Идёт набор NCT07468474

Establishment of Screening Pathway for High-Risk Population of Type 1 Diabetes

— Наблюдательное Type 1 Diabetes Mellitus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Gene polymorphic detection.
Кому может быть актуально: Состояния в реестре: Type 1 Diabetes Mellitus. Базовые параметры: от 4 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study aims to establish a system for identifying and screening high-risk individuals for type 1 diabetes (T1D) and a standardized management pathway for high-risk individuals. It is a prospective cohort study. We plan to enroll 340 eligible subjects, including 40 healthy controls of the same gender and age, 150 T1D patients, and 150 first-degree relatives of T1D patients. The follow-up visit cycle for T1D patients and their first-degree relatives is 4 years. Blood samples will be collected annually for genetic polymorphism testing, pancreatic islet-related autoantibody measurement, blood glucose, hemoglobin A1c, and pancreatic function assessment. Urine samples will be collected for urine proteomics measurement. Fecal samples will be collected for fecal intestinal microbiota measurement. The value of pancreatic islet autoantibody markers in predicting T1D high-risk individuals will be evaluated, and a multi-gene risk score (PRS) prediction model will be established for subtypes of T1D, including acute and chronic T1D. A comprehensive T1D high-risk individual identification and screening system will be established and promoted for application.

Подробное описание

1. For patients with type 1 diabetes, the intervention includes two aspects: Firstly, at the time of subject enrollment, a 12-hour structured course is conducted, covering various aspects such as diabetes diet, exercise, blood sugar monitoring, insulin injection, complication prevention, and psychological adjustment. Secondly, regular outpatient follow-ups are carried out, with a frequency of once every 3 months. The follow-up content includes routine outpatient visit-related items, such as blood sugar, islet function, liver and kidney function, blood lipid, etc., as well as screening for diabetes complications. Follow-ups are conducted regularly based on the time of type 1 diabetes diagnosis. 2. For the first-degree relatives of patients with type 1 diabetes: At the time of subject enrollment, blood samples are taken for genetic polymorphism testing, islet-related autoantibody determination, blood sugar, glycosylated hemoglobin, and islet function assessment; urine samples are collected for urine proteomics determination. Stool samples are collected for stool intestinal flora determination. Subsequently, follow-ups are conducted once a year, with blood sampling and collection of urine and stool samples for the same items as in the baseline follow-up. 3. For healthy control populations, no follow-up arrangements are made. At the time of subject enrollment, blood samples are taken for genetic polymorphism testing, islet-related autoantibody determination, blood sugar, glycosylated hemoglobin, and islet function assessment; urine samples are collected for urine proteomics determination. Stool samples are collected for stool intestinal flora determination.

Вмешательства

Генная терапия Gene polymorphic detection
The follow-up visit period of T1D patients and their first-degree relatives was 4 years. Blood samples were collected every year for detection of gene polymorphism, determination of islet related autoantibodies, blood glucose, glycated hemoglobin, and islet function evaluation. Urine samples were collected for urinary proteomic determination. Stool samples were collected for the determination of stool intestinal flora.

Первичные конечные точки

Changes in HbA1c in patients with type 1 diabetes [Срок оценки: From enrollment to the end of the study at 1,2,3,4 years]
Ther differences in Albumin-to-Creatinine Ratio between type 1 diabetic patients and first-degree relatives and healthy control [Срок оценки: From enrollment to the end of the study at 1,2,3,4 years]
Ther differences in Genotype polymorphisms between type 1 diabetic patients and first-degree relatives and healthy control [Срок оценки: From enrollment to the end of the study at 1,2,3,4 years]
To establish screening and management paths for high-risk groups of type 1 diabetes patients [Срок оценки: up to 4 years]

Вторичные конечные точки (4)

Changes in disease self-management scores of patients with type 1 diabetes [Срок оценки: From enrollment to the end of the study at 1,2,3,4 years]
Changes of quality of life scores in patients with type 1 diabetes [Срок оценки: From enrollment to the end of the study at 1,2,3,4 years]
Changes of mood scale scores in patients with type 1 diabetes [Срок оценки: From enrollment to the end of the study at 1,2,3,4 years]
The decline in C-peptide levels in patients with type 1 diabetes [Срок оценки: From enrollment to the end of the study at 1,2,3,4 years]

Критерии участия

Inclusion and exclusion criteria for patients with type 1 diabetes:

Критерии включения

Meet the WHO's diabetes diagnostic criteria, diagnosed as type 1 diabetes; ② Able and willing to participate in 12 hours of structured education training;

Able and willing to undergo regular outpatient follow-up;

Volunteer to participate in the study and sign informed consent.

Критерии исключения

① Non-type 1 diabetic patients;

Severe microvascular complications: proliferative retinopathy; Urinary albumin/urinary creatinine > 300mg/g, or 24-hour urinary protein quantity > 1g/d; Uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy; ③ Patients who had acute cerebrovascular accident, acute coronary syndrome, peripheral artery disease requiring hospitalization or underwent vascular intervention or amputation within 3 months before enrollment; Blood pressure is consistently higher than 180/110mmHg and cannot be controlled within 160/110mmHg within 1 week; Serum creatinine clearance was less than 30ml/min/1.73m2(calculated according to CKDEPI formula), alanine aminotransferase ≥3 times the upper limit of normal, total bilirubin ≥2 times the upper limit of normal for more than 1 week;

(6) Have used drugs that may affect blood sugar for more than 1 week within 12 weeks, such as oral/intravenous glucocorticoids, growth hormones, estrogen/progesterone, high-dose diuretics, antipsychotic drugs, etc.; However, small doses of diuretics (hydrochlorothiazide < 25mg/d, indapamide ≤1.5mg/d) for antihypertensive purposes, and physiological dosages of thyroid hormones used for replacement therapy are not subject to this limit; (7) Systemic infection or serious concomitant disease; Patients with malignant tumors or chronic diarrhea; Other circumstances that cause the subjects to be unable to complete the study: such as serious cognitive dysfunction, mental illness, etc.;

⑨ The subject is uncooperative, unable to follow up, or the investigator judges that it may be difficult to complete the investigator;

⑩ Other conditions deemed unsuitable for inclusion by the investigator. The study physician will determine whether you are suitable for the study based on your actual condition and the inclusion and exclusion criteria in the study protocol.

(2) Inclusion and exclusion criteria for first-degree relatives of patients with type 1 diabetes:

Критерии включения

First-degree relatives of patients with type 1 diabetes (including parents, children, siblings);

Age ≥4 years old; ③ Able and willing to undergo regular outpatient follow-up; ④ Volunteer to participate in the study and sign informed consent.

Критерии исключения

Type 1 diabetes has been diagnosed;

Second degree relatives of patients with type 1 diabetes; ③ Patients who could not complete regular outpatient follow-up. (3) Inclusion and exclusion criteria for healthy people:

Критерии включения

Age ≥40 years old;

No history of diabetes; ③ Fasting blood glucose < 6.1mmol/L, 2-hour glucose load blood glucose < 7.8mmol /L, glycosylated hemoglobin < 5.7%; ④ Volunteer to participate in the study and sign informed consent.