Type 2 DiabetesNCT04049149
Precision Medicine in Chinese Patients With Young Onset Diabetes
A study testing Biogenetic explanation and endocrinologist intensive managment in people with Type 2 Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Patients with young onset diabetes (YOD) are one of the most challenging groups of patients due to their long disease duration, complex causes, delayed interventions, psychosocial stress, poor adherence and frequent default. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Biogenetic explanation and endocrinologist intensive managment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 884 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Jan 2020to 31 Dec 2024
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Part 1: Prospective cohort of Chinese with type 2 diabetes
- Between 1995 and December 2004, 10,129 patients were assessed using structured protocol to esetablish the HKDR and of them, we have measured GADA and CP in 1400 patients with YOD. In this study, we shall measure CP and GADA in 4000 subjects from the HKDR with available GWAS data irrespective of their age of diagnosis. These samples were linked to our various databases by a unique identification code which will enable us to track the clinical outcomes including development of complications.
- Part 2: Family-based cohort of first-degree relatives of diabetic probands
- We shall utilize the resource of the HKDFS and control subjects to discover novel genetic variants of YOD. Subjects will be selected based on their status with or without diabetes. In 2012-2013, we ascertained the glycemic status of 365 siblings in the HKDFS and 452 participants of the community-based LKS cohort (aged 18-55 years) without diabetes at baseline (1998-2002).
- In this cohort, 167 participants (53.7%) with a family history of YOD, 68 participants (30.1%) with a family history of late onset diabetes and 40 (14.4%) participants without family history of diabetes developed diabetes. Amongst the 313 siblings with family history of YOD, 167 had diabetes at baseline or developed diabetes during follow up and 146 did not develop diabetes after 13 years giving 100-120 sibpairs for linkage analysis. These sequence data will be imputed with 500 YOD patients and 500 control subjects with exome data as well as 6000 patients in the HKDR with GWAS data for analysis for validation purpose.
- Part 3: RCT (PRISM)
Show all 11Show fewer
- Non-type 1 diabetes (T1D)
- Chinese ethnicity
- Age between 18-50 years inclusive
- Age at diabetes diagnosis 40 years
- Able to understand study requirements and voluntarily agree to participate by providing written informed consent
Who cannot join
- Part 1/2:
- Subjects in the HKDR, HKFDS and LKS cohorts without or insuffiicent amount of biosamples for assays or sequencing.
- Part 3:
- T1D, defined by presentation with diabetic ketoacidosis or insulin requirement within 6 months of diagnosis.
- Reduced life expectancy due to terminal illness or otherwise deemed not appropriate per discretion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Precision Medicine to Redefine Insulin Secretion and Monogenic Diabetes (PRISM) in Chinese Patients With Young Onset Diabetes
Patients with young onset diabetes (YOD) are one of the most challenging groups of patients due to their long disease duration, complex causes, delayed interventions, psychosocial stress, poor adherence and frequent default. The investigator's previous studies indicate that provision of biogenetic information improved satisfaction, reduced ambiguity and improved self-efficacy in patients with T2D. Provision of personalized information using the web-based Joint Asia Diabetes Evaluation (JADE) Technology with risk stratification and decision support empowers better self care and medical intervention with improved control of risk factors. To further improve the precision of diagnosis for individualizing care, the use of CP, GADA, genetic risk scores (GRS) or rare genetic variants of maturity onset of diabetes (MODY) can help doctors select the most appropriate therapy in a timely manner. While patients with low CP, GADA and high GRS will benefit from early insulin therapy, some MODY variants are associated with good response to insulin-releasing oral drugs (e.g. sulphonylurea) which may spare the use of insulin with reduced patient distress and over-insulinization. By contrast, patients with high CP often due to obesity-associated insulin resistance should undergo intensive lifestyle modification and use of drugs with weight-reducing or neutral effects to avoid weight gain due to excessive dose of insulin.
