Metabolic Control of Type 2 Diabetes Patients Before and After Dietary Supplementation With the Probiotic Lactobacillus Reuteri DSM 17938 - a Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- HOMA index
研究概览
简要总结
Recent data suggest that the trillions of bacteria in the investigators gastrointestinal tracts (gut microbiota) can function as an environmental factor that modulates the amount of body fat. Obese individuals have an altered gut microbiota and germ-free mice are resistant to developing diet-induced obesity and have lower fasting insulin and glucose and improved glucose tolerance. Administration of the probiotic bacterium Lactobacillus strain in fermented milk for 12 weeks reduced adiposity and body weight in obese adults, possibly by reducing lipid absorption and inflammatory status. However, there are no studies to the investigators knowledge that address whether probiotic supplementation improves glucose metabolism in type 2 diabetes patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes with a duration > 6 months
- •Abdominal obesity
- •HbA1c 50-80 mmol/mol
- •Written informed consent
- •Stated availability throughout the study period
排除标准
- •Autoimmune diabetes eg type 1 diabetes
- •Psychiatric illness or cancer diagnosis
- •No foreseeable need of treatment with corticosteroids or antibiotics
- •Inflammatory bowel disease
- •Administration of antibiotics 4 weeks before inclusion
- •Administration of probiotics 2 weeks before inclusion
- •Participation in other clinical trials
结局指标
主要结局
HOMA index
时间窗: 12 weeks
To determine improved glucose handling and insulin sensitivity in adult type 2 diabetic patients supplemented with the probiotic L. reuteri DSM 17938 over a 12 week period, we assess insulin sensitivity via the HOMA index (fp-Glucose x fS-Insulin divided by 22.5).
次要结局
- Changes in diabetes medication and hypoglycemia events(12 weeks)