The Association Between Microbiota, Endotoxaemia and the Host Obesity/ Insulin Resistance (MiPOOP Study)

Sponsor

Changi General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03665961

Collaborator

Genome Institute of Singapore, A*Star (Other)

Enrollment

Location

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of this study are to examine the effects of ethnicity, central obesity and dietary components, on the human gut microbiome. The investigators hypothesize that these factors have an influence on the composition of the gut microbiome. Healthy subjects (n=35) provided stool samples for gut microbiome profiling using 16S rRNA sequencing and completed a dietary questionnaire. The serum samples were assayed for a panel of inflammatory cytokines. Their associations with central obesity were examined.

Condition or Disease	Intervention/Treatment	Phase
Central Obesity

Detailed Description

Introduction: Perturbance in the composition of human gut microbiota has been associated with metabolic disorders such as obesity, diabetes mellitus and insulin resistance. The objectives of this study are to examine the effects of ethnicity, central obesity and dietary components, on the human gut microbiome. The investigators hypothesize that these factors have an influence on the composition of the gut microbiome.

Methods: Subjects of Chinese (n=14), Malay (n=10) or Indian (n=11) ancestry, median age 39 (range:22-70 years old), were enrolled. The subjects provided stool samples for gut microbiome profiling using 16S rRNA sequencing and completed a dietary questionnaire. The serum samples were assayed for a panel of biomarkers (Interleukin-6, tumour necrosis factor alpha, adiponectin, cleaved cytokeratin 18, lipopolysaccharide binding protein and limulus amebocyte lysate). Central obesity was defined by waist circumference cut-offs in Asians.

Study Design

Study Type:

Observational

Actual Enrollment :

35 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

The Association Between Microbiota, Endotoxaemia and the Host Obesity/ Insulin Resistance (MiPOOP Study)

Actual Study Start Date :

Oct 25, 2016

Actual Primary Completion Date :

Sep 26, 2017

Actual Study Completion Date :

Sep 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Central obesity Cases with central obesity as defined by waist circumference cut-offs ≥ 90 cm in men and ≥ 80 cm in women for Asians
No central obesity Controls with no central obesity

Outcome Measures

Primary Outcome Measures

Association of human gut microbiome profile with central obesity and dietary pattern [1 day]
Species diversity as measured by diversity indices

Secondary Outcome Measures

Association of human gut microbiome profile with ethnicity [1 day]
Species diversity as measured by diversity indices
Association of interleukin-6 with central obesity and microbiota [1 day]
Interleukin-6 concentration in pg/ml
Association of tumour necrosis factor - alpha with central obesity and microbiota [1 day]
Tumour necrosis factor - alpha concentration in pg/ml
Association of cleaved cytokeratin 18 with central obesity and microbiota [1 day]
Cleaved cytokeratin 18 concentration in units/L
Association of limulus amebocyte lysate with central obesity and microbiota [1 day]
Limulus amebocyte lysate concentration in EU/ml
Association of lipopolysaccharide binding protein with central obesity and microbiota [1 day]
Lipopolysaccharide binding protein concentration in ng/ml
Analysis of dietary components based on recommended daily allowance [3 days]
Dietary questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 75 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Provision of signed written informed consent,
Aged between 21- 75 years old,
Body Mass Index (BMI) of > 18 kg/m2,
Ethnic group of either Chinese, Malay or Indian as evidenced by identification card,
Subject with absence of impaired glucose tolerance,
Subject is healthy with no clinically significant disease or condition as determined through their medical history, physical examination; Diabetes mellitus was defined as Type 2 DM fulfilling the WHO criteria and the care of Department of Endocrinology, Changi General Hospital,
Ability to communicate with investigator and to understand and comply with all requirements of study participation.

Exclusion Criteria:

Subject who are viral Hepatitis (B or C) or HIV positive as per declaration,
Subject who had bariatric surgery including lap banding, gastric sleeve surgery, cholecystectomy,
Subject who has > 5% weight loss in the last 3 months prior to study enrolment as per declaration,
Subject who are on 'stable' insulin sensitizers such as such as rosiglitazone, metformin for the last 3 months prior to enrolment,
Pregnant women,
Subject who has been treated with antibiotics within 6 weeks of enrolment,
Subject who has usage of lactulose, dietary fibres for purpose of constipation,
Subject with immune-compromised status; undergoing chemotherapy, on steroid,
Subject with FMHx or PMHx of autoimmune disease, GI cancers, inflammatory bowel disease, Irritable bowel syndrome and anxiety or depression as per declaration.