Read the detailed description
Patients with young onset diabetes (YOD) are one of the most challenging groups of patients due to their long disease duration, complex causes, delayed interventions, psychosocial stress, poor adherence and frequent default. The investigator's previous studies indicate that provision of biogenetic information improved satisfaction, reduced ambiguity and improved self-efficacy in patients with T2D. Provision of personalized information using the web-based Joint Asia Diabetes Evaluation (JADE) Technology with risk stratification and decision support empowers better self care and medical intervention with improved control of risk factors. To further improve the precision of diagnosis for individualizing care, the use of CP, GADA, genetic risk scores (GRS) or rare genetic variants of maturity onset of diabetes (MODY) can help doctors select the most appropriate therapy in a timely manner. While patients with low CP, GADA and high GRS will benefit from early insulin therapy, some MODY variants are associated with good response to insulin-releasing oral drugs (e.g. sulphonylurea) which may spare the use of insulin with reduced patient distress and over-insulinization. By contrast, patients with high CP often due to obesity-associated insulin resistance should undergo intensive lifestyle modification and use of drugs with weight-reducing or neutral effects to avoid weight gain due to excessive dose of insulin.
PART 1:
Objective: To characterize Chinese patients diabetes classified by fasting CP and GADA positivity and their prognostic significance.
Methods: Fasting CP levels and GADA in stored biosamples of 4000 patients in the Hong Kong Diabetes Register (HKDR) followed up since 1995.
PART 2:
Objective: To uncover genetic variants/sequences associated with familial YOD. Methods: Whole genome sequencing (WGS) in stored DNA of 100-120 sibpairs of YOD after 13 years of follow-up for imputation with exome data of case-control cohort of YOD and genome wide association studies (GWAS) data of 200 YOD families and 6000 T2D patients.
PART 3:
Objectives: To examine the impacts of precision medicine augmented by information technology and biogenetic markers (JADEPRISM) on attainment of cardiometabolic targets at 1 year and clinical outcomes at 3 year (n=440), compared with JADE-augmented care (n=440) in YOD.
Deliverables A catalogue of biogenetic markers to guide precision medicine augmented by the JADE-Technology to optimize clinical outcomes in YOD.
- Conditions
- Type 2 Diabetes
- Being tested
- Biogenetic explanation and endocrinologist intensive managment, Usual care management
- Keywords
- Young-onset type 2 diabetes
- 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.
Biogenetic explanation and endocrinologist intensive managmentOther
- JADE report and JADE APP
- Biogenetic explanation
- First-year intensive management by endocrinologists
- Follow up by their usual care doctors for continue treatment regimen maintenance.
- Yearly DM nurses follow up for blood taking and questionnaires
Usual care managementOther
- JADE report and JADE APP
- Attend their usual care clinic for ongoing treatment
- Yearly DM nurses follow up for blood taking and questionnaires
| Study group | Role | What they receive |
|---|---|---|
| JADE-PRISM group | Other | Only applicable in part 3 which is a randomized controlled trial. Part 1 and part 2 are the prospective cohort studies. Receives: Other: Biogenetic explanation and endocrinologist intensive managment |
| JADE group | Other | Only applicable in part 3 which is a randomized controlled trial. Part 1 and part 2 are the prospective cohort studies. Receives: Other: Usual care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of C-Peptide (CP) and Glutamic Acid Decarboxylase Antibody (GADA) in Chinese adult patients with T2D (Part 1 of study)
Between 1995 to 2004, all patients in the HKDR had structured assessment with storage of blood samples (collected at registration) for future research purpose. We shall measure CP and GADA in 4000-5000 patients.
Measured: through study completion, an average of 4 years
The correlation of C-Peptide (CP) and Glutamic Acid Decarboxylase Antibody (GADA) on clinical outcomes (Part 1 of study)
Between 1995 to 2004, all patients in the HKDR had structured assessment with storage of blood samples (collected at registration) for future research purpose.
Measured: through study completion, an average of 4 years
Incidence of young-onset type 2 diabetes and its genetic susceptibility (Part 2 of study)
Between 1998 to 2013, subjects from the HKFDS and the community-based LKS cohort had storage of blood samples at registration.
