Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-01-04 @ 8:33 AM
Study NCT ID:
NCT02124759
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2014-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069603', 'term': 'Sevelamer'}, {'id': 'D058616', 'term': 'Synbiotics'}, {'id': 'C008315', 'term': 'maltodextrin'}, {'id': 'D059305', 'term': 'Diet, High-Fat'}, {'id': 'D018752', 'term': 'Diet, Fat-Restricted'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D056692', 'term': 'Prebiotics'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'musi@uthscsa.edu', 'phone': '630-5001', 'title': 'Dr. Nicolas Musi', 'phoneExt': '210', 'organization': 'UTHSC San Antonio'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Despite continued recruitment efforts, we had difficulty with subjects fully completing the study due to dissatisfaction with the diets. Evaluable subjects completed both low and high fat diet while randomized to one of the three interventions, and only insulin sensitivity was captured for both the low fat and high fat diets due to the low completion numbers.'}}, 'adverseEventsModule': {'timeFrame': "Adverse Event Data was collected over the course of the study intervention period, beginning with subject's enrollment into study and ending once they completed all visits. This period takes approximately 6 months from screening to completion of all visits.", 'description': 'Adverse events were collected per arm of the study, for placebo, sevelamer and synbiotic, rather than by arm and low or high fat diet. Each arm reports adverse events to include the participant assignment to either low or high fat diets.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Maltodextrin: This is a control group that were fed both low and high fat diets.\n\nMaltodextrin, 6 g three times a day', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sevelamer', 'description': 'Sevelamer: 1.6 g sevelamer + 4.4 g maltodextrin three times a day that were fed either a low fat or high fat diet, followed by the other type of diet.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Synbiotic', 'description': 'Synbiotic: 5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day that were fed either a low fat or high fat diet, followed by the other type of diet.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'notes': 'Hematoma at muscle biopsy site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mouth Ulcers', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Bloating/Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasovagal Syncope', 'notes': 'Syncope during medical procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gum Infection', 'notes': 'Treated with Abx and removed off protocol', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Sensitivity Low Fat Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo, maltodextrin, 6 g three times a day'}, {'id': 'OG001', 'title': 'Sevelamer', 'description': 'Sevelamer: 1.6 g sevelamer + 4.4 g maltodextrin three times a day'}, {'id': 'OG002', 'title': 'Synbiotic', 'description': '\\*synbiotic \\[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion CFU/g)three times a day\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '0', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Skeletal muscle insulin sensitivity measured after 28 days of low fat diet and drug intervention. The isocaloric low fat diet will provide 55% energy from carbohydrates, 20% from fat and 25% from protein.', 'unitOfMeasure': 'M value (mg/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Insulin Sensitivity High Fat Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Maltodextrin: This is a control group. Maltodextrin, 6 g three times a day'}, {'id': 'OG001', 'title': 'Sevelamer', 'description': 'Sevelamer: 1.6 g sevelamer + 4.4 g maltodextrin three times a day'}, {'id': 'OG002', 'title': 'Synbiotic', 'description': 'Synbiotic: 5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '0', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '1.87', 'groupId': 'OG001'}, {'value': '8.8', 'spread': '1.63', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Null hypothesis is that high fat diet will have no effect on M value, the measure of insulin sensitivity for each intervention as assessed by clamp.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired T-test'}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Skeletal muscle insulin sensitivity measured after 28 days of high fat diet. The High Fat diet consists of 60% energy from fat (50% saturated), 15% of energy as carbohydrate and 25% from protein consumed while study intervention is being administered.', 'unitOfMeasure': 'M Value (mg/kg/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Endotoxin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The high fat diet will provide 60% of energy from fat (of which 50% from saturated fat), 15% of energy as CHO and 25% from protein.\n\nsubjects will be randomized to receive, in a double-blind fashion\n\nMaltodextrin: This is a control group. Maltodextrin, 6 g three times a day'}, {'id': 'OG001', 'title': 'Sevelamer', 'description': 'The high fat diet will provide 60% of energy from fat (of which 50% from saturated fat), 15% of energy as CHO and 25% from protein.\n\nsubjects will be randomized to receive, in a double-blind fashion Sevelamer: 1.6 g sevelamer + 4.4 g maltodextrin three times a day'}, {'id': 'OG002', 'title': 'Synbiotic', 'description': 'The high fat diet will provide 60% of energy from fat (of which 50% from saturated fat), 15% of energy as CHO and 25% from protein.