Gut Microbiomes and Viromes in Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Change in waist circumference at four weeks
研究概览
简要总结
Metabolic syndrome (MS) is defined by a manifestation of cardiometabolic risk factors including high blood pressure, glucose and triglycerides, low high-density lipoprotein (HDL) cholesterol, and abdominal obesity. It is closely associated with other diseases such as fatty liver and gouty arthritis. In recent years there is evidence that gut microorganisms are intimately linked to health and wellbeing. Here, the investigators hypothesize that gut microorganisms are involved in the regulation and/or onset of MS and its symptoms.
详细描述
There is mounting evidence that the gut microbiome plays a vital role in health and wellbeing. In particular, population-association and mouse model studies have demonstrated that gut bacteria can be reproducibly linked to obesity and diabetes. There is, however, a lack of progress in translating current scientific knowledge to healthcare practices in part due to the strong influence of biogeography and demography on gut microbiomes. Another major knowledge gap in gut microbiomes is the ecology of gut viruses and their associations with MS despite having intimate relationships with human and bacterial hosts.
In this study, the investigators aim to assess variation in the gut microbiomes of patients with MS with reference to the healthy population in Hong Kong, and to explore gut microorganisms as predictive/diagnostic markers of MS and clinical outcomes associated with medical interventions. This will be achieved through studying microorganisms in the stools of participants. The investigators will use the 16S small subunit ribosomal RNA (16S rRNA) marker gene to create compositional profiles of the gut microbial community in healthy and individuals with MS to identify bacterial populations that are associated with the onset and progression of MS. A subset of samples will be selected for bulk DNA sequencing based on their stool community profiles and/or MS parameters to obtain genomic information of the microorganisms involved.
Participants who undergo intervention as part of their routine medical care for MS will be invited to provide stool samples following intervention. These stools will be used to profile gut microbial communities to investigate whether their compositions undergo changes reflective of medical intervention. Here, the aim is to investigate whether resolution of MS symptoms can be linked to alterations in gut microorganisms, and the hypothesis is that their profiles will more closely resemble healthy individuals following medical intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resident of Hong Kong
排除标准
- •Major organ system impairment such as heart failure, renal failure, and severe impairment of respiratory function.
- •On long-term regular immunosuppressive therapy
- •Current or history of malignancy
- •Current or history of major gastrointestinal diseases, including inflammatory bowel disease, major gastrointestinal surgery
- •On medication for glucose or lipid control, such as metformin and statin
研究组 & 干预措施
Metabolic syndrome- partial
Participants who fulfill one or two of the five criteria for metabolic syndrome defined by the International Diabetes Federation.
干预措施: Metformin (Drug)
Metabolic syndrome- partial
Participants who fulfill one or two of the five criteria for metabolic syndrome defined by the International Diabetes Federation.
干预措施: lifestyle modification (Behavioral)
Metabolic syndrome- partial
Participants who fulfill one or two of the five criteria for metabolic syndrome defined by the International Diabetes Federation.
干预措施: Simvastatin 10mg (Drug)
Metabolic syndrome- partial
Participants who fulfill one or two of the five criteria for metabolic syndrome defined by the International Diabetes Federation.
干预措施: Amlodipine 5mg (Drug)
Metabolic syndrome- full
Participants who fulfill three or more of the five criteria for metabolic syndrome defined by the International Diabetes Federation.
干预措施: Metformin (Drug)
Metabolic syndrome- full
Participants who fulfill three or more of the five criteria for metabolic syndrome defined by the International Diabetes Federation.
干预措施: lifestyle modification (Behavioral)
Metabolic syndrome- full
Participants who fulfill three or more of the five criteria for metabolic syndrome defined by the International Diabetes Federation.
干预措施: Simvastatin 10mg (Drug)
Metabolic syndrome- full
Participants who fulfill three or more of the five criteria for metabolic syndrome defined by the International Diabetes Federation.
干预措施: Amlodipine 5mg (Drug)
结局指标
主要结局
Change in waist circumference at four weeks
时间窗: four weeks in participants receiving drug intervention for metabolic syndrome
Waist circumference is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a circumference of ≥90 cm (male) or ≥80 cm (female) is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether any changes in waist circumference can be associated with gut microorganisms.
Change in baseline systolic and diastolic blood pressure at four weeks
时间窗: four weeks in participants receiving drug intervention for metabolic syndrome
Blood pressure is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a blood pressure reading of ≥130/85 mm Hg (systolic/diastolic pressure) is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether any changes in baseline systolic and diastolic blood pressure can be associated with gut microorganisms.
Change in fasting blood sugar levels at four weeks
时间窗: four weeks in participants receiving drug intervention for metabolic syndrome
Fasting blood sugar levels is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a fasting blood sugar level of ≥5.6 mmol/L is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether fasting blood sugar levels can be associated with gut microorganisms.
Change in blood triglyceride levels at four weeks
时间窗: four weeks in participants receiving drug intervention for metabolic syndrome
Blood triglyceride concentration is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a triglyceride level of ≥1.7 mmol/L is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether any changes in blood triglyceride levels can be associated with gut microorganisms.
Change in fasting blood sugar levels at six months
时间窗: six months in all participants with metabolic syndrome
Fasting blood sugar levels is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a fasting blood sugar level of ≥5.6 mmol/L is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether fasting blood sugar levels can be associated with gut microorganisms.
Change in waist circumference at six months
时间窗: six months in all participants with metabolic syndrome
Waist circumference is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a circumference of ≥90 cm (male) or ≥80 cm (female) is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether any changes in waist circumference can be associated with gut microorganisms.
Change in high-density lipoprotein (HDL) cholesterol levels at six months
时间窗: six months in all participants with metabolic syndrome
High-density lipoprotein (HDL) cholesterol levels is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a HDL cholesterol level of \<1.03 mmol/L (males) or \<1.29 mmol/L (females) is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether HDL cholesterol levels can be associated with gut microorganisms.
Change in high-density lipoprotein (HDL) cholesterol levels at four weeks
时间窗: four weeks in participants receiving drug intervention for metabolic syndrome
High-density lipoprotein (HDL) cholesterol levels is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a HDL cholesterol level of \<1.03 mmol/L (males) or \<1.29 mmol/L (females) is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether HDL cholesterol levels can be associated with gut microorganisms.
Change in baseline systolic and diastolic blood pressure at six months
时间窗: six months in all participants with metabolic syndrome
Blood pressure is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a blood pressure reading of ≥130/85 mm Hg (systolic/diastolic pressure) is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether any changes in baseline systolic and diastolic blood pressure can be associated with gut microorganisms.
Change in blood triglyceride levels at six months
时间窗: six months in all participants with metabolic syndrome
Blood triglyceride concentration is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a triglyceride level of ≥1.7 mmol/L is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether any changes in blood triglyceride levels can be associated with gut microorganisms.
次要结局
未报告次要终点
研究者
Yeoh Yun Kit
Research Assistant Professor
Chinese University of Hong Kong