Based on a Randomized, Double-blind, Controlled Trial, Evaluate the Effects of Probiotics on Inflammation and Metabolism in Patients With Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Inflammatory markers
研究概览
简要总结
This clinical study aims to explore the effects of probiotics on inflammatory and metabolic indicators in patients with type 2 diabetes. By assessing the potential of probiotics to modify these markers, the study seeks to identify an economical and effective strategy for the prevention and treatment of type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed an informed consent form before the study and has a thorough understanding of the content, process, and possible adverse reactions of the study;
- •Age 18 (inclusive) and above, gender not limited;
- •Diagnosed with type 2 diabetes mellitus;
- •Not diagnosed with cardiovascular, kidney, or any other diabetic complications.
排除标准
- •Age over 75 years old;
- •Use of exogenous insulin or patients with cardiovascular disease and other complications;
- •Patients who are currently using α-glucosidase inhibitors;
- •Patients who have a habit of taking probiotics or are currently taking probiotics;
- •Pregnant or lactating women;
- •Subjects deemed unsuitable for participation in this clinical study by the investigators due to other reasons.
研究组 & 干预措施
Probiotics
Participants will receive a probiotic strip (3g/strip) daily alongside their standard clinical treatment for a continuous 12-week period.
干预措施: Probiotics (Dietary Supplement)
Maltodextrin
Participants will take a daily placebo strip (3g/strip) in addition to their regular clinical treatment over a continuous 12-week period.
干预措施: Probiotics (Dietary Supplement)
结局指标
主要结局
Inflammatory markers
时间窗: 12 weeks
Blood samples will be collected from patients with type 2 diabetes mellitus (T2DM), centrifuged to obtain serum, and analyzed for tumor necrosis factor-alpha (TNF-α), interleukins 6 (IL-6), 10 (IL-10), and 18 (IL-18), IL-1β, and interferon-gamma (IFN-γ) to assess the impact of probiotics on T2DM patients.
次要结局
未报告次要终点