Maturity-Onset Diabetes of the Young (MODY)NCT06111833
Optimized Diagnosis and Precision Medicine of MODY
An observational study of Maturity-Onset Diabetes of the Young (MODY) and Type 2 Diabetes, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
The goal of this observation is to establish a complete registry for the clinical manifestations, environment, genetic, and other related gene variation information of young-onset diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maturity-Onset Diabetes of the Young (MODY), Type 2 Diabetes, Diabetes Complications
- How many people
- 1,500 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 May 2023to 21 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with young-onset diabetes who receive regular follow-ups at TCVGH and provide informed consent after fully understanding the study's requirements. Additionally, direct blood relatives of the case group, including brothers and sisters, who have contacted the research team through the subjects, and have expressed their willingness to participate in this study after granting informed consent
Who may be able to join
- Case Group Diagnosis of diabetes at or before 25 years of age. BMI (Body Mass Index) of 25 kg/m² or lower. Having at least one parent diagnosed with type 2 diabetes.
- Family Group Direct blood relatives of the case group, including brothers and sisters of the case group, who have contacted the research team through the subjects.
- Expressing willingness to participate in this study after granting informed consent.
- Control Group Diagnosis of diabetes occurred at or before the age of 40, and the individual lacks typical MODY (Maturity-Onset Diabetes of the Young) characteristics.
- At least one parent has been diagnosed with type 2 diabetes.
Who cannot join
- Confirmed Diagnosed with type 1 diabetes.
- Under 18 years of age.
- Unable to personally provide informed consent.
- Patients with unrelieved leukemia.
- Patients who have undergone chemotherapy or radiation therapy for cancer within the last 12 months.
- Cases that have received a blood transfusion within the last six months.
- Unwilling or unable to continue treatment follow-up at this hospital.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung veterans general hospital
Taichung, 407
Yi-Jing Sheen, MD. PHD, 886-4-2359-2525 ext. 4408, docmedjean@gmail.com
Wayne H-H Sheu, MD. PHD
About this study
Official title: Optimized Diagnosis and Precision Medicine of MODY (Maturity-Onset Diabetes of the Young)
The goal of this observation is to establish a complete registry for the clinical manifestations, environment, genetic, and other related gene variation information of young-onset diabetic patients. Moreover, according to the physiological and pathological mechanisms of different genes, the impact on the clinical characteristics of diabetes, the therapeutic response to drugs, and the impact on complications will be analyzed.
The main questions are:
Read more
- The distribution of different types of MODY
- The phenotypes and clinical characteristics of different types of MODY
- Response to antidiabetic drugs among different types of MODY
Once the participant is enrolled, their questionnaire information (including disease course and development, health history, family history, drug history, etc.), medication, outpatient/inpatient medical history, etc. will be collected and logged in. Blood and urine samples will also be collected for biochemical tests genetic testing, etc.
At the same time, the investigators will conduct a continuous follow-up on a regular basis (3 months, 6 months, 12 months, 24 months, and 5 years after the study subject is enrolled).
Young-onset type 2 diabetes will be compared to see the difference in clinical presentations and responses to antidiabetic drugs.
