- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT06273631
Влияние изменений в потреблении углеводов на контроль уровня глюкозы у больных сахарным диабетом 1 типа
Влияние изменений в потреблении углеводов на контроль уровня глюкозы у пациентов с диабетом 1 типа.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
1. Основная цель: оценить влияние изменений потребления углеводов на контроль уровня глюкозы у пациентов с диабетом 1 типа.
- Первичная конечная точка: разница во времени в диапазоне (TIR) между двумя группами.
- Вторичная конечная точка:
1) разница коэффициента вариации (CV), средней амплитуды отклонений гликемии (MAGE), большой амплитуды отклонений гликемии (LAGE) между двумя группами; 2) разница в изменении HbA1c, GA, 1,5-ангидроглюцита (1,5-AG) от исходного уровня между двумя группами; 3) разница в изменении частоты случаев гипогликемии (%), случаев тяжелой гипогликемии и ночных гипогликемий от исходного уровня между двумя группами; 4) разница изменения дозы инсулина (МЕ/кг/день) от исходного уровня между двумя группами.
2. Дополнительная цель: изучить возможный механизм диетического вмешательства для улучшения контроля уровня глюкозы в крови у пациентов с диабетом 1 типа.
- Влияние диетического вмешательства на микросреду и микрофлору кишечника у пациентов с диабетом 1 типа;
- Влияние диетического вмешательства на иммунную функцию пациентов с диабетом 1 типа;
- Влияние диетического вмешательства на метаболомику пациентов с диабетом 1 типа.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Tao Yang, MD/PhD
- Номер телефона: 6466 86-25-83718836
- Электронная почта: yangt@njmu.edu.cn
Места учебы
-
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Jiangsu
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Nanjing, Jiangsu, Китай, 210029
- Рекрутинг
- First Affiliated Hospital, Nanjing Medical University
-
Контакт:
- Tao Yang, PhD
- Номер телефона: 6466 86-25-83718836
- Электронная почта: yangt@njmu.edu.cn
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Критерии включения:
- Те, кто согласен участвовать в исследовании и подписывает информированное согласие;
- Диагностика сахарного диабета 1 типа (ADA2024);
- Возраст 18~65 лет;
- В зависимости от терапии экзогенным инсулином (CSII) план лечения остается неизменным в течение 2 мес (тип инсулина не может быть изменен, а доза может корректироваться в зависимости от уровня глюкозы в плазме);
- Индекс массы тела (ИМТ) 18~24 кг/м2;
- HbA1c ≤9,5%;
- Случайный С-пептид ≥200 пмоль/л.
Критерий исключения:
- Молодожены с сахарным диабетом 1 типа;
- Женщины, которые беременны или планируют забеременеть;
- Пациенты-вегетарианцы;
- Пациенты, применяющие пероральные гипогликемические препараты (ингибиторы альфа-глюкозидазы, ингибиторы ДПП-IV и др.);
- Пациенты, применяющие глюкокортикоиды в течение 30 дней;
- В анамнезе тяжелая пищевая аллергия;
- Пациенты с острыми осложнениями, такими как ДКА;
- Больные с гастропарезом, воспалительными заболеваниями кишечника и другими осложнениями;
- Пациенты с большой альбуминурией и почечной недостаточностью;
- Пациенты с неконтролируемым гипертиреозом и гипотиреозом;
- В анамнезе болезни сердца, ишемическая болезнь сердца и аритмии;
- Серьезные нарушения функции печени (АЛТ или АСТ>1,5 раза превышают верхнюю границу нормы);
- Злокачественные опухоли в анамнезе, другие неконтролируемые заболевания иммунной системы, неконтролируемые инфекции;
- Злоупотребление алкоголем, психические расстройства или другие состояния, не позволяющие быть наблюдателем при тестировании на наркотики;
- Пациенты с любым заболеванием, которое может помешать участию в исследовании или его оценке.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: diverse carbohydrate diet
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 45-50% are derived from refined grains and 45-50% from whole grains and legumes. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%. |
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively.
Of the staple carbohydrate sources, 45-50% are derived from refined grains and 45-50% from whole grains and legumes.
Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
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Другой: moderate carbohydrate diet
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 90-95% are derived from refined grains. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%. |
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively.
Of the staple carbohydrate sources, 90-95% are derived from refined grains.
Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Time in range (TIR)
Временное ограничение: 4 weeks (2 weeks after randomization)
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TIR is defined as the percentage of time that glucose levels are between 3.9 and 10.0 mmol/L, as measured by continuous glucose monitoring (CGM).
