Clinical trial NCT03489317: Gut Microbiomes in Patients With Metabolic Syndrome
Official title: Gut Microbiomes and Viromes in Patients With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Keywords: gut microbiome
stool
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Hong Kong will be invited from health talks, blogs, notices and advertisement through various public media channels, as well as patients referred to the Lek Yuen Health Centre, a university teaching clinic, for suspected or confirmed metabolic syndrome.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Resident of Hong Kong

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in waist circumference at four weeks
timeFrame: four weeks in participants receiving drug intervention for metabolic syndrome
measure: Change in baseline systolic and diastolic blood pressure at four weeks
timeFrame: four weeks in participants receiving drug intervention for metabolic syndrome
measure: Change in blood triglyceride levels at four weeks
timeFrame: four weeks in participants receiving drug intervention for metabolic syndrome
measure: Change in high-density lipoprotein (HDL) cholesterol levels at four weeks
timeFrame: four weeks in participants receiving drug intervention for metabolic syndrome
measure: Change in fasting blood sugar levels at four weeks
timeFrame: four weeks in participants receiving drug intervention for metabolic syndrome
measure: Change in waist circumference at six months
timeFrame: six months in all participants with metabolic syndrome
measure: Change in baseline systolic and diastolic blood pressure at six months
timeFrame: six months in all participants with metabolic syndrome
measure: Change in blood triglyceride levels at six months
timeFrame: six months in all participants with metabolic syndrome
measure: Change in high-density lipoprotein (HDL) cholesterol levels at six months
timeFrame: six months in all participants with metabolic syndrome
measure: Change in fasting blood sugar levels at six months
timeFrame: six months in all participants with metabolic syndrome
Secondary outcomes:
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Department of Microbiology, Chinese University of Hong Kong
city: Sha Tin
country: Hong Kong
facility: Lek Yuen Health Centre
Study officials:
affiliation: Chinese University of Hong Kong
name: Yun Kit Yeoh
role: PRINCIPAL_INVESTIGATOR
References: