Gut Microbiomes in Patients With Metabolic Syndrome

NCT03489317 | Unknown

• 1 other identifier: 2017.514
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Metabolic Syndrome

Keywords

gut microbiome; stool

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

No metabolic syndrome

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

Metabolic syndrome- partial

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

Drug: Metformin; Behavioral: lifestyle modification; Drug: Simvastatin 10mg; Drug: Amlodipine 5mg

Metabolic syndrome- full

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

Drug: Metformin; Behavioral: lifestyle modification; Drug: Simvastatin 10mg; Drug: Amlodipine 5mg

Interventions

Metformin 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.

Metabolic syndrome- full; Metabolic syndrome- partial

lifestyle modification 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.

Metabolic syndrome- full; Metabolic syndrome- partial

Simvastatin 10mg 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.

Metabolic syndrome- full; Metabolic syndrome- partial

Amlodipine 5mg 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; Metabolic syndrome- partial

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Resident of Hong Kong

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Department of Microbiology, Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

Lek Yuen Health Centre

Shatin, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stools, whole blood, urine

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Metformin; Simvastatin; Amlodipine

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yun Kit Yeoh

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Kit Yeoh

CONTACT

85235053333; yeohyunkit@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 5, 2018
• Study Start: November 27, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 23, 2018

Record last verified: 2018-07

Locations

HK (2)