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NCT Number: NCT07621445

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

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.

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Key information

Age range

14 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

Location status: Recruiting

Location contact

Yang Xiao, MD/PhD

CONTACT

[email protected]

86-0731-85292154

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gender is not restricted.
  • Age ranges from 14 to 50 years old.
  • Diagnosis of diabetes within < 1 year:
  • 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.
  • Newly - diagnosed diabetes patients whose type diagnosis is considered unclear clinically.

Exclusion criteria

  • 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;
  • Those with concurrent malignant tumors or severe heart, liver, and kidney diseases;
  • Those with an expected survival time of less than 3 years;
  • Those with mental disorders or unable to cooperate with the investigation for other reasons;
  • Acute phase of diabetic ketoacidosis;
  • Stress conditions such as severe infection, fever, trauma, and major surgery;
  • Patients lacking major clinical information;
  • Those considered by the researcher as unfit to participate in this study.

Treatment and study plan

Primary outcomes

  1. C-peptide

    Time frame: "baseline"、"third year"

    The primary endpoint is the occurrence of progression to insulin deficiency. Subjects who "progress to insulin deficiency" are defined as those whose C-peptide level drops to C-peptide < 250 pmol/L during the follow - up period;

Secondary outcomes

  1. Fasting and 2 - hour blood glucose

    Time frame: "baseline"、"third year"

  2. Glycosylated hemoglobin

    Time frame: "baseline"、"third year"

  3. Whether insulin treatment is needed

    Time frame: "baseline"、"third year"

    Collect the medical history and current medication information of the subjects.

Sponsors and collaborators

Lead sponsor

Second Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

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.

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