabetes
Official title: Jockey Club Precision Prevention Programme on Young Onset Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Pre Diabetes
Hypertension
Dyslipidemia
Obesity
Keywords: Diabetes
Pre Diabetes
YOD
DM
Young Onset diabetes
Genetic test
Management
Prevention
Hypertension
Dyslipidemia
Obesity
Lead sponsor: Asia Diabetes Foundation
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
name: St. James' Settlement
name: Asia Diabetes Foundation
First posted: 2024-11-19
Enrollment: 9000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a community-based implementation program consisting of multiple components delivered by a multidisciplinary team to detect and prevent young onset diabetes with precision and value using biogenetic markers, digital tools, integrated care through public private partnership. Adults aged between 18 and 44 (inclusive) without known diabetes and with at least one risk factor for diabetes will undergo a saliva DNA and capillary blood test and complete a questionnaire. Depending on their risk levels, participants will be stratified to high risk and low risk progressors to diabetes. The high risk progressors will undergo annual oral glucose tolerance test to detect diabetes and impaired glucose tolerance (IGT). All participants will receive a personalized report indicating their genetic and modifiable risk explained by nurses or doctors. All participants will be offered regular access to webinars for education and empowerment for 2 years. The high risk group will additionally receive a 2-year risk-stratified intervention with different combinations of care interventions. These include clinical and laboratory assessment for comprehensive evaluation of cardiovascular-kidney-metabolic risks, medical and nurse consultations, empowerment by health messages, webinars, face-to-face workshops, subsidies for medications and self-monitoring tools (e.g. CGM devices, weighing scale) to motivate behavioural change. The outcomes will be analysed within the REAIM framework (reach, effectiveness, adoption, implementation and maintenance), progresssion to prediabetes or diabetes, patient reported outcomes and cost effectiveness.

Detailed description: BACKGROUND AND RATIONALE:

In Hong Kong, 1 in 10 adults have diabetes. In hospital-based clinic setting, 1 in 5 adults with diabetes were diagnosed before the age of 40, i.e. young-onset diabetes (YOD). The latter is the major driver of recurrent hospitalizations, critical illnesses and premature death. Compared to fasting plasma glucose (FPG) or HbA1c, 2-hour PG is needed to detect impaired glucose tolerance (IGT) and diabetes (DM). Besides, 2-h PG is more robust than FPG or HbA1c in predicting major events and death. The selection of participants with IGT for intervention is based on the positive effects of lifestyle modification and metformin only in individuals with IGT and not in individuals with isolated IFG in randomized clinical trials. Besides, there is strong familial tendency of YOD and based on our published and in-house 20-year prospective data in a workforce, 80% of people who developed DM came from 20-30% of individuals with high genetic risk unmasked by modifiable risk factors such as obesity and smoking.

In this implementation project, investigators shall use a 2-stepped approach to identify adults aged between 18 and 44 (inclusive) with genetic predisposition to undergo yearly OGTT to diagnose IGT and diabetes early for intervention. Investigators shall apply the proprietary DForesee (DF) risk algorithm including clinical and biogenetic risk factors to select the top 25% of participants at the highest risk for IGT or diabetes in next 10 years to undergo yearly OGTT accompanied by a risk-based intervention program.

STUDY DESIGN AND METHODS:

By using quasi-experimental design based on an evidence-based multi-component strategy, investigators aim to detect and delay the onset of diabetes in adults aged less than 45 years. Investigators aim to identify 9,000 adults aged between 18 and 44 years (inclusive) in community- and clinic settings during a 2-year period, followed by 2 years of risk-stratified intervention. Investigators shall use clinical and biogenetic assessment including DNA testing, capillary blood test and administration of questionnaires to classify participants to high risk and low risk progressors. All participants will receive risk-based intervention. Low risk progressors will receive a personalized report indicating their genetic and modifiable risk explained by nurses and with repeated clinical and biogenetic assessment at year 2. The high risk progressors will additionally undergo annual oral glucose tolerance test to detect diabetes and impaired glucose tolerance (IGT) and will receive a personalized report explained by doctors. All participants will be offered regular access to webinars for education and empowerment for 2 years. The high risk group will additionally receive a 2-year risk-stratified intervention with different combinations of care interventions. These include clinical and laboratory assessment for comprehensive evaluation of cardiovascular-kidney-metabolic risks, medical and nurse consultations, empowerment by health messages, webinars, face-to-face workshops, subsidies for medications and self-monitoring tools (e.g. CGM devices for IGT and DM groups only, weighing scale for all high risk progressors) to motivate behavioural change.

