Genetic Risk Score of Type 1 Diabetes Mellitus for Progression to Insulin in Diabetic Patients Lack of Predictive Value: a Multicenter Nested Case-control Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-50
SponsorSecond Xiangya Hospital of Central South University

About this trial

The goal of this observational study is to evaluate the predictive value of the genetic risk score for type 1 diabetes in the progression to insulin deficiency in diabetic patients. The main question it aims to answer is:

1. To investigate the predictive efficacy of the genetic risk score for T1DM in determining whether diabetic patients will progress to insulin deficiency; 2. To compare the differences in genetic characteristics between the insulin-deficient cohort and the non-insulin-deficient cohort.

This study is a nested case-control study, in which a case group and a control group are set up for the collection of observational indicators. Case group: Diabetic patients who "progressed to insulin deficiency" and those who "progressed to severe insulin deficiency". Control group: Patients who did not progress to insulin deficiency. The study period is 3 years.

Eligibility criteria

Qualifiers

Gender is not restricted.

Age ranges from 14 to 50 years old.

If there are diabetes symptoms and meet any of the following criteria:① Plasma glucose at any time ≥ 11.1 mmol/L (200 mg/dL), or② Fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL), or③ Plasma glucose 2 hours after OGTT/post - meal ≥ 11.1 mmol/L (200 mg/dL), or④ HbA1c ≥ 6.5%.

If there are no diabetes symptoms, another test on a different day is required for diagnosis.

Disqualifiers

Peak C-peptide < 200 pmol/L;

Gestational diabetes, monogenic diabetes (neonatal diabetes, MODY), exocrine pancreatic diseases (cystic fibrosis), diabetes caused by drugs or chemicals;

Those who have been under long-term treatment with hormones or immunosuppressants;

Pregnant or lactating women;

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

2,950 Participants
are grouped into 2 trial groups

Locations

1
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University410011, ChangshaHunan, China

Sponsors and collaborators

Second Xiangya Hospital of Central South University

Lead sponsor