Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03665961
Acronym
MiPOOP
Enrollment
35
Registered
2018-09-11
Start date
2016-10-25
Completion date
2017-09-26
Last updated
2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Obesity

Keywords

gastrointestinal microbiome, metabolic syndrome, ethnicity, dietary components

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.

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.

Interventions

None listed

Sponsors

Genome Institute of Singapore
CollaboratorOTHER
Changi General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Association of human gut microbiome profile with central obesity and dietary pattern1 daySpecies diversity as measured by diversity indices

Secondary

MeasureTime frameDescription
Association of human gut microbiome profile with ethnicity1 daySpecies diversity as measured by diversity indices
Association of interleukin-6 with central obesity and microbiota1 dayInterleukin-6 concentration in pg/ml
Association of tumour necrosis factor - alpha with central obesity and microbiota1 dayTumour necrosis factor - alpha concentration in pg/ml
Association of cleaved cytokeratin 18 with central obesity and microbiota1 dayCleaved cytokeratin 18 concentration in units/L
Association of limulus amebocyte lysate with central obesity and microbiota1 dayLimulus amebocyte lysate concentration in EU/ml
Association of lipopolysaccharide binding protein with central obesity and microbiota1 dayLipopolysaccharide binding protein concentration in ng/ml
Analysis of dietary components based on recommended daily allowance3 daysDietary questionnaire

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026