Read the detailed description
Diabetes and its complications rank among the top ten death causes in Taiwan. In Taiwan, besides the high prevalence, diabetes also shows a trend in younger people. Compared with type 2 diabetes which typically develops at older ages, young-onset diabetes (YOD) has a faster decline in the function of islet cells and a higher risk of complications. These young-onset diabetic patients may belong to different subtypes, and each subtype has different clinical manifestations or genetic characteristics, while the physiological and pathological mechanisms behind them are very complex and closely affect the subsequent treatment decisions. Among young-onset diabetes, maturity-onset diabetes of the young (MODY) has the most obvious genetic predisposition and family history. If the diagnosis is confirmed, it may be possible to directly target the unique defect of the relevant gene and accurately select the appropriate drug therapy to help patients achieve good blood sugar control as soon as possible. This five-year proposal is aimed to target 1,500 young-onset diabetic patients (case group) as well as 500 young-onset, but not MODY, diabetic patients (control group). Once the study subject is enrolled, their questionnaire information (including disease course and development, health history, family history, drug history, etc.), medication, outpatient/inpatient medical history, etc. will be collected and logged in. Blood and urine samples will also be collected for biochemical tests genetic testing, etc. At the same time, the investigators will conduct a continuous follow-up on a regular basis (3 months, 6 months, 12 months, 24 months, and 5 years after the study subject is enrolled). The aim of this proposal is to establish a complete registry for the clinical manifestations, environment, genetic, and other related gene variation information of young-onset diabetic patients. Moreover, according to the physiological and pathological mechanisms of different genes, the impact on the clinical characteristics of diabetes, the therapeutic response to drugs, and the impact on complications will be analyzed. It is expected that different subtypes of early-onset diabetes can be established for genetic counseling, prevention, health education, and treatment selection strategies to achieve good blood sugar and other metabolic control in time, so as to achieve individualized precision medical prevention and treatment.
- Medical subject headings
- Mason-Type Diabetes, Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case (MODY) | 1. Age at diagnosis of diabetes ≤ 25 years old; and 2. BMI ≤ 25kg/m2; and 3. At least one parent suffers from type 2 diabetes | |
| Family | Direct blood relatives/brothers and sisters of the Case group, who have contacted the research team through the subjects and are willing to participate in this study after giving full informed consent. | |
| Control | 1. Age at diagnosis of diabetes ≤ 40 years old, and without typical MODY characteristics 2. At least one parent suffers from type 2 diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose control
serum concentration of Fasting glucose (mg/dl) HbA1C (%)
Measured: 3 months
Genetic testing for evaluate the different types of MODY
Genotype evaluate by WES: Pathogenic or likely pathogenic Vairants rate (%)
Measured: 1 year
Secondary outcomes (2)
Renal function
Concentration of urine albumin-creatinine ratio: UACR (mg/g); Serum creatinine mg/dL
Measured: 3 months
Sudomotor function
value of Electrochemical Skin Conductance: μS
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start22 May 2023
- Primary completion21 Apr 2028 (estimated)
- Study completion21 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maturity-Onset Diabetes of the Young (MODY)Studies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
- Investigators
- Yi-Jing Sheen, MD. PHD, Principal investigator, Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111833
- Sponsor's protocol ID
- CF23186B
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Diagnosis and Precision Medicine of MODY (Maturity-Onset Diabetes of the Young)
- ClinicalTrials.gov ID
- NCT06111833
- Acronym / sponsor ID
- CF23186B
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 22 May 2023 (actual)
- Primary completion
- 21 Apr 2028 (estimated)
- Study completion
- 21 May 2028 (estimated)
- First posted
- 1 Nov 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 goal of this observation is to establish a complete registry for the clinical manifestations, environment, genetic, and other related gene variation information of young-onset diabetic patients. Moreover, according to the physiological and pathological mechanisms of different genes, the impact on the clinical characteristics of diabetes, the therapeutic response to drugs, and the impact on complications will be analyzed.
The main questions are:
- The distribution of different types of MODY
- The phenotypes and clinical characteristics of different types of MODY
- Response to antidiabetic drugs among different types of MODY
Once the participant is enrolled, their questionnaire information (including disease course and development, health history, family history, drug history, etc.), medication, outpatient/inpatient medical history, etc. will be collected and logged in. Blood and urine samples will also be collected for biochemical tests genetic testing, etc.
At the same time, the investigators will conduct a continuous follow-up on a regular basis (3 months, 6 months, 12 months, 24 months, and 5 years after the study subject is enrolled).
Young-onset type 2 diabetes will be compared to see the difference in clinical presentations and responses to antidiabetic drugs.
