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

NCT03665961 | Completed

• 1 other identifier: MiPOOP
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Obesity

Keywords

gastrointestinal microbiome; metabolic syndrome; ethnicity; dietary components

Outcome Measures

Primary Outcomes (1)

• Association of human gut microbiome profile with central obesity and dietary pattern

  Species diversity as measured by diversity indices

  1 day

Secondary Outcomes (7)

• Association of human gut microbiome profile with ethnicity

  1 day

• Association of interleukin-6 with central obesity and microbiota

  1 day

• Association of tumour necrosis factor - alpha with central obesity and microbiota

  1 day

• Association of cleaved cytokeratin 18 with central obesity and microbiota

  1 day

• Association of limulus amebocyte lysate with central obesity and microbiota

  1 day

Study Arms (2)

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

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers recruited through advertisement or patients with type 2 diabetes mellitus from hospital records.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changi General Hospital: lead
• Genome Institute of Singapore: collaborator

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (2)

• 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.

  PMID: 25371019 BACKGROUND

• 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.

  PMID: 30089174 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Microbial DNA from stool samples, genomic DNA from whole blood, and plasma samples from whole blood

MeSH Terms

Conditions

Obesity, Abdominal; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• John Chen Hsiang, MD, PhD

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 11, 2018
• Study Start: October 25, 2016
• Primary Completion: September 26, 2017
• Study Completion: September 26, 2017
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)