Effect of Tributyrin Supplementation on Glycemic Control, Inflammation, and Cardiovascular Risk in Patients With Type 2 Diabetes
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: tributyrin, Placebo.
- Кому может быть актуально
- Состояния в реестре: Diabete Mellitus. Базовые параметры: 18 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
- Египет
- 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 evaluates the effectiveness and safety of tributyrin supplementation in patients with type 2 diabetes mellitus (T2DM) who are at increased risk of cardiovascular disease. Type 2 diabetes is commonly associated with poor blood sugar control, chronic inflammation, oxidative stress, and an increased risk of heart disease. Tributyrin is a dietary supplement that acts as a precursor to butyrate, a compound known for its anti-inflammatory and metabolic benefits. It may help improve blood sugar levels, reduce inflammation, and lower cardiovascular risk. In this randomized, double-blind, controlled clinical trial, participants will receive either tributyrin in addition to their standard diabetes treatment or standard therapy alone. The study will assess whether tributyrin improves glycemic control, inflammation, oxidative stress, lipid profile, and overall cardiovascular risk while maintaining safety and tolerability.
Подробное описание
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by hyperglycemia, insulin resistance, and progressive beta-cell dysfunction. It is strongly associated with chronic low-grade inflammation, oxidative stress, endothelial dysfunction, and an increased risk of atherosclerotic cardiovascular disease (ASCVD).
Short-chain fatty acids, particularly butyrate, have been shown to exert beneficial metabolic effects, including improving insulin sensitivity, reducing inflammation, and modulating oxidative stress. However, the clinical use of butyrate is limited by its poor bioavailability. Tributyrin, a triglyceride form of butyrate, serves as a prodrug that enhances absorption and provides sustained systemic release of butyrate.
Emerging evidence suggests that tributyrin may improve glycemic control, reduce inflammatory cytokines such as C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), enhance lipid metabolism, and improve endothelial function. Despite these promising findings, there is a lack of well-designed clinical trials evaluating its role in patients with T2DM, particularly those at elevated cardiovascular risk.
This study is a prospective, randomized, double-blind, controlled clinical trial conducted in adult patients with T2DM attending a diabetic outpatient clinic. Eligible participants will be randomly assigned in a 1:1 ratio to receive either oral tributyrin (500 mg twice daily) in addition to standard therapy or standard therapy alone for 12 weeks. Blinding will be maintained using identical capsules.
The primary objective is to evaluate the effect of tributyrin on glycemic control, assessed by fasting plasma glucose and glycated hemoglobin (HbA1c). Secondary objectives include assessment of inflammatory markers (CRP, IL-6, TNF-α), oxidative stress parameters (malondialdehyde and total antioxidant capacity), lipid profile (LDL-C, HDL-C, triglycerides), and estimated cardiovascular risk.
Safety outcomes will include monitoring of liver and renal function and the incidence of adverse events. Participants will be followed at regular intervals to assess treatment adherence, tolerability, and clinical response.
This study aims to determine whether tributyrin can serve as a safe and effective adjunctive therapy to improve metabolic control and reduce cardiovascular risk in patients with type 2 diabetes.
Вмешательства
- Препарат tributyrin
500 mg oral tributyrin twice daily for 12 weeks - Другое Placebo
Standard therapy alone
Первичные конечные точки
- Glycemic parameters [Срок оценки: week 12]
Вторичные конечные точки (3)
- lipid profile [Срок оценки: week 12]
- Inflammatory markers [Срок оценки: week 12]
- oxidative stress markers [Срок оценки: week 12]
Критерии участия
Критерии включения
- • Diagnosed with Type 2 DM for ≥ 1 year
- ASCVD 10-year risk ≥ 7.5%
- Stable antidiabetic and cardiovascular medication regimen for ≥ 3 months
- Able to provide informed consent and comply with study procedures
Критерии исключения
- • Established cardiovascular disease (history of MI, stroke, or revascularization)
- Chronic gastrointestinal disorders affecting absorption
- Severe hepatic or renal impairment
- Use of GLP-1 receptor agonists or SGLT2 inhibitors
- Pregnancy or lactation
- Known hypersensitivity to tributyrin or butyrate
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
- Четверное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Египет · 1 центр
- Matareya Teaching Hospital — Cairo
Публикации
- Ragheb SR, El Wakeel LM, Nasr MS, Sabri NA. Impact of Rutin and Vitamin C combination on oxidative stress and glycemic control in patients with type 2 diabetes. Clin Nutr ESPEN. 2020 Feb;35:128-135. doi: 10.1016/j.clnesp.2019.10.015. Epub 2019 Nov 14. PMID 31987106
Идентификаторы
NCT: NCT07503548 · HM000216