- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06111833
Optimized Diagnosis and Precision Medicine of MODY
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:
- 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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yi-Jing Sheen, MD. PHD
- Phone Number: 4408 886-4-2359-2525
- Email: docmedjean@gmail.com
Study Locations
-
-
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Taichung, Taiwan, 407
- Recruiting
- Taichung Veterans General Hospital
-
Contact:
- Yi-Jing Sheen, MD. PHD
- Phone Number: 4408 886-4-2359-2525
- Email: docmedjean@gmail.com
-
Sub-Investigator:
- Wayne H-H Sheu, MD. PHD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Case (MODY)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose control
Time Frame: 3 months
|
serum concentration of Fasting glucose (mg/dl) HbA1C (%)
|
3 months
|
Genetic testing for evaluate the different types of MODY
Time Frame: 1 year
|
Genotype evaluate by WES: Pathogenic or likely pathogenic Vairants rate (%)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Renal function
Time Frame: 3 months
|
Concentration of urine albumin-creatinine ratio: UACR (mg/g); Serum creatinine mg/dL
|
3 months
|
Sudomotor function
Time Frame: 1 year
|
value of Electrochemical Skin Conductance: μS
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yi-Jing Sheen, MD. PHD, Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF23186B
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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