Monogenic DiabetesNCT06746610
Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes
A study testing Genetic Screening for Monogenic Diabetes in people with Monogenic Diabetes, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
The goal of this observational study is to establish a registry, screening, and individualized management platform for patients with monogenic diabetes mellitus(MDM) using internet-based and mobile application software. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Monogenic Diabetes
- What is being tested?
- Genetic Screening for Monogenic Diabetes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Jul 2027
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetes patients who developed before 25 years old; Or they were diagnosed with diabetes before the age of 35, and two or more immediate relatives were diagnosed with diabetes before the age of 45;
- Body mass index (BMI) at diagnosis < 28 kg/m2;
- Anti glutamic acid decarboxylase antibody (GAD Ab), anti islet cell antibody (ICA Ab), and anti insulin autoantibody (IAA Ab) were all negative;
Who cannot join
- Secondary diabetes patients with other endocrine diseases, such as hyperthyroidism or hypothyroidism, hyperparathyroidism or hypothyroidism, acromegaly, Cushing's syndrome, autoimmune multiple endocrine diseases, etc.;
- Systemic use of corticosteroids, immunosuppressants, and other drugs within the past 6 months;
- Patients with malignant tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
Ming Liu, +86 183 2201 7516, mingliu@tmu.edu.cn
About this study
The goal of this observational study is to establish a registry, screening, and individualized management platform for patients with monogenic diabetes mellitus(MDM) using internet-based and mobile application software. The main questions it aims to answer are:
- What are the genetic mutations causing MDM in China (genetic landscape)?
- How effective and safe is the individualized, molecular-diagnosis-based management platform for MDM in improving patient outcomes?
Read more
Participants will:
- Register in the MDM platform via mobile app or internet-based software
- Undergo genetic screening for MDM diagnosis
- Participate in follow-up visits for individualized management and monitoring of blood glucose control and outcomes
- Conditions
- Monogenic Diabetes
- Being tested
- Genetic Screening for Monogenic Diabetes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic Screening for Monogenic DiabetesDiagnostic test
This intervention involves genetic testing for monogenic diabetes (MDM) in recruited participants. The testing includes either a panel test specifically targeting genes associated with monogenic diabetes or whole exome sequencing (WES) to comprehensively identify genetic variants linked to MDM.
Precise diagnosis and treatmen：
- The clinical trial of individualized treatment was carried out for the individuals with diabetes with HNF1A mutation.
- The research team will closely follow up individuals with GCK mutation diabetes after suspending the current hypoglycemic drugs, and evaluate their clinical glucose metabolism related indicators.
- Observe the dosage of sulfonylurea drugs used in individuals with different disease course and pancreatic function, and observe the impact of disease course and pancreatic function on the success rate of oral drug replacement.
| Study group | Role | What they receive |
|---|---|---|
| Monogenic Diabetes Genetic Screening and Molecular Diagnosis | Other | Not described Receives: Diagnostic Test: Genetic Screening for Monogenic Diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic landscape of monogenic diabetes mellitus in China
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Aug 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monogenic DiabetesStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Shu, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746610
- Sponsor's protocol ID
- IRB2022-YX-164-01
- Status last verified
- Oct 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes
- ClinicalTrials.gov ID
- NCT06746610
- Acronym / sponsor ID
- IRB2022-YX-164-01
- Conditions
- Monogenic Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 24 Dec 2024 (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 observational study is to establish a registry, screening, and individualized management platform for patients with monogenic diabetes mellitus(MDM) using internet-based and mobile application software. The main questions it aims to answer are:
- What are the genetic mutations causing MDM in China (genetic landscape)?
- How effective and safe is the individualized, molecular-diagnosis-based management platform for MDM in improving patient outcomes?
Participants will:
- Register in the MDM platform via mobile app or internet-based software
- Undergo genetic screening for MDM diagnosis
- Participate in follow-up visits for individualized management and monitoring of blood glucose control and outcomes
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monogenic Diabetes Genetic Screening and Molecular Diagnosis | Other | Diagnostic Test: Genetic Screening for Monogenic Diabetes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetes patients who developed before 25 years old; Or they were diagnosed with diabetes before the age of 35, and two or more immediate relatives were diagnosed with diabetes before the age of 45;
- Body mass index (BMI) at diagnosis < 28 kg/m2;
- Anti glutamic acid decarboxylase antibody (GAD Ab), anti islet cell antibody (ICA Ab), and anti insulin autoantibody (IAA Ab) were all negative;
Key exclusion criteria (3 listed)
- Secondary diabetes patients with other endocrine diseases, such as hyperthyroidism or hypothyroidism, hyperparathyroidism or hypothyroidism, acromegaly, Cushing's syndrome, autoimmune multiple endocrine diseases, etc.;
- Systemic use of corticosteroids, immunosuppressants, and other drugs within the past 6 months;
- Patients with malignant tumors.
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 |
|---|---|---|
| Genetic Screening for Monogenic DiabetesThis intervention involves genetic testing for monogenic diabetes (MDM) in recruited participants. The testing includes either a panel test specifically targeting genes associated with monogenic diabetes or whole exome sequencing (WES) to comprehensively identify genetic variants linked to MDM. Precise diagnosis and treatmen： 1. The clinical trial of individualized treatment was carried out for the individuals with diabetes with HNF1A mutation. 2. The research team will closely follow up individuals with GCK mutation diabetes after suspending the current hypoglycemic drugs, and evaluate their clinical glucose metabolism related indicators. 3. Observe the dosage of sulfonylurea drugs used in individuals with different disease course and pancreatic function, and observe the impact of disease course and pancreatic function on the success rate of oral drug replacement. | Diagnostic test | Monogenic Diabetes Genetic Screening and Molecular Diagnosis |
Primary outcome
Genetic landscape of monogenic diabetes mellitus in China
Time frame: 24 months
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 24 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic Screening for Monogenic Diabetes in people with Monogenic Diabetes, run by Tianjin Medical University General Hospital at 1 site in China.
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 3 inclusion and 3 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 24 Dec 2024. 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 China. 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 Ming Liu (+86 183 2201 7516, mingliu@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic landscape of monogenic diabetes mellitus in China (time frame: 24 months). 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 24 Dec 2024.