Ignite Creation Date:
2025-12-24 @ 12:33 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT03665961
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2018-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between Microbiota, Endotoxaemia and the Host Obesity/ Insulin Resistance (MiPOOP Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Microbial DNA from stool samples, genomic DNA from whole blood, and plasma samples from whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-08', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-08', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association of human gut microbiome profile with central obesity and dietary pattern', 'timeFrame': '1 day', 'description': 'Species diversity as measured by diversity indices'}], 'secondaryOutcomes': [{'measure': 'Association of human gut microbiome profile with ethnicity', 'timeFrame': '1 day', 'description': 'Species diversity as measured by diversity indices'}, {'measure': 'Association of interleukin-6 with central obesity and microbiota', 'timeFrame': '1 day', 'description': 'Interleukin-6 concentration in pg/ml'}, {'measure': 'Association of tumour necrosis factor - alpha with central obesity and microbiota', 'timeFrame': '1 day', 'description': 'Tumour necrosis factor - alpha concentration in pg/ml'}, {'measure': 'Association of cleaved cytokeratin 18 with central obesity and microbiota', 'timeFrame': '1 day', 'description': 'Cleaved cytokeratin 18 concentration in units/L'}, {'measure': 'Association of limulus amebocyte lysate with central obesity and microbiota', 'timeFrame': '1 day', 'description': 'Limulus amebocyte lysate concentration in EU/ml'}, {'measure': 'Association of lipopolysaccharide binding protein with central obesity and microbiota', 'timeFrame': '1 day', 'description': 'Lipopolysaccharide binding protein concentration in ng/ml'}, {'measure': 'Analysis of dietary components based on recommended daily allowance', 'timeFrame': '3 days', 'description': 'Dietary questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastrointestinal microbiome', 'metabolic syndrome', 'ethnicity', 'dietary components'], 'conditions': ['Central Obesity']}, 'referencesModule': {'references': [{'pmid': '25371019', 'type': 'BACKGROUND', '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.'}, {'pmid': '30089174', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMethods: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers recruited through advertisement or patients with type 2 diabetes mellitus from hospital records.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of signed written informed consent,\n* Aged between 21- 75 years old,\n* Body Mass Index (BMI) of \\> 18 kg/m2,\n* Ethnic group of either Chinese, Malay or Indian as evidenced by identification card,\n* Subject with absence of impaired glucose tolerance,\n* 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,\n* Ability to communicate with investigator and to understand and comply with all requirements of study participation.\n\nExclusion Criteria:\n\n* Subject who are viral Hepatitis (B or C) or HIV positive as per declaration,\n* Subject who had bariatric surgery including lap banding, gastric sleeve surgery, cholecystectomy,\n* Subject who has \\> 5% weight loss in the last 3 months prior to study enrolment as per declaration,\n* Subject who are on 'stable' insulin sensitizers such as such as rosiglitazone, metformin for the last 3 months prior to enrolment,\n* Pregnant women,\n* Subject who has been treated with antibiotics within 6 weeks of enrolment,\n* Subject who has usage of lactulose, dietary fibres for purpose of constipation,\n* Subject with immune-compromised status; undergoing chemotherapy, on steroid,\n* Subject with FMHx or PMHx of autoimmune disease, GI cancers, inflammatory bowel disease, Irritable bowel syndrome and anxiety or depression as per declaration."}, 'identificationModule': {'nctId': 'NCT03665961', 'acronym': 'MiPOOP', 'briefTitle': 'The Association Between Microbiota, Endotoxaemia and the Host Obesity/ Insulin Resistance (MiPOOP Study)', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'The Association Between Microbiota, Endotoxaemia and the Host Obesity/ Insulin Resistance (MiPOOP Study)', 'orgStudyIdInfo': {'id': 'MiPOOP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Central obesity', 'description': 'Cases with central obesity as defined by waist circumference cut-offs ≥ 90 cm in men and ≥ 80 cm in women for Asians'}, {'label': 'No central obesity', 'description': 'Controls with no central obesity'}]}, 'contactsLocationsModule': {'locations': [{'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'John Chen Hsiang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changi General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genome Institute of Singapore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'John Chen Hsiang', 'investigatorAffiliation': 'Changi General Hospital'}}}}