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Набор по приглашению NCT06959784

Assessing Incretin Therapy for Cardiovascular Risk Reduction and Diabetes Remission( ITCRDR Study)

Фаза IV С лечением Diabetes Mellitus Cardiovascular Diseases Cerebrovascular Disease

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: semaglutide, Metformin.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Cardiovascular Diseases, Cerebrovascular Disease. Базовые параметры: 30 лет — 70 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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Официальное название

Evidence Based Evaluation of Incretin Drugs in Reducing the Risk of Cardiovascular and Cerebrovascular Events and Promoting the Remission of Diabetes

Обзор

This study used the diabetes prevention and follow-up research queue in Daqing and the public database of UKbiobank to evaluate the risk factors of cardiovascular and cerebrovascular events in diabetes patients, and built the first risk prediction model of cardiovascular and cerebrovascular events in diabetes patients based on the Chinese population follow-up queue and externally verified, so as to identify high-risk groups and guide the early prevention of cardiovascular and cerebrovascular diseases in diabetes patients. To evaluate the effect of incretin drugs on reducing the risk of cardiovascular and cerebrovascular events, and the impact on the remission rate of diabetes in people with initial diabetes, a randomized, multicenter, controlled clinical study was conducted. The long-term follow-up of 2 years was conducted to evaluate whether the cardiovascular and cerebrovascular risks of those who stopped drug treatment after remission of diabetes compared with those who continued drug treatment were reduced, as well as the long-term impact of incretin on cardiovascular and cerebrovascular risks and the role of long-term mitigation of diabetes.

Вмешательства

  • Препарат semaglutide
    The semaglutide intervention group received semaglutide (0.25 mg qw initially, increased to 0.5 mg qw after four weeks) for 24 weeks (6 months).
  • Препарат Metformin
    The metformin control group was treated with metformin (gradually increasing to 1g bid) for 24 weeks (6 months)

Первичные конечные точки

  • Cardiovascular and cerebrovascular event risk score [Срок оценки: One-year follow-up]
  • Major Adverse Cardiovascular Events [Срок оценки: Baseline and every 12 weeks until 96 weeks]
  • Cerebrovascular disease events [Срок оценки: Baseline and every 12 weeks until 96 weeks]
Вторичные конечные точки (12)
  • The remission rate of diabetes [Срок оценки: at 9 months, 1 year and 2 years of follow-up]
  • Glycated hemoglobin [Срок оценки: Baseline and every 12 weeks until 96 weeks]
  • Fasting and postprandial blood glucose levels [Срок оценки: at 2 year and 8 year of follow-up]
  • pancreatic islet function [Срок оценки: Baseline, 48 weeks and 96 weeks]
  • Heart rate [Срок оценки: Baseline, 48 weeks and 96 weeks]
  • Carotid artery peak systolic velocity [Срок оценки: Baseline, 48 weeks and 96 weeks]
  • Routine urine examination [Срок оценки: Baseline, 48 weeks and 96 weeks]
  • Urine microalbumin [Срок оценки: Baseline, 48 weeks and 96 weeks]
  • Heart rhythm [Срок оценки: Baseline, 48 weeks and 96 weeks]
  • Carotid artery peak diastolic velocity [Срок оценки: Baseline, 48 weeks and 96 weeks]
  • Carotid resistance index [Срок оценки: Baseline, 48 weeks and 96 weeks]
  • common carotid artery diameter [Срок оценки: Baseline, 48 weeks and 96 weeks]

Критерии участия

Критерии включения

  • Newly diagnosed diabetes, with no previous use of hypoglycemic medications or having discontinued such medications for more than 3 months.
  • Blood glucose elevation detected within one year (fasting blood glucose exceeding 7 mmol/L, postprandial blood glucose or random blood glucose exceeding 11.1 mmol/L).
  • Age between 30 and 70 years (inclusive of boundary values).
  • Hemoglobin A1c between 7% and 10% (inclusive of boundary values).
  • BMI between 24 and 32.5 kg/m² (inclusive of boundary values).

Критерии исключения

  • History of coronary heart disease or cerebral infarction.
  • Severe liver or kidney disease: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN); glomerular filtration rate less than 30 ml/min/1.73 m².
  • History of malignant tumors.
  • Use of systemic glucocorticoids (excluding local applications or inhalants) for one week or more within the three months prior to screening.
  • Positive urine pregnancy test in women of childbearing age.
  • History of pancreatitis, or amylase and/or lipase > 3 times the ULN.
  • Personal history or family history of medullary thyroid carcinoma (MTC) in first-degree relatives, or genetic predisposition to MTC (such as multiple endocrine neoplasia syndrome).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • China-Japan Friendship hospital — Пекин

Идентификаторы

NCT: NCT06959784 · 2024-1-4064 · 2024-1-4064

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