Measured: through study completion, an average of 4 years
Incidence of any diabetes-related micro/macrovascular endpoints (Part 3 of study)
Incident including cardiovascular disease (coronary heart disease, congestive heart failure, stroke, peripheral artery disease), chronic kidney disease, all-cause death and/or incident/progression/remission of albuminuria, estimated glomerular filtration rate, retinopathy, visual acuity and sensory neuropathy
Measured: through study completion, an average of 4 year
Secondary outcomes (20)
The levels of CP and GADA and the number of genetic variants for disease prognositication and classification to guide precision medicine in YOD (Part 1 and 2 of study)
Measured: through study completion, an average of 4 years
The number of genetic variants for disease prognositication and classification to guide precision medicine in YOD (Part 1 and 2 of study)
Measured: through study completion, an average of 4 years
The number of novel targets and pathways for discovery of drug targets with companian diagnostics (Part 1 and 2 of study)
Measured: through study completion, an average of 4 years
The number of patients attaining ≥3 cardiometabolic risk factors (Part 3 of study)
Defined as A1c<6,2%, blood pressure<120/80 mmHg, LDL-C<1.8 mmol/L , triglyceride<1.2 mmol/L, waist circumference<80 cm in women <85 cm in men which has been shown to reduce cardiovascular-renal endpoint in the JDOIT- 3 Study compared to conventional targets (A1c<7%, BP<130/80, LDL-C<1.8 mmol/L, triglyceride <1.7 mmol/L)
Measured: through study completion, an average of 4 years
Incidence of severe hypoglycaemia (Part 3 of study)
Defined as hospitalization due to hypoglycaemia
Measured: through study completion, an average of 4 year
Rate of changes in glycaemic control (Part 3 of study)
changes in HbA1c
Measured: through study completion, an average of 4 year
On-treatment changes in blood pressure (Part 3 of study)
measure both systolic and diastolic blood pressure in mmHg
Measured: through study completion, an average of 4 year
On-treatment changes in lipid profiles (Part 3 of study)
measure the changes in Total cholesterol, Triglyceride, High-density lipo-protein cholesterol, Low-density lipo-protein cholesterol
Measured: through study completion, an average of 4 year
On-treatment changes in Body Mass Index (Part 3 of study)
Measure by BW in kg
Measured: through study completion, an average of 4 year
On-treatment changes in CP (Part 3 of study)
Measure by changes in C-peptide
Measured: through study completion, an average of 4 year
Rate of changes in use of medications (Part 3 of study)
Measured: through study completion, an average of 4 year
Changes in patient's Quality of life (Part 3 of study)
Measure by questionnaire: EQ-5D For Quality of life (Total 5 questions with total score 1-15, highest score indicates the worst outcome)
Measured: through study completion, an average of 4 year
Changes in patient's reported outcomes : Depression (Part 3 of study)
Measure by questionnaire: PHQ-9 For Depression (Total 9 questions with total score 0-27, highest score indicates the worst outcome)
Measured: through study completion, an average of 4 year
Changes in patient's compliance (Part 3 of study)
Measure by questionnaire: CQ-4 For Compliance (Total 4 questions with total score 0-4, highest score indicates the worst outcome)
Measured: through study completion, an average of 4 year
Changes in patient's diabetes empowerment (Part 3 of study)
Measure by Diabetes Empowerment Scale (DES-20 for efficacy) (Total 20 questions with total score 0-80, highest score indicates better outcome)
Measured: through study completion, an average of 4 year
Changes in patient's diabetes self care activities (Part 3 of study)
Measure by questionnaire: Summary of diabetes self care activities (SDSCA-15 For self care) (Total 15 questions with total score 0-105, highest score indicates better outcome)
Measured: through study completion, an average of 4 year
Changes in patient's perceived personal control (Part 3 of study)
Measure by Perceived personal control (PPC) questionnaire (Total 9 questions with total score 0-18, highest score indicates better outcome)
Measured: through study completion, an average of 4 year
Changes in patient's genetic counseling satisfaction (Part 3 of study)
Measure by Genetic counseling satisfaction scale (GCSS) (Total 6 questions with total score 1-30, highest score indicates better outcome)
Measured: through study completion, an average of 4 year
Changes in patient's diabetes related distress (Part 3 of study)
Measures by questionnaire: Diabetes Distress Scale (DDS; total score from 17-102), comprising 3 subscales namely emotional, physician, regimen / social support. A lower score indicates better outcome
Measured: through study completion, an average of 4 year
Changes in patient's Depression Anxiety Stress (Part 3 of study)
Measure by Depression Anxiety Stress Scale (DASS-21) (Total 21 questions with total score 0-63, lowest score indicates better outcome)
Measured: through study completion, an average of 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start14 Jan 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 884 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Chan, Chinese University of Hong Kong
- Investigators
- Juliana Chan, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049149
- Sponsor's protocol ID
- CRE-2019.080
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
O CK, Fan YN, Fan B, Lim C, Lau ESH, Tsoi STF, Wan R, Lai WY, Poon EW, Ho J, Ho CCY, Fung C, Lee EK, Wong SY, Wang M, Ozaki R, Cheung E, Ma RCW, Chow E, Kong APS, Luk A, Chan JCN. Precision Medicine to Redefine Insulin Secretion and Monogenic Diabetes-Randomized Controlled Trial (PRISM-RCT) in Chinese patients with young-onset diabetes: design, methods and baseline characteristics. BMJ Open Diabetes Res Care. 2024 Jun 19;12(3):e004120. doi: 10.1136/bmjdrc-2024-004120.