TIR at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Time above range(TAR)
Временное ограничение: 4 weeks (2 weeks after randomization)
|
TAR is defined as the percentage of time that glucose levels are above 10.0 mmol/L, as measured using continuous glucose monitoring (CGM).
TAR at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Time below range(TBR)
Временное ограничение: 4 weeks (2 weeks after randomization)
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TBR is defined as the percentage of time that glucose levels are below 3.9 mmol/L, as measured using continuous glucose monitoring (CGM).
TBR at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Mean glucose (MG)
Временное ограничение: 4 weeks (2 weeks after randomization)
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Mean glucose is defined as the arithmetic mean of all valid glucose values recorded during the 2-week continuous glucose monitoring (CGM) period.
Mean glucose at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Standard deviation of glucose (SD)
Временное ограничение: 4 weeks (2 weeks after randomization)
|
SD is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
SD at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Glucose coefficient of variation (CV)
Временное ограничение: 4 weeks (2 weeks after randomization)
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CV is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
CV at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Mean amplitude of glycemic excursions (MAGE)
Временное ограничение: 4 weeks (2 weeks after randomization)
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MAGE is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
MAGE at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Largest amplitude of glycemic excursions (LAGE)
Временное ограничение: 4 weeks (2 weeks after randomization)
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LAGE is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
LAGE at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Glycated albumin (GA)
Временное ограничение: 4 weeks (2 weeks after randomization)
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Glycated albumin will be measured at the end of the 2-week dietary intervention and compared between the two groups.
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4 weeks (2 weeks after randomization)
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Glycated hemoglobin A1c (HbA1c)
Временное ограничение: 16 weeks (14 weeks after randomization)
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HbA1c will be measured at the end of the follow-up period and compared between the two groups.
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16 weeks (14 weeks after randomization)
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C-peptide area under the curve (AUC C-peptide)
Временное ограничение: 16 weeks (14 weeks after randomization)
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C-peptide area under the curve will be assessed during a 3-hour mixed-meal tolerance test and calculated using the trapezoidal rule.
The assessment will be performed in participants with fasting C-peptide >80 pmol/L.
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16 weeks (14 weeks after randomization)
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Glucagon area under the curve (AUC glucagon)
Временное ограничение: 16 weeks (14 weeks after randomization)
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Glucagon area under the curve will be assessed during a 3-hour mixed-meal tolerance test and calculated using the trapezoidal rule.
The assessment will be performed in participants with fasting C-peptide >80 pmol/L.
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16 weeks (14 weeks after randomization)
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Fasting blood glucose (FBG)
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Fasting blood glucose will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total cholesterol (TC)
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total cholesterol will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Triglycerides (TG)
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Triglycerides will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Low-density lipoprotein cholesterol (LDL-C)
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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LDL-C will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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High-density lipoprotein cholesterol (HDL-C)
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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HDL-C will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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1,5-Anhydroglucitol (1,5-AG)
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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1,5-AG will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total daily insulin dose
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total daily insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Basal insulin dose
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Basal insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Prandial insulin dose
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Prandial insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Body weight
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Body weight will be measured at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist circumference
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Hip circumference
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Hip circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist-to-hip ratio (WHR)
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Waist-to-hip ratio will be calculated from waist and hip circumference measurements at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Body composition
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Body composition will be assessed using a body composition analyzer at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Hypoglycemic events
Временное ограничение: From randomization to the end of follow-up at 16 weeks
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Hypoglycemic events will be assessed by the number of events per participant, the proportion of participants experiencing at least one hypoglycemic event, and the incidence rate of hypoglycemic events.
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From randomization to the end of follow-up at 16 weeks
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Diabetic ketoacidosis (DKA)
Временное ограничение: From randomization to the end of follow-up at 16 weeks
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The number and proportion of participants experiencing diabetic ketoacidosis will be assessed and compared between the two groups.
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From randomization to the end of follow-up at 16 weeks
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Gut microbiota profile
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Gut microbiota profiles will be assessed from fecal samples at the end of the dietary intervention and at the end of the follow-up period to evaluate differences between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Metabolomic profile
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Metabolomic profiles will be assessed at the end of the dietary intervention and at the end of the follow-up period to evaluate differences between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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T-cell subset proportions
Временное ограничение: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
The proportions of T-cell subsets will be assessed by flow cytometry at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Tao Yang, MD/PhD, First Affiliated Hospital, Nanjing Medical University, China
Публикации и полезные ссылки
Общие публикации
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Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2022-SR-481.A3
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .