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临床试验/CTRI/2024/07/071576
CTRI/2024/07/071576尚未招募4 期

Effect of Probiotic Supplementation on Metabolic Inflammation in Prediabetic Obese Patients in A Tertiary Care Hospital: A Double Blind, Randomized, Placebo Controlled Trial

Arunkumar R1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年8月1日最近更新:

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

发起方
Arunkumar R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Arunkumar R

SRM Medical College Hospital and Research Centre

研究点 (1)

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