INCLUSION and EXCLUSION CRITERIA Age 18-44 (inclusive) years without known diabetes, at least one risk factor for diabetes and with usual place of residence in Hong Kong, The risk factors for diabetes include central or general obesity, family history of diabetes, smoking history, history of hypertension, high blood glucose level, abnormal lipid level/ vascular disease, or fatty liver, history of gestational diabetes polycystic ovary syndrome or delivery of baby≥ 4kg (for women only), less than 150mins of physical activity every week.

People with known diabetes or conditions considered to be unsuitable by the project team including illiteracy will be excluded.

OUTCOME MEASURES The outcomes will be analysed within the REAIM framework (reach, effectiveness, adoption, implementation and maintenance), progresssion to prediabetes or diabetes, patient reported outcomes and cost effectiveness.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 44 years old
* With at least one risk factor for diabetes

Exclusion Criteria:

* Known history of Diabetes
* With conditions considered not suitable by the project team (including illiteracy)

The risk factors for diabetes include central or general obesity, family history of diabetes, smoking history, history of hypertension/ high blood glucose level/ abnormal lipid level/ vascular disease/ fatty liver, history of gestational diabetes/ polycystic ovary syndrome/ delivery of baby≥ 4kg (for women only), and less than 150mins of physical activity every week.

Primary outcomes:
measure: Incidence of prediabetes or diabetes in the high and low risk progressor groups
timeFrame: From the date of recruitment until the end of the programme in 2 years.
Secondary outcomes:
measure: The conversion rate of glycaemic status including Impaired fasting glucose (IFG), Impaired glucose tolerance (IGT) and diabetes over the study period
timeFrame: From the date of recruitment until the end of the programme in 2 years.
measure: Change in the HbA1c over the study period
timeFrame: From the date of recruitment until the end of the Programme in 2 years
measure: Change in the blood glucose level including FPG and 2-hour PG over the study period
timeFrame: From the date of recruitment until the end of the Programme in 2 years
measure: Change in the blood pressure level over the study period
timeFrame: From the date of the recruitment until the end of the Programme in 2 years
measure: Change in lipids level including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides over study period
timeFrame: From the date of recruitment until the end of the programme in 2 years
measure: Change in body weight over the study period
timeFrame: From the date of the recruitment until the end of the programme in 2 years
measure: Change in waist circumference over the study period
timeFrame: From the date of the recruitment until the end of the Programme in 2 years
measure: Change in albuminuria over the study period
timeFrame: From the date of the recruitment until the end of the programme in 2 years
measure: Change in health literacy over the study period by using questionnaire
timeFrame: From the date of recruitment until the end of the programme in 2 years
measure: Quality of life using EuroQoL with 5 demensions and 3 levels (EQ-5D-3L) Questionnaire
timeFrame: From the date of recruitment until the end of the programme in 2 years
measure: Change in lifestyles including eating habits, exercises, sleeping habits, smoking and alcohol over the study period by using questionnaire
timeFrame: From the date of recruitment until the end of the programme in 2 years
measure: The number of usage in healthcare resources such as clinic visits and hospital admissions
timeFrame: From the date of recruitment until the end of the programme in 2 years
measure: Cost-effectiveness analysis by mearsuring the transition rate of progression from normal glucose tolerace to IGT and IGT to diabetes during 4 year programme
timeFrame: From the date of recruitment until the end of the programme in 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Asia Diabetes Foundation
Study officials:
affiliation: Chinese University of Hong Kong
name: Juliana CN Chan
role: PRINCIPAL_INVESTIGATOR
References: