The Association Between Microbiota, Endotoxaemia and the Host Obesity/ Insulin Resistance (MiPOOP Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Association of human gut microbiome profile with central obesity and dietary pattern
研究概览
简要总结
The objectives of this study are to examine the effects of ethnicity, central obesity and dietary components, on the human gut microbiome. The investigators hypothesize that these factors have an influence on the composition of the gut microbiome. Healthy subjects (n=35) provided stool samples for gut microbiome profiling using 16S rRNA sequencing and completed a dietary questionnaire. The serum samples were assayed for a panel of inflammatory cytokines. Their associations with central obesity were examined.
详细描述
Introduction
Perturbance in the composition of human gut microbiota has been associated with metabolic disorders such as obesity, diabetes mellitus and insulin resistance. The objectives of this study are to examine the effects of ethnicity, central obesity and dietary components, on the human gut microbiome. The investigators hypothesize that these factors have an influence on the composition of the gut microbiome.
Methods: Subjects of Chinese (n=14), Malay (n=10) or Indian (n=11) ancestry, median age 39 (range:22-70 years old), were enrolled. The subjects provided stool samples for gut microbiome profiling using 16S rRNA sequencing and completed a dietary questionnaire. The serum samples were assayed for a panel of biomarkers (Interleukin-6, tumour necrosis factor alpha, adiponectin, cleaved cytokeratin 18, lipopolysaccharide binding protein and limulus amebocyte lysate). Central obesity was defined by waist circumference cut-offs in Asians.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed written informed consent,
- •Aged between 21- 75 years old,
- •Body Mass Index (BMI) of > 18 kg/m2,
- •Ethnic group of either Chinese, Malay or Indian as evidenced by identification card,
- •Subject with absence of impaired glucose tolerance,
- •Subject is healthy with no clinically significant disease or condition as determined through their medical history, physical examination; Diabetes mellitus was defined as Type 2 DM fulfilling the WHO criteria and the care of Department of Endocrinology, Changi General Hospital,
- •Ability to communicate with investigator and to understand and comply with all requirements of study participation.
排除标准
- •Subject who are viral Hepatitis (B or C) or HIV positive as per declaration,
- •Subject who had bariatric surgery including lap banding, gastric sleeve surgery, cholecystectomy,
- •Subject who has > 5% weight loss in the last 3 months prior to study enrolment as per declaration,
- •Subject who are on 'stable' insulin sensitizers such as such as rosiglitazone, metformin for the last 3 months prior to enrolment,
- •Pregnant women,
- •Subject who has been treated with antibiotics within 6 weeks of enrolment,
- •Subject who has usage of lactulose, dietary fibres for purpose of constipation,
- •Subject with immune-compromised status; undergoing chemotherapy, on steroid,
- •Subject with FMHx or PMHx of autoimmune disease, GI cancers, inflammatory bowel disease, Irritable bowel syndrome and anxiety or depression as per declaration.
结局指标
主要结局
Association of human gut microbiome profile with central obesity and dietary pattern
时间窗: 1 day
Species diversity as measured by diversity indices
次要结局
- Association of human gut microbiome profile with ethnicity(1 day)
- Association of cleaved cytokeratin 18 with central obesity and microbiota(1 day)
- Association of lipopolysaccharide binding protein with central obesity and microbiota(1 day)
- Association of tumour necrosis factor - alpha with central obesity and microbiota(1 day)
- Association of interleukin-6 with central obesity and microbiota(1 day)
- Association of limulus amebocyte lysate with central obesity and microbiota(1 day)
- Analysis of dietary components based on recommended daily allowance(3 days)
研究者
John Chen Hsiang
Consultant
Changi General Hospital