PubMed 38901858
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine to Redefine Insulin Secretion and Monogenic Diabetes (PRISM) in Chinese Patients With Young Onset Diabetes
- ClinicalTrials.gov ID
- NCT04049149
- Acronym / sponsor ID
- CRE-2019.080
- Conditions
- Type 2 Diabetes
- Keywords
- Young-onset type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 884 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Aug 2019 (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.
Patients with young onset diabetes (YOD) are one of the most challenging groups of patients due to their long disease duration, complex causes, delayed interventions, psychosocial stress, poor adherence and frequent default. The investigator's previous studies indicate that provision of biogenetic information improved satisfaction, reduced ambiguity and improved self-efficacy in patients with T2D. Provision of personalized information using the web-based Joint Asia Diabetes Evaluation (JADE) Technology with risk stratification and decision support empowers better self care and medical intervention with improved control of risk factors. To further improve the precision of diagnosis for individualizing care, the use of CP, GADA, genetic risk scores (GRS) or rare genetic variants of maturity onset of diabetes (MODY) can help doctors select the most appropriate therapy in a timely manner. While patients with low CP, GADA and high GRS will benefit from early insulin therapy, some MODY variants are associated with good response to insulin-releasing oral drugs (e.g. sulphonylurea) which may spare the use of insulin with reduced patient distress and over-insulinization. By contrast, patients with high CP often due to obesity-associated insulin resistance should undergo intensive lifestyle modification and use of drugs with weight-reducing or neutral effects to avoid weight gain due to excessive dose of insulin.
Detailed description
Patients with young onset diabetes (YOD) are one of the most challenging groups of patients due to their long disease duration, complex causes, delayed interventions, psychosocial stress, poor adherence and frequent default. The investigator's previous studies indicate that provision of biogenetic information improved satisfaction, reduced ambiguity and improved self-efficacy in patients with T2D. Provision of personalized information using the web-based Joint Asia Diabetes Evaluation (JADE) Technology with risk stratification and decision support empowers better self care and medical intervention with improved control of risk factors. To further improve the precision of diagnosis for individualizing care, the use of CP, GADA, genetic risk scores (GRS) or rare genetic variants of maturity onset of diabetes (MODY) can help doctors select the most appropriate therapy in a timely manner. While patients with low CP, GADA and high GRS will benefit from early insulin therapy, some MODY variants are associated with good response to insulin-releasing oral drugs (e.g. sulphonylurea) which may spare the use of insulin with reduced patient distress and over-insulinization. By contrast, patients with high CP often due to obesity-associated insulin resistance should undergo intensive lifestyle modification and use of drugs with weight-reducing or neutral effects to avoid weight gain due to excessive dose of insulin.
PART 1:
Objective: To characterize Chinese patients diabetes classified by fasting CP and GADA positivity and their prognostic significance.
Methods: Fasting CP levels and GADA in stored biosamples of 4000 patients in the Hong Kong Diabetes Register (HKDR) followed up since 1995.
