Central ObesityMiPOOPNCT03665961
The Association Between Microbiota, Endotoxaemia and the Host Obesity/ Insulin Resistance (MiPOOP Study)
An observational study of Central Obesity, run by Changi General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Central Obesity
- How many people
- 35 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Oct 2016to 26 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Adult, Older adult
Study population: Healthy volunteers recruited through advertisement or patients with type 2 diabetes mellitus from hospital records.
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Central Obesity
- Keywords
- gastrointestinal microbiome, metabolic syndrome, ethnicity, dietary components
- Medical subject headings
- Obesity, Abdominal, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of human gut microbiome profile with central obesity and dietary pattern
Species diversity as measured by diversity indices
Measured: 1 day
Secondary outcomes (7)
Association of human gut microbiome profile with ethnicity
Species diversity as measured by diversity indices
Measured: 1 day
Association of interleukin-6 with central obesity and microbiota
Interleukin-6 concentration in pg/ml
Measured: 1 day
Association of tumour necrosis factor - alpha with central obesity and microbiota
Tumour necrosis factor - alpha concentration in pg/ml
Measured: 1 day
Association of cleaved cytokeratin 18 with central obesity and microbiota
Cleaved cytokeratin 18 concentration in units/L
Measured: 1 day
Association of limulus amebocyte lysate with central obesity and microbiota
Limulus amebocyte lysate concentration in EU/ml
Measured: 1 day
Association of lipopolysaccharide binding protein with central obesity and microbiota
Lipopolysaccharide binding protein concentration in ng/ml
Measured: 1 day
Analysis of dietary components based on recommended daily allowance
Dietary questionnaire
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start25 Oct 2016
- Primary completion26 Sep 2017
- Study completion26 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Central ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Genome Institute of Singapore
- Responsible party
- Principal investigator, John Chen Hsiang, Changi General Hospital
- Investigators
- John Chen Hsiang, MD, PhD, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665961
- Sponsor's protocol ID
- MiPOOP
- Acronym
- MiPOOP
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25371019Ho 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.
PubMed 30089174
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Microbiota, Endotoxaemia and the Host Obesity/ Insulin Resistance (MiPOOP Study)
- ClinicalTrials.gov ID
- NCT03665961
- Acronym / sponsor ID
- MiPOOP / MiPOOP
- Conditions
- Central Obesity
- Keywords
- gastrointestinal microbiome, metabolic syndrome, ethnicity, dietary components
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- Genome Institute of Singapore
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 26 Sep 2017 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers recruited through advertisement or patients with type 2 diabetes mellitus from hospital records.
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of human gut microbiome profile with central obesity and dietary pattern
Time frame: 1 day
Species diversity as measured by diversity indices
7 secondary outcomes
Association of human gut microbiome profile with ethnicity
Time frame: 1 day
Association of interleukin-6 with central obesity and microbiota
Time frame: 1 day
Association of tumour necrosis factor - alpha with central obesity and microbiota
Time frame: 1 day
Association of cleaved cytokeratin 18 with central obesity and microbiota
Time frame: 1 day
Association of limulus amebocyte lysate with central obesity and microbiota
Time frame: 1 day
Association of lipopolysaccharide binding protein with central obesity and microbiota
Time frame: 1 day
Analysis of dietary components based on recommended daily allowance
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Background: PubMed 25371019Hsiang 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.
- Background: PubMed 30089174Ho 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Chen Hsiang, MD, PhD principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Obesity, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of human gut microbiome profile with central obesity and dietary pattern (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665961, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.