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

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ClinicalTrials.gov Identifier: NCT03665961
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Genome Institute of Singapore, A*Star
Information provided by (Responsible Party):
John Chen Hsiang, Changi General Hospital

Tracking Information
First Submitted Date September 6, 2018
First Posted Date September 11, 2018
Last Update Posted Date September 11, 2018
Actual Study Start Date October 25, 2016
Actual Primary Completion Date September 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2018)
Association of human gut microbiome profile with central obesity and dietary pattern [ Time Frame: 1 day ]
Species diversity as measured by diversity indices
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 8, 2018)
  • Association of human gut microbiome profile with ethnicity [ Time Frame: 1 day ]
    Species diversity as measured by diversity indices
  • Association of interleukin-6 with central obesity and microbiota [ Time Frame: 1 day ]
    Interleukin-6 concentration in pg/ml
  • Association of tumour necrosis factor - alpha with central obesity and microbiota [ Time Frame: 1 day ]
    Tumour necrosis factor - alpha concentration in pg/ml
  • Association of cleaved cytokeratin 18 with central obesity and microbiota [ Time Frame: 1 day ]
    Cleaved cytokeratin 18 concentration in units/L
  • Association of limulus amebocyte lysate with central obesity and microbiota [ Time Frame: 1 day ]
    Limulus amebocyte lysate concentration in EU/ml
  • Association of lipopolysaccharide binding protein with central obesity and microbiota [ Time Frame: 1 day ]
    Lipopolysaccharide binding protein concentration in ng/ml
  • Analysis of dietary components based on recommended daily allowance [ Time Frame: 3 days ]
    Dietary questionnaire
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Microbial DNA from stool samples, genomic DNA from whole blood, and plasma samples from whole blood
Sampling Method Non-Probability Sample
Study Population Healthy volunteers recruited through advertisement or patients with type 2 diabetes mellitus from hospital records.
Condition Central Obesity
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 8, 2018)
35
Original Actual Enrollment Same as current
Actual Study Completion Date September 26, 2017
Actual Primary Completion Date September 26, 2017   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Singapore
Removed Location Countries  
 
Administrative Information
NCT Number NCT03665961
Other Study ID Numbers MiPOOP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party John Chen Hsiang, Changi General Hospital
Study Sponsor Changi General Hospital
Collaborators Genome Institute of Singapore, A*Star
Investigators
Principal Investigator: John Chen Hsiang, MD, PhD Changi General Hospital
PRS Account Changi General Hospital
Verification Date September 2018