PART 2:
Objective: To uncover genetic variants/sequences associated with familial YOD. Methods: Whole genome sequencing (WGS) in stored DNA of 100-120 sibpairs of YOD after 13 years of follow-up for imputation with exome data of case-control cohort of YOD and genome wide association studies (GWAS) data of 200 YOD families and 6000 T2D patients.
PART 3:
Objectives: To examine the impacts of precision medicine augmented by information technology and biogenetic markers (JADEPRISM) on attainment of cardiometabolic targets at 1 year and clinical outcomes at 3 year (n=440), compared with JADE-augmented care (n=440) in YOD.
Deliverables A catalogue of biogenetic markers to guide precision medicine augmented by the JADE-Technology to optimize clinical outcomes in YOD.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JADE-PRISM group | Other | Other: Biogenetic explanation and endocrinologist intensive managmentOnly applicable in part 3 which is a randomized controlled trial. Part 1 and part 2 are the prospective cohort studies. |
| JADE group | Other | Other: Usual care managementOnly applicable in part 3 which is a randomized controlled trial. Part 1 and part 2 are the prospective cohort studies. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Part 1: Prospective cohort of Chinese with type 2 diabetes
- Between 1995 and December 2004, 10,129 patients were assessed using structured protocol to esetablish the HKDR and of them, we have measured GADA and CP in 1400 patients with YOD. In this study, we shall measure CP and GADA in 4000 subjects from the HKDR with available GWAS data irrespective of their age of diagnosis. These samples were linked to our various databases by a unique identification code which will enable us to track the clinical outcomes including development of complications.
- Part 2: Family-based cohort of first-degree relatives of diabetic probands
- We shall utilize the resource of the HKDFS and control subjects to discover novel genetic variants of YOD. Subjects will be selected based on their status with or without diabetes. In 2012-2013, we ascertained the glycemic status of 365 siblings in the HKDFS and 452 participants of the community-based LKS cohort (aged 18-55 years) without diabetes at baseline (1998-2002).
- In this cohort, 167 participants (53.7%) with a family history of YOD, 68 participants (30.1%) with a family history of late onset diabetes and 40 (14.4%) participants without family history of diabetes developed diabetes. Amongst the 313 siblings with family history of YOD, 167 had diabetes at baseline or developed diabetes during follow up and 146 did not develop diabetes after 13 years giving 100-120 sibpairs for linkage analysis. These sequence data will be imputed with 500 YOD patients and 500 control subjects with exome data as well as 6000 patients in the HKDR with GWAS data for analysis for validation purpose.
Key exclusion criteria (5 listed)
- Subjects in the HKDR, HKFDS and LKS cohorts without or insuffiicent amount of biosamples for assays or sequencing.
- T1D, defined by presentation with diabetic ketoacidosis or insulin requirement within 6 months of diagnosis.
- Reduced life expectancy due to terminal illness or otherwise deemed not appropriate per discretion of the investigator
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 |
|---|---|---|
| Biogenetic explanation and endocrinologist intensive managment* JADE report and JADE APP * Biogenetic explanation * First-year intensive management by endocrinologists * Follow up by their usual care doctors for continue treatment regimen maintenance. * Yearly DM nurses follow up for blood taking and questionnaires | Other | JADE-PRISM group |
| Usual care management* JADE report and JADE APP * Attend their usual care clinic for ongoing treatment * Yearly DM nurses follow up for blood taking and questionnaires | Other | JADE group |
Primary outcome
Prevalence of C-Peptide (CP) and Glutamic Acid Decarboxylase Antibody (GADA) in Chinese adult patients with T2D (Part 1 of study)
Time frame: through study completion, an average of 4 years
Between 1995 to 2004, all patients in the HKDR had structured assessment with storage of blood samples (collected at registration) for future research purpose. We shall measure CP and GADA in 4000-5000 patients.
The correlation of C-Peptide (CP) and Glutamic Acid Decarboxylase Antibody (GADA) on clinical outcomes (Part 1 of study)
Time frame: through study completion, an average of 4 years
Between 1995 to 2004, all patients in the HKDR had structured assessment with storage of blood samples (collected at registration) for future research purpose.
