Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06746610

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Monogenic Diabetes

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Genetic Screening for Monogenic Diabetes

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：

  • 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.

Primary outcomes

  1. Genetic landscape of monogenic diabetes mellitus in China

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Ming Liu

CONTACT

[email protected]

+86 183 2201 7516

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.