Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT01692002
Status:
TERMINATED
Last Update Posted:
2025-06-18
First Post:
2012-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Oral Propionate to Treat and Prevent Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C514135', 'term': 'sodium propionate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D005951', 'term': 'Glucose Tolerance Test'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'g.frost9296@gmail.com', 'phone': '07872850308', 'title': 'Prof Gary Frost Head of Section for Nutrition Research', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 week', 'eventGroups': [{'id': 'EG000', 'title': 'Sodium Chloride Pill', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test\n\nSodium Chloride: Placebo capsule or tablet\n\nOral glucose tolerance test\n\nIntravenous glucose tolerance test.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sodium Propionate Pill', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test\n\nSodium propionate: Sodium propionate capsule or tablet\n\nOral glucose tolerance test\n\nIntravenous glucose tolerance test.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Propionate CMax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride Capsule', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test\n\nSodium Chloride: Placebo capsule or tablet\n\nOral glucose tolerance test\n\nIntravenous glucose tolerance test.'}, {'id': 'OG001', 'title': 'Sodium Propionate Capsule', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test\n\nSodium propionate: Sodium propionate capsule or tablet\n\nOral glucose tolerance test\n\nIntravenous glucose tolerance test.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '7.79', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'hours (up to 8hrs)', 'description': 'Study 1: Peak plasma concentration of propionate. Dose ranging and pharmacokinetic profile of propionate by Mass spectrometry has been measured at -10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h (the mean below was estimated first per patient (across all the above time points) and then per arm across the 6 patients)', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Propionate concertation in plasma'}, {'type': 'SECONDARY', 'title': 'Total Amount of Insulin Stimulated by Propionate Per Unit Time (Incremental Area Under the Curve)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride Capsule', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test\n\nSodium Chloride: Placebo capsule or tablet\n\nOral glucose tolerance test\n\nIntravenous glucose tolerance test.'}, {'id': 'OG001', 'title': 'Sodium Propionate Capsule', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test\n\nSodium propionate: Sodium propionate capsule or tablet\n\nOral glucose tolerance test\n\nIntravenous glucose tolerance test.'}], 'classes': [{'categories': [{'measurements': [{'value': '677.5', 'spread': '24', 'groupId': 'OG000'}, {'value': '678', 'spread': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Study 3: Participants will undergo a frequently sampled oral glucose tolerance test (OGTT) to detect changes in insulin sensitivity and beta cell function. Where maximum insulin increments during a glucose tolerance test will be reported on a scale 0 to 1000 where 0 is the lowest and 1000 is the highest outcome', 'unitOfMeasure': 'uM/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Insulinogenic Index (Change in Insulin Divided by the Change in Glucose Over the First 30 Minutes of the Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride Capsule', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test\n\nSodium Chloride: Placebo capsule or tablet\n\nOral glucose tolerance test\n\nIntravenous glucose tolerance test.'}, {'id': 'OG001', 'title': 'Sodium Propionate Capsule', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test\n\nSodium propionate: Sodium propionate capsule or tablet\n\nOral glucose tolerance test\n\nIntravenous glucose tolerance test.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'spread': '12', 'groupId': 'OG000'}, {'value': '31', 'spread': '12.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30mins', 'description': 'Study 2: insulinogenic index. Oral glucose tolerance dose finding was measured with commercially available kits (the mean below was estimated per arm across the 6 patients)', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This index is estimated on a scale 0 to 50 where 0 is the lowest value and 50 is the highest value'}, {'type': 'SECONDARY', 'title': 'Insulin Levels in Response to the Absorption of Proprionate (Total Insulin Across All Time Points)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride Capsule', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test\n\nSodium Chloride: Placebo capsule or tablet\n\nOral glucose tolerance test\n\nIntravenous glucose tolerance test.'}, {'id': 'OG001', 'title': 'Sodium Propionate Capsule', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test\n\nSodium propionate: Sodium propionate capsule or tablet\n\nOral glucose tolerance test\n\nIntravenous glucose tolerance test.'}], 'classes': [{'categories': [{'measurements': [{'value': '8142', 'groupId': 'OG000', 'lowerLimit': '6809', 'upperLimit': '9737'}, {'value': '8316', 'groupId': 'OG001', 'lowerLimit': '7148', 'upperLimit': '9674'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'hours (up to 8 hours)', 'description': 'Plasma insulin has been measured using commercially available kits at -10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h (the mean below was estimated first per patient (across all the above time points) and then per arm across the 6 patients)', 'unitOfMeasure': 'uM/l', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mean below was estimated first per patient (across all the above time points) and then per arm across the 6 patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sodium Chloride Pill', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test\n\nSodium Chloride: Placebo capsule or tablet\n\nOral glucose tolerance test\n\nIntravenous glucose tolerance test.'}, {'id': 'FG001', 'title': 'Sodium Propionate Pill', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test\n\nSodium propionate: Sodium propionate capsule or tablet\n\nOral glucose tolerance test\n\nIntravenous glucose tolerance test.'}], 'periods': [{'title': '1st Period of the Cross-over Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '2nd Period of the Cross-over Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment started March 2013 and ended August 2016. The study was based at the clinical research facility at Imperial College Health Care Trust but never completed. Only 6 where recriuted and completed. The target was 12', 'preAssignmentDetails': 'Wash out of 7 days between interventions'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sodium Chloride', 'description': 'Sodium Chloride Pill Intervention'}, {'id': 'BG001', 'title': 'Sodium Propionate', 'description': 'Sodium propionate pill'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '3 dropped out'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '3 dropped out'}, {'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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '3 dropped out'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '3 dropped out'}, {'title': 'Propionate', 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.05', 'groupId': 'BG000'}, {'value': '0.05', 'spread': '0.05', 'groupId': 'BG001'}, {'value': '0.05', 'spread': '0.