Effect of Probiotic Supplementation on Metabolic Inflammation in Prediabetic Obese Patients in A Tertiary Care Hospital: A Double Blind, Randomized, Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Improvement in prediabetic state by estimating FBS, PPBS and HbA1c
研究概览
简要总结
This MD thesis proposal aims to assess the impact of probiotic supplementation on metabolic inflammation in prediabetic obese patients. The study, with a sample size of 70, will evaluate glycemic control, insulin resistance, oxidative stress, and gut permeability. Participants will be randomized into probiotic and placebo groups, receiving treatment for 12 weeks, with regular follow-ups to monitor compliance and adverse effects. The study’s outcomes may contribute valuable insights to the limited body of randomized control trials on the gut microbiome’s role in prediabetes and obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Prediabetic patients Obesity patients.
排除标准
- •Known history of gastrointestinal malabsorption, chronic diarrhoea.
- •Antibiotic consumption or intestinal infection in 3 months Pregnancy, lactation, psychiatric patients.
结局指标
主要结局
Improvement in prediabetic state by estimating FBS, PPBS and HbA1c
时间窗: 12 weeks
次要结局
- 1.Improvement in insulin resistance by estimating TyG index, TG/HDL C ratio(2.Improvement in inflammation – TNF alpha, Malondialdehyde (MDA))
研究者
Arunkumar R
SRM Medical College Hospital and Research Centre
