Optimized Diagnosis and Precision Medicine of MODY

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-22

Study Completion Date

2028-05-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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:

1. The distribution of different types of MODY
2. The phenotypes and clinical characteristics of different types of MODY
3. 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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes

NCT06746610

Monogenic Diabetes

RECRUITING NA

Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis

NCT07111416

Type 2 Diabetes

NOT_YET_RECRUITING

Genomic Study of Young-Onset Diabetes Mellitus

NCT06273059

Genomic Diabetes Mellitus MODY

RECRUITING

MODY in Young-onset Diabetes in Different Ethnicities

NCT02082132

Diabetes Maturity Onset Diabetes of the Young Type 1 Diabetes +1 more

UNKNOWN

Identifying Maturity-onset Diabetes of the Young in Emirati Patients

NCT05586594

Maturity-onset Diabetes of the Young Monogenic Diabetes MODY

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Maturity-Onset Diabetes of the Young (MODY) Type 2 Diabetes Diabetes Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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.
2. 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.
3. 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.

Exclusion Criteria

1. Confirmed Diagnosed with type 1 diabetes.
2. Under 18 years of age.
3. Unable to personally provide informed consent.
4. Patients with unrelieved leukemia.
5. Patients who have undergone chemotherapy or radiation therapy for cancer within the last 12 months.
6. Cases that have received a blood transfusion within the last six months.
7. Unwilling or unable to continue treatment follow-up at this hospital.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No