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

Tianjin Medical University General Hospital1 site in 1 country2,000 target enrollmentAugust 1, 2022

ConditionsMonogenic Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Monogenic Diabetes
Sponsor: Tianjin Medical University General Hospital
Enrollment: 2000
Locations: 1
Primary Endpoint: Genetic landscape of monogenic diabetes mellitus in China
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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. 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

Registry

clinicaltrials.gov

Start Date

August 1, 2022

End Date

July 31, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tianjin Medical University General Hospital

Responsible Party

Principal Investigator

Hua Shu

Attending Physician

Tianjin Medical University General Hospital

Eligibility Criteria

Inclusion Criteria

•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;

Exclusion Criteria

•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.