\n\nsubjects will be randomized to receive, in a double-blind fashion Synbiotic: 5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day.'}], 'timeFrame': 'At baseline, on day 3, and 28 of the intervention.', 'description': 'Endotoxin is a bacterially derived product that we hypothesized would impact insulin sensitivity through pro inflammatory pathways.', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma Endotoxin levels not analyzed after study completed enrollment due to low subject enrollment and limited ability to compare between subjects (max n=3 per group)'}, {'type': 'SECONDARY', 'title': 'Gut Permeability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The high fat diet will provide 60% of energy from fat (of which 50% from saturated fat), 15% of energy as CHO and 25% from protein.\n\nsubjects will be randomized to receive, in a double-blind fashion\n\nMaltodextrin: This is a control group. Maltodextrin, 6 g three times a day'}, {'id': 'OG001', 'title': 'Sevelamer', 'description': 'The high fat diet will provide 60% of energy from fat (of which 50% from saturated fat), 15% of energy as CHO and 25% from protein.\n\nsubjects will be randomized to receive, in a double-blind fashion Sevelamer: 1.6 g sevelamer + 4.4 g maltodextrin three times a day'}, {'id': 'OG002', 'title': 'Synbiotic', 'description': 'The high fat diet will provide 60% of energy from fat (of which 50% from saturated fat), 15% of energy as CHO and 25% from protein.\n\nsubjects will be randomized to receive, in a double-blind fashion Synbiotic: 5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day.'}], 'timeFrame': 'on Day 24 of the intervention.', 'description': 'Gut permeability is measured using a lactulose/mannitol ingestion assay where urine samples are collected to analyse the ratio of excreted lactulose:mannitol.', 'reportingStatus': 'POSTED', 'populationDescription': 'Gut permeability not analyzed after study completed enrollment due to low subject enrollment and limited ability to compare between subjects (max n=3 per group)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'placebo, maltodextrin, 6 g three times a day during diet\n\nThis is a control group.'}, {'id': 'FG001', 'title': 'Sevelamer', 'description': 'Sevelamer: 1.6 g sevelamer + 4.4 g maltodextrin three times a day during diet'}, {'id': 'FG002', 'title': 'Synbiotic', 'description': '5g Oligofructose + 4x1010 Bifidobacterium longum CFU 3x daily during diet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Subjects gave informed consent to be screened for study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Subjects Randomized to Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Low Fat Diet', 'achievements': [{'comment': '2 subjects did not complete and were withdrawn', 'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'High Fat Diet', 'achievements': [{'comment': '1 subject did not complete', 'groupId': 'FG000', 'numSubjects': '2'}, {'comment': 'One subject withdrew (low fat diet had already been completed)', 'groupId': 'FG001', 'numSubjects': '5'}, {'comment': 'One subject withdrew and did not complete the low fat diet', 'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Screen Fail', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Subjects were initially screened by BMI and glucose tolerance via OGTT. Qualified Study participants were then assigned to begin a low or high isocaloric diet and then randomized to one of the 3 arms for 4 weeks. After a 10-12 week washout, subjects are changed over to the other diet and remain in the same arm of the study that they were in previously.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'placebo, maltodextrin, 6 g three times a day'}, {'id': 'BG001', 'title': 'Sevelamer', 'description': 'Sevelamer: 1.6 g sevelamer + 4.4 g maltodextrin three times a day'}, {'id': 'BG002', 'title': 'Synbiotic', 'description': '\\*synbiotic \\[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion CFU/g)three times a day\\]'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '0', 'groupId': 'BG000'}, {'value': '40.5', 'spread': '22.0', 'groupId': 'BG001'}, {'value': '59', 'spread': '3.8', 'groupId': 'BG002'}, {'value': '50.6', 'spread': '18.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline participants were consented and passed screening and completed both high fat and low fat diet while randomized to one of the interventions.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-08-16', 'size': 980506, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-29T10:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-15', 'studyFirstSubmitDate': '2014-04-24', 'resultsFirstSubmitDate': '2020-08-10', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-15', 'studyFirstPostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Sensitivity Low Fat Diet', 'timeFrame': 'Day 28', 'description': 'Skeletal muscle insulin sensitivity measured after 28 days of low fat diet and drug intervention. The isocaloric low fat diet will provide 55% energy from carbohydrates, 20% from fat and 25% from protein.'}, {'measure': 'Insulin Sensitivity High Fat Diet', 'timeFrame': 'Day 28', 'description': 'Skeletal muscle insulin sensitivity measured after 28 days of high fat diet. The High Fat diet consists of 60% energy from fat (50% saturated), 15% of energy as carbohydrate and 25% from protein consumed while study intervention is being administered.'}], 'secondaryOutcomes': [{'measure': 'Plasma Endotoxin Levels', 'timeFrame': 'At baseline, on day 3, and 28 of the intervention.', 'description': 'Endotoxin is a bacterially derived product that we hypothesized would impact insulin sensitivity through pro inflammatory pathways.'