Effectiveness of Probiotics on improving Insulin Sensitivity among Prediabetic Obese South Indian Adult Population in teritary care hospital
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Improvement in insulin sensitivity as measured by HOMA-IR index.
研究概览
简要总结
Title
Effectiveness of Probiotics on Improving Insulin Sensitivity Among Prediabetic Obese South Indian Adults in a Tertiary Care Hospital A Randomized Controlled Trial
Background
India has rising rates of obesity, prediabetes, and diabetes.
The gut microbiome plays an important role in metabolism.
Probiotics, especially Lactobacillus strains, may improve insulin sensitivity and prevent progression from prediabetes to diabetes.
Indian data, especially from South India, is limited.
Objectives
Primary: To evaluate the effect of probiotic supplementation on insulin sensitivity (measured by HOMA-IR).
Secondary: To assess changes in fasting glucose, serum insulin, HbA1c, lipid profile, and to check safety/tolerability of probiotics.
Methods:
Design: Randomized, open-label, placebo-controlled clinical trial.
Setting: Puducherry tertiary care hospital.
Duration: 2 years (June 2025 – June 2027).
Participants: 150 obese (BMI more than or equal to 25 kg/m²), prediabetic adults aged more than 18 years.
Intervention:
Group A: Probiotic capsules (containing Bacillus mesentricus, Lactobacillus acidophilus, Streptococcus thermophilus) twice daily for 12 weeks.
Group B: Placebo capsules for 12 weeks.
Assessments: Baseline, 6 weeks, and 12 weeks – anthropometry, fasting glucose, insulin, HbA1c, lipid profile.
Outcome: HOMA-IR calculation before and after intervention.
Sample Size: 150 (75 per group), based on previous trial data.
Ethics & Safety:
IEC approval and informed consent obtained.
Minimal risk, probiotics considered safe.
Monitoring for adverse events.
Expected Outcomes:
Improved insulin sensitivity (lower HOMA-IR).
Reduction in fasting glucose, insulin, HbA1c, and better lipid profile.
Data to support inclusion of probiotics in prediabetes management.
Budget: Rs.1.22 lakh (self-funded by investigator)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged more than or equal to 18 years.
- •BMI more than or equal 25 (obese as per Asian criteria) or waist circumference more than 102cm in male,more than 88cm in female.
- •Prediabetes (defined as Fasting Blood Glucose 100–125 milligram per decilitre or Post prandial glucose 140-200milligram per decilitre or HbA1c 5.7–6.4.
排除标准
- •1.Patient on steroids, OCP, antibiotic intake (1 week).
- •2.Current or recent (past 3 months) probiotic/prebiotic supplementation.
- •3.Chronic diarhoea.
- •4.Pregnancy or lactation.
- •5.Severe hepatic, renal, or cardiac illness.
结局指标
主要结局
Improvement in insulin sensitivity as measured by HOMA-IR index.
时间窗: fasting insulin level checked at begining of the study ie sample collected at day 0 and at the end of the study ie once the patiet complete 90 days of probiotic course
次要结局
- 1)fasting blood glucose(2)serum insulin level)
研究者
Moulisbabu
pondicherry institute of medical sciences