Incidence of young-onset type 2 diabetes and its genetic susceptibility (Part 2 of study)
Time frame: through study completion, an average of 4 years
Between 1998 to 2013, subjects from the HKFDS and the community-based LKS cohort had storage of blood samples at registration.
Incidence of any diabetes-related micro/macrovascular endpoints (Part 3 of study)
Time frame: through study completion, an average of 4 year
Incident including cardiovascular disease (coronary heart disease, congestive heart failure, stroke, peripheral artery disease), chronic kidney disease, all-cause death and/or incident/progression/remission of albuminuria, estimated glomerular filtration rate, retinopathy, visual acuity and sensory neuropathy
20 secondary outcomes
The levels of CP and GADA and the number of genetic variants for disease prognositication and classification to guide precision medicine in YOD (Part 1 and 2 of study)
Time frame: through study completion, an average of 4 years
The number of genetic variants for disease prognositication and classification to guide precision medicine in YOD (Part 1 and 2 of study)
Time frame: through study completion, an average of 4 years
The number of novel targets and pathways for discovery of drug targets with companian diagnostics (Part 1 and 2 of study)
Time frame: through study completion, an average of 4 years
The number of patients attaining ≥3 cardiometabolic risk factors (Part 3 of study)
Time frame: through study completion, an average of 4 years
Incidence of severe hypoglycaemia (Part 3 of study)
Time frame: through study completion, an average of 4 year
Rate of changes in glycaemic control (Part 3 of study)
Time frame: through study completion, an average of 4 year
On-treatment changes in blood pressure (Part 3 of study)
Time frame: through study completion, an average of 4 year
On-treatment changes in lipid profiles (Part 3 of study)
Time frame: through study completion, an average of 4 year
On-treatment changes in Body Mass Index (Part 3 of study)
Time frame: through study completion, an average of 4 year
On-treatment changes in CP (Part 3 of study)
Time frame: through study completion, an average of 4 year
Rate of changes in use of medications (Part 3 of study)
Time frame: through study completion, an average of 4 year
Changes in patient's Quality of life (Part 3 of study)
Time frame: through study completion, an average of 4 year
Changes in patient's reported outcomes : Depression (Part 3 of study)
Time frame: through study completion, an average of 4 year
Changes in patient's compliance (Part 3 of study)
Time frame: through study completion, an average of 4 year
Changes in patient's diabetes empowerment (Part 3 of study)
Time frame: through study completion, an average of 4 year
Changes in patient's diabetes self care activities (Part 3 of study)
Time frame: through study completion, an average of 4 year
Changes in patient's perceived personal control (Part 3 of study)
Time frame: through study completion, an average of 4 year
Changes in patient's genetic counseling satisfaction (Part 3 of study)
Time frame: through study completion, an average of 4 year
Changes in patient's diabetes related distress (Part 3 of study)
Time frame: through study completion, an average of 4 year
Changes in patient's Depression Anxiety Stress (Part 3 of study)
Time frame: through study completion, an average of 4 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 38901858O CK, Fan YN, Fan B, Lim C, Lau ESH, Tsoi STF, Wan R, Lai WY, Poon EW, Ho J, Ho CCY, Fung C, Lee EK, Wong SY, Wang M, Ozaki R, Cheung E, Ma RCW, Chow E, Kong APS, Luk A, Chan JCN. Precision Medicine to Redefine Insulin Secretion and Monogenic Diabetes-Randomized Controlled Trial (PRISM-RCT) in Chinese patients with young-onset diabetes: design, methods and baseline characteristics. BMJ Open Diabetes Res Care. 2024 Jun 19;12(3):e004120. doi: 10.1136/bmjdrc-2024-004120.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Juliana Chan, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biogenetic explanation and endocrinologist intensive managment in people with Type 2 Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 11 inclusion and 5 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 20 Jul 2022. 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 Hong Kong. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of C-Peptide (CP) and Glutamic Acid Decarboxylase Antibody (GADA) in Chinese adult patients with T2D (Part 1 of study) (time frame: through study completion, an average of 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049149, which also lists 1 linked publication.
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 20 Jul 2022.