Gut Microbiomes in Patients With Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-27

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metabolic Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No metabolic syndrome

Participants who do not fulfill any of the five criteria for metabolic syndrome defined by the International Diabetes Federation.

No interventions assigned to this group

Metabolic syndrome- partial

Participants who fulfill one or two of the five criteria for metabolic syndrome defined by the International Diabetes Federation.

Metformin

Intervention Type DRUG

Participants with high glucose levels will usually be prescribed Metformin 250 mg three times daily. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.

lifestyle modification

Intervention Type BEHAVIORAL

Participants with metabolic syndrome will be offered advice on modifying their diets and exercise regimes. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.

Simvastatin 10mg

Intervention Type DRUG

Participants with elevated lipid levels will usually be prescribed simvastatin 10 mg at night. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.

Amlodipine 5mg

Intervention Type DRUG

Participants with high blood pressure could be prescribed antihypertensive medicine such as Amlodipine. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.

Metabolic syndrome- full

Participants who fulfill three or more of the five criteria for metabolic syndrome defined by the International Diabetes Federation.

Metformin

Intervention Type DRUG

Participants with high glucose levels will usually be prescribed Metformin 250 mg three times daily. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.

lifestyle modification

Intervention Type BEHAVIORAL

Participants with metabolic syndrome will be offered advice on modifying their diets and exercise regimes. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.

Simvastatin 10mg

Intervention Type DRUG

Participants with elevated lipid levels will usually be prescribed simvastatin 10 mg at night. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.

Amlodipine 5mg

Intervention Type DRUG

Participants with high blood pressure could be prescribed antihypertensive medicine such as Amlodipine. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.

Interventions

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Metformin

Participants with high glucose levels will usually be prescribed Metformin 250 mg three times daily. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.

Intervention Type DRUG

lifestyle modification

Participants with metabolic syndrome will be offered advice on modifying their diets and exercise regimes. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.

Intervention Type BEHAVIORAL

Simvastatin 10mg

Participants with elevated lipid levels will usually be prescribed simvastatin 10 mg at night. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.

Intervention Type DRUG

Amlodipine 5mg

Participants with high blood pressure could be prescribed antihypertensive medicine such as Amlodipine. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes