The Effects of Probiotics on Metabolic Biomarkers, Inflammation, and the Antioxidant System in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Efficacy of probiotics on inflammatory markers
研究概览
简要总结
Adult-onset diabetes is a disease characterized by high blood glucose levels and is one of the leading causes of cardiovascular disease, blindness, end-stage renal failure, and hospitalization. Recent studies support the idea that bacteria found in the gut may play an important role in the development and progression of diabetes. Changes in the gut bacterial environment can affect blood glucose and blood lipids. A increasing number of recent studies have shown that probiotics can alter the gut bacterial environment and reduce blood glucose and blood lipids. The aim of this study is to investigate the effects of probiotics, administered in addition to your current medications, on blood glucose and blood lipids.
详细描述
Participants aged 35-65 years diagnosed with T2DM were allocated sequentially according to order of presentation to either probiotic group (n=39) or control group (n=38). The intervention group received a multi-strain probiotic supplement containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis and Lactobacillus paracasei, twice daily for 12 weeks, while the control group continued standard care. This study evaluated anthropometric measurements, eating attitudes, dietary frequency, quality of life, and physical activity. Biochemical analyses included glycemic control, lipid profiles, inflammation markers (high-sensitivity C-Reactive Protein, Ceruloplasmin), and oxidative stress markers (Malondialdehyde, Glutathione).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 35-65 years
- •Previously diagnosed with T2DM
- •Volunteering to participate in this study.
排除标准
- •Use of any systemic antibiotics, multivitamins, minerals, herbal medicines, prebiotic, probiotic and postbiotic supplements in the last 3-6 months
- •Having a diagnosis of any inflammatory bowel disease, severe renal dysfunction or hepatic dysfunction, immunodeficiency diseases, acute infection, rheumatoid arthritis, cancer history
- •history of alcohol abuse or drug dependence,
- •pregnant or lactating women
研究组 & 干预措施
Probiotic group
Patients in the intervention group were given a probiotic supplement containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis and Lactobacillus paracasei, each containing 1.25 billion live microorganisms, without vitamins and minerals, twice a day in addition to their current treatment for 12 weeks.
干预措施: Probiotic group (Dietary Supplement)
Control group
Patients in the control group were not given any additional treatment and were allowed to continue their routine antidiabetic treatment for 12 weeks
结局指标
主要结局
Efficacy of probiotics on inflammatory markers
时间窗: From enrollment to the end of treatment at 12 weeks
hs-CRP
Efficacy of probiotics on antioxydant systems
时间窗: From enrollment to the end of treatment at 12 weeks
Glutathion
次要结局
- Efficacy of probiotics on glucose metabolism(From enrollment to the end of treatment at 12 weeks)
- Efficacy of probiotics on lipid metabolism(From enrollment to the end of treatment at 12 weeks)
研究者
Asli Kilavuz
Assoc. Prof., MD, PhD
Ege University