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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

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
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.


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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 : October 25, 2016
Actual Primary Completion Date : September 26, 2017
Actual Study Completion Date : September 26, 2017

Group/Cohort
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



Primary Outcome Measures :
  1. Association of human gut microbiome profile with central obesity and dietary pattern [ Time Frame: 1 day ]
    Species diversity as measured by diversity indices


Secondary Outcome Measures :
  1. Association of human gut microbiome profile with ethnicity [ Time Frame: 1 day ]
    Species diversity as measured by diversity indices

  2. Association of interleukin-6 with central obesity and microbiota [ Time Frame: 1 day ]
    Interleukin-6 concentration in pg/ml

  3. Association of tumour necrosis factor - alpha with central obesity and microbiota [ Time Frame: 1 day ]
    Tumour necrosis factor - alpha concentration in pg/ml

  4. Association of cleaved cytokeratin 18 with central obesity and microbiota [ Time Frame: 1 day ]
    Cleaved cytokeratin 18 concentration in units/L

  5. Association of limulus amebocyte lysate with central obesity and microbiota [ Time Frame: 1 day ]
    Limulus amebocyte lysate concentration in EU/ml

  6. Association of lipopolysaccharide binding protein with central obesity and microbiota [ Time Frame: 1 day ]
    Lipopolysaccharide binding protein concentration in ng/ml

  7. Analysis of dietary components based on recommended daily allowance [ Time Frame: 3 days ]
    Dietary questionnaire


Biospecimen Retention:   Samples With DNA
Microbial DNA from stool samples, genomic DNA from whole blood, and plasma samples from whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers recruited through advertisement or patients with type 2 diabetes mellitus from hospital records.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665961


Locations
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Singapore
Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Changi General Hospital
Genome Institute of Singapore, A*Star
Investigators
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Principal Investigator: John Chen Hsiang, MD, PhD Changi General Hospital

Publications:
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Responsible Party: John Chen Hsiang, Consultant, Changi General Hospital
ClinicalTrials.gov Identifier: NCT03665961     History of Changes
Other Study ID Numbers: MiPOOP
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John Chen Hsiang, Changi General Hospital:
gastrointestinal microbiome
metabolic syndrome
ethnicity
dietary components

Additional relevant MeSH terms:
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Endotoxemia
Obesity
Insulin Resistance
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs