Идёт набор NCT04883515

Effects of Oral Glutamine Supplementation on Insulin Resistance and Functional Intestinal Disorders in Obese Patients.

Без фазы С лечением Obesity Insulin Resistance

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: Oral glutamine supplementation, Oral protein powder supplementation, Insulin-resistance evaluation, Functional intestinal disorders evaluation.
Кому может быть актуально: Состояния в реестре: Obesity, Insulin Resistance. Базовые параметры: 18 лет — 65 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: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

Obesity, which has a prevalence at 15% in France, is a major public health concern. Altered glycemic control and irritable bowel syndrome (IBS) are frequently observed in obese patients and lead to reduce the quality of life. In the last decades, the role of gut microbiota and intestinal permeability has been underlined in obesity, glycemic control and IBS. Interestingly, experimental and clinical data show that glutamine, an amino acid, is able to maintain or restore intestinal permeability in different conditions. We thus hypothesize that oral glutamine supplementation may restore gut barrier function contributing to improve glycemic control and IBS-symptoms. Our project will thus aim to evaluate the effects of 8 weeks - oral glutamine supplementation on glycemic control and IBS symptoms in obese patients in a blinded randomized controlled trial. Placebo group will received protein powder. 55 obese patients will enrolled in each arm and will received oral glutamine supplementation or protein powder (10g t.i.d.) during 8 weeks. Blood and feces samples and intestinal permeability assays will be performed at baseline (w0), after 8 weeks of supplementation (w8) and then after 8 weeks of a wash-out period (w16).

Вмешательства

Пищевая добавка Oral glutamine supplementation
patient will receive oral glutamine supplementation 10 g Ter In Die during 8 weeks
Пищевая добавка Oral protein powder supplementation
patient will receive oral protein powder supplementation10 g Ter In Die during 8 weeks
Процедура Insulin-resistance evaluation
Homeostasic model assessment of insulin resistance test will be performed at baseline, Week 8 and Week 16
Процедура Functional intestinal disorders evaluation
Functional intestinal disorders will be measured by the IBS severity score and feces consistency by Bristol scale at baseline, Week 8 and Week 16

Первичные конечные точки

Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8 [Срок оценки: Week 8]

Вторичные конечные точки (6)

Change between Homeostasic model assessment of insulin resistance test value at baseline and week 16 [Срок оценки: Week 16]
Change between Homeostasic model assessment of insulin resistance test value at Week 8 and week 16 [Срок оценки: week 16]
Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 8 [Срок оценки: Week 8]
Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 16 [Срок оценки: Week 16]
Change between feces consistency at baseline and week 8 [Срок оценки: Week 8]
Change between feces consistency at baseline and week 16 [Срок оценки: Week 16]

Критерии участия

Критерии включения

Patients aged from 18 to 65 years
Patient with h grade II or III obesity (body mass index equal or higher than 35 kg/m2)
Patient with insulino-resistance (fasting glycaemia ≥ 1g/l et < 1.26 g/l)
Patient with irritable bowel syndrome (Rome IV criteria ≥ 2)