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'micromol/l', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '3 dropped out'}], 'populationDescription': 'only 6 where recriuted and completed'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-10-01', 'size': 371472, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-28T06:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'the study was terminated so data were referred to only 6 people despite a target recruitment of 12'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'The person who was running the study never completed it, as the study never reached the target recruitment levels.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2012-09-11', 'resultsFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2012-09-20', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-02', 'studyFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Propionate CMax', 'timeFrame': 'hours (up to 8hrs)', 'description': 'Study 1: Peak plasma concentration of propionate. Dose ranging and pharmacokinetic profile of propionate by Mass spectrometry has been measured at -10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h (the mean below was estimated first per patient (across all the above time points) and then per arm across the 6 patients)'}], 'secondaryOutcomes': [{'measure': 'Total Amount of Insulin Stimulated by Propionate Per Unit Time (Incremental Area Under the Curve)', 'timeFrame': '10 minutes', 'description': 'Study 3: Participants will undergo a frequently sampled oral glucose tolerance test (OGTT) to detect changes in insulin sensitivity and beta cell function. Where maximum insulin increments during a glucose tolerance test will be reported on a scale 0 to 1000 where 0 is the lowest and 1000 is the highest outcome'}, {'measure': 'Insulinogenic Index (Change in Insulin Divided by the Change in Glucose Over the First 30 Minutes of the Test)', 'timeFrame': '30mins', 'description': 'Study 2: insulinogenic index. Oral glucose tolerance dose finding was measured with commercially available kits (the mean below was estimated per arm across the 6 patients)'}, {'measure': 'Insulin Levels in Response to the Absorption of Proprionate (Total Insulin Across All Time Points)', 'timeFrame': 'hours (up to 8 hours)', 'description': 'Plasma insulin has been measured using commercially available kits at -10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h (the mean below was estimated first per patient (across all the above time points) and then per arm across the 6 patients)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Propionate'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The aim of these studies is to firstly determine the pharmacokinetic profile of orally administered enteric coated sodium propionate. Subsequently, the most efficacious dose at improving glucose tolerance following an oral glucose challenge will be determined. The investigators will then determine the mechanism of action of propionate, whether it acts by altering beta cell function directly or by augmenting the incretin effect or both', 'detailedDescription': 'The NHS spends £1M per hour, 10% of its yearly budget, treating diabetes. In the UK cases of diabetes are expected to top 4 million by 2025. There is an urgent need for new therapies. The short chain fatty acid propionate is a natural substance produced by digestion of fermentable carbohydrates. Preclinical and early human data demonstrate it improves pancreatic function and glucose control. The investigators aim to conduct proof of principle studies to determine if oral delivery of propionate improves glucose control in patients at risk of developing diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nStudy 1: Healthy men and women aged between 18 and 70 years with BMI between 20-25 kg/m2 and with normal fasting blood glucose (below5.5mmol/l and HbA1C less than 5.7% will be eligible to volunteer.\n\nStudy 2: As for Study 1. Study 3: Cohort 1: Volunteers aged between 30 to 70 with a BMI between 25-35 kg/m2 who do not have impaired fasting glucose and have HbA1c below 5.7%.\n\nCohort 2: Volunteers aged between 30 to 70 years with a BMI between 25-35 kg/m2 who have impaired fasting glucose (between 5.5-7mmol/l) and HbA1C between 5.7% and 6.5%,\n\n* Exclusion Criteria:• Type 1 or Type 2 Diabetes\n\n * Gained or lost ≥ 3kg weight in the past three months\n * Taken prescription medicines having an impact on metabolism, appetite regulation, glucose homeostasis and hormonal regulation\n * Taken any dietary supplements in the last 6 months\n * Any chronic illness\n * Cardiovascular disease\n * Excess alcohol intake\n * Current smokers\n * Any gastrointestinal disorder e.g. Crohn's disease, coeliac disease or irritable bowel syndrome\n * A history of drug or alcohol abuse in the last 2 years\n * Pregnancy (all women of child bearing age will undergo a pregnancy test).\n * Pancreatitis\n * Use of medications likely to interfere with glucose metabolism, appetite regulation, hormonal balance."}, 'identificationModule': {'nctId': 'NCT01692002', 'briefTitle': 'Oral Propionate to Treat and Prevent Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Development of Orally Administered Sodium Propionate to Treat and Prevent Diabetes', 'orgStudyIdInfo': {'id': 'CRO2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium chloride pill', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test', 'interventionNames': ['Dietary Supplement: Sodium Chloride', 'Procedure: Oral glucose tolerance test', 'Procedure: Intravenous glucose tolerance test.']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium propionate pill', 'description': 'Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test', 'interventionNames': ['Dietary Supplement: Sodium propionate', 'Procedure: Oral glucose tolerance test', 'Procedure: Intravenous glucose tolerance test.']}], 'interventions': [{'name': 'Sodium propionate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Sodium propionate capsule or tablet', 'armGroupLabels': ['Sodium propionate pill']}, {'name': 'Sodium Chloride', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo capsule or tablet', 'armGroupLabels': ['Sodium chloride pill']}, {'name': 'Oral glucose tolerance test', 'type': 'PROCEDURE', 'armGroupLabels': ['Sodium chloride pill', 'Sodium propionate pill']}, {'name': 'Intravenous glucose tolerance test.', 'type': 'PROCEDURE', 'armGroupLabels': ['Sodium chloride pill', 'Sodium propionate pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W12 0NN', 'city': 'London', 'state': 'UK', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 0NN', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 0NN', 'city': 'London', 'country': 'United Kingdom', 'facility': 'St John McMichael Centre - Imperial College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Gavin A Bewick, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}