Gut Microbiomes in Patients With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Gut Microbiomes and Viromes in Patients With Metabolic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03489317
• Other study ID #: 2017.514
• Status: Recruiting
• Start date: November 27, 2017
• Est. completion date: December 2021

Study information

• Verified date: July 2018
• Source: Chinese University of Hong Kong
• Contact: Yun Kit Yeoh
• Phone: 85235053333
• Email: yeohyunkit[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• 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.

Behavioral:
• 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.

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Hong Kong	Department of Microbiology, Chinese University of Hong Kong	Sha Tin
Hong Kong	Lek Yuen Health Centre	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in waist circumference at four weeks	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.	four weeks in participants receiving drug intervention for metabolic syndrome
Primary	Change in baseline systolic and diastolic blood pressure at four weeks	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.	four weeks in participants receiving drug intervention for metabolic syndrome
Primary	Change in blood triglyceride levels at four weeks	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.	four weeks in participants receiving drug intervention for metabolic syndrome
Primary	Change in high-density lipoprotein (HDL) cholesterol levels at four weeks	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.	four weeks in participants receiving drug intervention for metabolic syndrome
Primary	Change in fasting blood sugar levels at four weeks	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.	four weeks in participants receiving drug intervention for metabolic syndrome
Primary	Change in waist circumference at six months	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.	six months in all participants with metabolic syndrome
Primary	Change in baseline systolic and diastolic blood pressure at six months	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.	six months in all participants with metabolic syndrome
Primary	Change in blood triglyceride levels at six months	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.	six months in all participants with metabolic syndrome
Primary	Change in high-density lipoprotein (HDL) cholesterol levels at six months	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.	six months in all participants with metabolic syndrome
Primary	Change in fasting blood sugar levels at six months	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.	six months in all participants with metabolic syndrome