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

NCT07621445 | Recruiting DMC

• 1 other identifier: 2025 T1DGRS LYF20250124
• Study Type: observational
• Target: 2,950
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Keywords

Genetic risk score

Outcome Measures

Primary Outcomes (1)

• C-peptide

  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;

  "baseline"、"third year"

Secondary Outcomes (3)

• Fasting and 2 - hour blood glucose

  "baseline"、"third year"

• Glycosylated hemoglobin

  "baseline"、"third year"

• Whether insulin treatment is needed

  "baseline"、"third year"

Study Arms (2)

Patients with diabetes who 'progress to insulin deficiency and severe insulin deficiency'

Patients with diabetes who 'progress to insulin deficiency' and 'progress to severe insulin deficiency'

Patients who have not progressed to insulin deficiency

For each case, several controls (1:2) were randomly selected from patients in this cohort who had not progressed to insulin deficiency at the same follow - up time point.

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study will enroll newly-diagnosed diabetic patients whose clinical subtype is unclear. Participants must be aged between 14 and 50 years, with a diabetes diagnosis within the past year, confirmed by standard American Diabetes Association (ADA) criteria. A key pathophysiological criterion is a peak C-peptide level \< 200 pmol/L, suggesting impaired insulin secretion. Key Exclusion Criteria: Patients will be excluded for conditions that could confound the etiology of diabetes or pose additional risks, including: Specific diabetes subtypes (e.g., gestational diabetes, monogenic diabetes, pancreatic diseases). Comorbidities such as malignant tumors or severe organ dysfunction. Acute metabolic derangements (e.g., ketoacidosis). Conditions limiting life expectancy or ability to participate (e.g., expected survival \< 3 years, psychiatric disorders). Current pregnancy or lactation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

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

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Genetic Risk Score

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Metabolism and Endocrinology, Institute of Metabolism and Endocrinology, National Clinical Research Center for Endocrine and Metabolic Diseases, Second Xiangya Hospital, Central South University

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: June 2, 2026
• Study Start: October 27, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 2, 2026

Record last verified: 2026-02

Locations

CN (1)