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

Last updated: December 18, 2024
Sponsor: Tianjin Medical University General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Genetic Screening for Monogenic Diabetes

Clinical Study ID

NCT06746610
IRB2022-YX-164-01
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diabetes patients who developed before 25 years old; Or they were diagnosed withdiabetes before the age of 35, and two or more immediate relatives were diagnosedwith 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 (ICAAb), and anti insulin autoantibody (IAA Ab) were all negative;

Exclusion

Exclusion Criteria:

  1. Secondary diabetes patients with other endocrine diseases, such as hyperthyroidismor hypothyroidism, hyperparathyroidism or hypothyroidism, acromegaly, Cushing'ssyndrome, autoimmune multiple endocrine diseases, etc.;

  2. Systemic use of corticosteroids, immunosuppressants, and other drugs within the past 6 months;

  3. Patients with malignant tumors.

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: Genetic Screening for Monogenic Diabetes
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Active - Recruiting

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