Detailed description
Diabetes and its complications rank among the top ten death causes in Taiwan. In Taiwan, besides the high prevalence, diabetes also shows a trend in younger people. Compared with type 2 diabetes which typically develops at older ages, young-onset diabetes (YOD) has a faster decline in the function of islet cells and a higher risk of complications. These young-onset diabetic patients may belong to different subtypes, and each subtype has different clinical manifestations or genetic characteristics, while the physiological and pathological mechanisms behind them are very complex and closely affect the subsequent treatment decisions. Among young-onset diabetes, maturity-onset diabetes of the young (MODY) has the most obvious genetic predisposition and family history. If the diagnosis is confirmed, it may be possible to directly target the unique defect of the relevant gene and accurately select the appropriate drug therapy to help patients achieve good blood sugar control as soon as possible. This five-year proposal is aimed to target 1,500 young-onset diabetic patients (case group) as well as 500 young-onset, but not MODY, diabetic patients (control group). Once the study subject is enrolled, their questionnaire information (including disease course and development, health history, family history, drug history, etc.), medication, outpatient/inpatient medical history, etc. will be collected and logged in. Blood and urine samples will also be collected for biochemical tests genetic testing, etc. At the same time, the investigators will conduct a continuous follow-up on a regular basis (3 months, 6 months, 12 months, 24 months, and 5 years after the study subject is enrolled). The aim of this proposal is to establish a complete registry for the clinical manifestations, environment, genetic, and other related gene variation information of young-onset diabetic patients. Moreover, according to the physiological and pathological mechanisms of different genes, the impact on the clinical characteristics of diabetes, the therapeutic response to drugs, and the impact on complications will be analyzed. It is expected that different subtypes of early-onset diabetes can be established for genetic counseling, prevention, health education, and treatment selection strategies to achieve good blood sugar and other metabolic control in time, so as to achieve individualized precision medical prevention and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case (MODY) | – | –1. Age at diagnosis of diabetes ≤ 25 years old; and 2. BMI ≤ 25kg/m2; and 3. At least one parent suffers from type 2 diabetes |
| Family | – | –Direct blood relatives/brothers and sisters of the Case group, who have contacted the research team through the subjects and are willing to participate in this study after giving full informed consent. |
| Control | – | –1. Age at diagnosis of diabetes ≤ 40 years old, and without typical MODY characteristics 2. At least one parent suffers from type 2 diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with young-onset diabetes who receive regular follow-ups at TCVGH and provide informed consent after fully understanding the study's requirements. Additionally, direct blood relatives of the case group, including brothers and sisters, who have contacted the research team through the subjects, and have expressed their willingness to participate in this study after granting informed consent
Key inclusion criteria (5 listed)
- Case Group Diagnosis of diabetes at or before 25 years of age. BMI (Body Mass Index) of 25 kg/m² or lower. Having at least one parent diagnosed with type 2 diabetes.
- Family Group Direct blood relatives of the case group, including brothers and sisters of the case group, who have contacted the research team through the subjects.
- Expressing willingness to participate in this study after granting informed consent.
- Control Group Diagnosis of diabetes occurred at or before the age of 40, and the individual lacks typical MODY (Maturity-Onset Diabetes of the Young) characteristics.
- At least one parent has been diagnosed with type 2 diabetes.
Key exclusion criteria (7 listed)
- Confirmed Diagnosed with type 1 diabetes.
- Under 18 years of age.
- Unable to personally provide informed consent.
- Patients with unrelieved leukemia.
- Patients who have undergone chemotherapy or radiation therapy for cancer within the last 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glucose control
Time frame: 3 months
serum concentration of Fasting glucose (mg/dl) HbA1C (%)
Genetic testing for evaluate the different types of MODY
Time frame: 1 year
Genotype evaluate by WES: Pathogenic or likely pathogenic Vairants rate (%)
2 secondary outcomes
Renal function
Time frame: 3 months
Sudomotor function
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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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.
Yi-Jing Sheen, MD. PHD principal investigator
Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
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 Maturity-Onset Diabetes of the Young (MODY) and Type 2 Diabetes, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 1 Nov 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Jing Sheen, MD. PHD (886-4-2359-2525 ext. 4408, docmedjean@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose control (time frame: 3 months). The study lists 2 primary outcomes in all. 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 1 Nov 2023.