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

NCT ID: NCT06746610

Last Updated: 2024-12-24

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2027-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Monogenic Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Monogenic Diabetes Genetic Screening and Molecular Diagnosis

Group Type OTHER

Genetic Screening for Monogenic Diabetes

Intervention Type DIAGNOSTIC_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：

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.

Interventions

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Genetic Screening for Monogenic Diabetes

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：

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. 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;
2. Body mass index (BMI) at diagnosis \< 28 kg/m2;
3. Anti glutamic acid decarboxylase antibody (GAD Ab), anti islet cell antibody (ICA Ab), and anti insulin autoantibody (IAA Ab) were all negative;

Exclusion Criteria

1. Secondary diabetes patients with other endocrine diseases, such as hyperthyroidism or hypothyroidism, hyperparathyroidism or hypothyroidism, acromegaly, Cushing's syndrome, autoimmune multiple endocrine diseases, etc.;
2. Systemic use of corticosteroids, immunosuppressants, and other drugs within the past 6 months;
3. Patients with malignant tumors.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hua Shu

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tianjin Medical University General Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ming Liu

Role: CONTACT

Phone: +86 183 2201 7516

Email: [email protected]

Facility Contacts

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Ming Liu

Role: primary

Other Identifiers

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IRB2022-YX-164-01

Identifier Type: -

Identifier Source: org_study_id