Clinical trial NCT03665961: The Association Between Microbiota, Endotoxaemia and the Host Obesity/ Insulin Resistance (MiPOOP Study)
Official title: The Association Between Microbiota, Endotoxaemia and the Host Obesity/ Insulin Resistance (MiPOOP Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Obesity
Keywords: gastrointestinal microbiome
metabolic syndrome
ethnicity
dietary components
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
Collaborators: name: Genome Institute of Singapore
First posted: 2018-09-11
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers recruited through advertisement or patients with type 2 diabetes mellitus from hospital records.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Association of human gut microbiome profile with central obesity and dietary pattern
timeFrame: 1 day
Secondary outcomes:
measure: Association of human gut microbiome profile with ethnicity
timeFrame: 1 day
measure: Association of interleukin-6 with central obesity and microbiota
timeFrame: 1 day
measure: Association of tumour necrosis factor - alpha with central obesity and microbiota
timeFrame: 1 day
measure: Association of cleaved cytokeratin 18 with central obesity and microbiota
timeFrame: 1 day
measure: Association of limulus amebocyte lysate with central obesity and microbiota
timeFrame: 1 day
measure: Association of lipopolysaccharide binding protein with central obesity and microbiota
timeFrame: 1 day
measure: Analysis of dietary components based on recommended daily allowance
timeFrame: 3 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: John Chen Hsiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsiang JC, Bai WW, Raos Z, Stableforth W, Upton A, Selvaratnam S, Gane EJ, Gerred SJ. Epidemiology, disease burden and outcomes of cirrhosis in a large secondary care hospital in South Auckland, New Zealand. Intern Med J. 2015 Feb;45(2):160-9. doi: 10.1111/imj.12624.
citation: Ho EXP, Cheung CMG, Sim S, Chu CW, Wilm A, Lin CB, Mathur R, Wong D, Chan CM, Bhagarva M, Laude A, Lim TH, Wong TY, Cheng CY, Davila S, Hibberd M. Human pharyngeal microbiota in age-related macular degeneration. PLoS One. 2018 Aug 8;13(8):e0201768. doi: 10.1371/journal.pone.0201768. eCollection 2018.