}, {'measure': 'Gut Permeability', 'timeFrame': 'on Day 24 of the intervention.', 'description': 'Gut permeability is measured using a lactulose/mannitol ingestion assay where urine samples are collected to analyse the ratio of excreted lactulose:mannitol.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Insulin Sensitivity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine insulin sensitivity in individuals that are lean normal glucose tolerant subjects after consumption of a normal low fat diet and after a high fat diet and to explore the effects of high fat consumption on the intestinal microbiome, and metabolic endotoxemia.( Aim 1 of the protocol, a separate record is available for Aim 2)', 'detailedDescription': 'We will test the hypothesis that a high fat diet given to lean, normal glucose tolerant subjects will impair insulin signaling and sensitivity and modify gut microbiome composition and enhance intestinal permeability, which will increase plasma LPS concentration, induce an inflammatory response in peripheral tissues (skeletal muscle). Also we will test the hypothesis that the inflammatory response and insulin resistance caused by high fat ingestion can be ameliorated by administering\n\n* a synbiotic (Bifidobacterium longum R0175 and oligofructose) which protects the intestinal epithelial barrier and decreases intestinal translocation of LPS; and\n* sevelamer, an agent which sequesters lipopolysaccharide (LPS) in the gastrointestinal tract limiting its translocation into the circulation.\n\nAll subjects are fed both a low fat diet (considered a normal diet) and high fat diet, first one and then the other in no particular sequence. After a washout period participants are fed the other type of high or low fat diet, depending on which diet they were first assigned to in order to compare the effects of the intervention on insulin sensitivity during each diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders. All races and ethnic groups.\n* Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for ≥6 months.\n* Hematocrit (HCT)≥ 34%, serum creatinine ≤ 1.4 mg/dl, and normal serum electrolytes, urinalysis, and coagulation tests. Liver function tests (LFTs) up to 2 times normal.\n* Stable body weight (±2%) for ≥ 3 months\n* Two or less sessions of strenuous exercise/wk for last 6 months.\n\nExclusion Criteria:\n\n* Presence of diabetes or impaired glucose tolerance based on ADA criteria.\n* Current treatment with drugs known to affect glucose and lipid homeostasis. If the subject has been on a stable dose for the past 3 months, the following agents will be permitted: calcium channel blockers, β-blockers, ACE inhibitors, angiotensin receptor blockers, and statins\n* History of allergy to sevelamer.\n* History of Non-steroidal anti-inflammatory drugs or systemic steroid use for more than a week within 3 months.\n* Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsy in accordance with the primary physician.\n* Use of agents that affect gut flora (e.g. antibiotics, colestyramine, lactulose, PEG) within 3 months.\n* History of heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers.\n* Poorly controlled blood pressure (systolic BP\\>170, diastolic BP\\>95 mmHg).\n* Active inflammatory, autoimmune, hepatic, gastrointestinal, malignant, and psychiatric disease.\n* History of gastrointestinal surgery or gastrointestinal obstruction within two years.'}, 'identificationModule': {'nctId': 'NCT02124759', 'acronym': 'MicroB1', 'briefTitle': 'Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1)', 'orgStudyIdInfo': {'id': 'HSC20130459H'}, 'secondaryIdInfos': [{'id': 'IRB #20130458H', 'type': 'OTHER_GRANT', 'domain': 'American Diabetes Association'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo: maltodextrin, 6 g three times a day', 'interventionNames': ['Drug: Maltodextrin', 'Other: High Fat diet', 'Other: Low Fat diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sevelamer', 'description': 'Sevelamer: (1.6 g sevelamer + 4.4 g maltodextrin three times a day)', 'interventionNames': ['Drug: Sevelamer', 'Other: High Fat diet', 'Other: Low Fat diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Synbiotic', 'description': 'Synbiotic: 5g Oligofructose + 4x1010 Bifidobacterium longum CFU 3x daily during diet', 'interventionNames': ['Drug: Synbiotic', 'Other: High Fat diet', 'Other: Low Fat diet']}], 'interventions': [{'name': 'Sevelamer', 'type': 'DRUG', 'otherNames': ['Renvela'], 'description': '1.6 g sevelamer + 4.4 g maltodextrin three times a day', 'armGroupLabels': ['Sevelamer']}, {'name': 'Synbiotic', 'type': 'DRUG', 'description': '5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day.', 'armGroupLabels': ['Synbiotic']}, {'name': 'Maltodextrin', 'type': 'DRUG', 'description': 'This is a control group. Maltodextrin, 6 g three times a day', 'armGroupLabels': ['Placebo']}, {'name': 'High Fat diet', 'type': 'OTHER', 'otherNames': ['Isocaloric high fat diet'], 'description': 'The High Fat diet consists of 60% energy from fat (50% saturated), 15% of energy as carbohydrate and 25% from protein consumed while study intervention is being administered.', 'armGroupLabels': ['Placebo', 'Sevelamer', 'Synbiotic']}, {'name': 'Low Fat diet', 'type': 'OTHER', 'otherNames': ['Isocaloric low fat (normal) diet'], 'description': 'The isocaloric low fat diet will provide 55% energy from carbohydrates, 20% from fat and 25% from protein.', 'armGroupLabels': ['Placebo', 'Sevelamer', 'Synbiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Audie L. Murphy VA Hospital, STVHCS', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Nicolas Musi, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}