Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT01877551
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2013-06-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance
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': 'C031655', 'term': 'ursodoxicoltaurine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dreeds@wustl.edu', 'phone': '3143628430', 'title': 'Dr. Dominic Reeds', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We were unable to recruit our targeted enrollment reducing the power of the study'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were taken over a 6 week period after initiation of drug or placebo', 'description': 'Subjects were followed for 6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Tauroursodeoxycholic Acid', 'description': 'This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.\n\nTauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.\n\nPlacebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'influenza', 'notes': 'patient contracted influenza during study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glucose Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tauroursodeoxycholic Acid', 'description': 'This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.\n\nTauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.\n\nPlacebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '11', 'groupId': 'OG000'}, {'value': '8', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Glucose uptake is measured at baseline and 30 days after study intervention', 'description': 'We will examine the ability of insulin to cause muscle to take up insulin. Each subject will receive intravenous insulin for 6 hours to see how much sugar needs to be given intravenously to keep the blood sugar normal, a measure called glucose uptake. We will compare glucose uptake measured as the amount of 20% dextrose that is needed to keep the blood sugar at \\~100mg/dl during insulin infusion before and after 30 days of treatment with drug or placebo.', 'unitOfMeasure': 'change in glucose infusion rate (ml/hr)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tauroursodeoxycholic Acid', 'description': 'This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.\n\nTauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.\n\nPlacebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '35.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '32.6', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '35.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '31.7', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Treatment and Post 30 day-Treatment', 'description': 'We will measure how much fat is present in each subject before and after treatment with TUDCA or placebo.', 'unitOfMeasure': 'percentage of body fat', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Liver Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tauroursodeoxycholic Acid', 'description': 'This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.\n\nTauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.\n\nPlacebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Treatment and Post 30 day-Treatment', 'description': "We will use MRI to measure the relative (%) amount of fat in each subject's liver before and after 30 days of treatment. This will allow us to determine if the drug reduces liver fat. This is calculated by subtracting the amount of fat in the liver at the beginning of the study from the amount of fat in the liver after 30 days of treatment. Subjects who have claustrophobia or are unable to undergo MRI will not have this measure performed. Due to these reasons liver MRS was only performed in 10 patients in the tauroursodeoxycholic acid group and 9 subjects in the placebo group", 'unitOfMeasure': 'Change in Percent liver fat', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Liver Function Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tauroursodeoxycholic Acid', 'description': 'This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.\n\nTauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.\n\nPlacebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.'}], 'classes': [{'title': 'ALT-PRE', 'categories': [{'measurements': [{'value': '25', 'spread': '4', 'groupId': 'OG000'}, {'value': '21', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'ALT-Post', 'categories': [{'measurements': [{'value': '19', 'spread': '3', 'groupId': 'OG000'}, {'value': '23', 'spread': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Treatment and Post 30 day-Treatment', 'description': 'We will measure liver function tests before and after the study drug to ensure that no abnormalities in liver function occurs with the drug.', 'unitOfMeasure': 'ALT (IU/ml)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tauroursodeoxycholic Acid', 'description': 'This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.\n\nTauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.\n\nPlacebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tauroursodeoxycholic Acid', 'description': 'This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.\n\nTauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.\n\nPlacebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.'}, {'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': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', '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': 'one subject in the control group developed influenza during the study and was excluded from final analysis'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '11', 'groupId': 'BG000'}, {'value': '51', 'spread': '10', 'groupId': 'BG001'}, {'value': '48', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', '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'}, {'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': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-06', 'size': 1110900, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-15T11:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-23', 'studyFirstSubmitDate': '2013-06-11', 'resultsFirstSubmitDate': '2019-05-31', 'studyFirstSubmitQcDate': '2013-06-12', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-23', 'studyFirstPostDateStruct': {'date': '2013-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose Uptake', 'timeFrame': 'Glucose uptake is measured at baseline and 30 days after study intervention', 'description': 'We will examine the ability of insulin to cause muscle to take up insulin. Each subject will receive intravenous insulin for 6 hours to see how much sugar needs to be given intravenously to keep the blood sugar normal, a measure called glucose uptake. We will compare glucose uptake measured as the amount of 20% dextrose that is needed to keep the blood sugar at \\~100mg/dl during insulin infusion before and after 30 days of treatment with drug or placebo.'}], 'secondaryOutcomes': [{'measure': 'Body Composition', 'timeFrame': 'Pre-Treatment and Post 30 day-Treatment', 'description': 'We will measure how much fat is present in each subject before and after treatment with TUDCA or placebo.'}, {'measure': 'Liver Fat', 'timeFrame': 'Pre-Treatment and Post 30 day-Treatment', 'description': "We will use MRI to measure the relative (%) amount of fat in each subject's liver before and after 30 days of treatment. This will allow us to determine if the drug reduces liver fat. This is calculated by subtracting the amount of fat in the liver at the beginning of the study from the amount of fat in the liver after 30 days of treatment. Subjects who have claustrophobia or are unable to undergo MRI will not have this measure performed. Due to these reasons liver MRS was only performed in 10 patients in the tauroursodeoxycholic acid group and 9 subjects in the placebo group"}, {'measure': 'Liver Function Tests', 'timeFrame': 'Pre-Treatment and Post 30 day-Treatment', 'description': 'We will measure liver function tests before and after the study drug to ensure that no abnormalities in liver function occurs with the drug.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Protease inhibitor', 'insulin resistance', 'Tauroursodeoxycholic acid'], 'conditions': ['HIV Related Insulin Resistance', 'Protease Inhibitor Related Insulin Resistance', 'Endoplasmic Reticulum Stress']}, 'referencesModule': {'references': [{'pmid': '20522594', 'type': 'BACKGROUND', 'citation': 'Kars M, Yang L, Gregor MF, Mohammed BS, Pietka TA, Finck BN, Patterson BW, Horton JD, Mittendorfer B, Hotamisligil GS, Klein S. Tauroursodeoxycholic Acid may improve liver and muscle but not adipose tissue insulin sensitivity in obese men and women. Diabetes. 2010 Aug;59(8):1899-905. doi: 10.2337/db10-0308. Epub 2010 Jun 3.'}], 'seeAlsoLinks': [{'url': 'http://actu.im.wustl.edu', 'label': 'Washington University AIDS Clinical Trials Unit'}]}, 'descriptionModule': {'briefSummary': 'Rates of cardiovascular disease and diabetes are more than 2-fold greater in HIV infected people than the general population. Protease inhibitor booster antiretroviral therapy (PI-ART) which is used by \\~50% of HIV infected people in the USA is an established risk factor for diabetes. Tauroursodeoxycholic acid (TUDCA), a naturally occurring bile salt, improves insulin sensitivity in HIV uninfected subjects, although the mechanisms for these benefits are unclear. This study will explore the hypothesis that TUDCA will improve insulin action in people with HIV who are receiving PI-ART. Further, this project will clarify the molecular mechanisms responsible for these improvements potentially benefiting society, irrespective of HIV status.', 'detailedDescription': 'The purpose of this study is to determine if, and through which mechanisms, tauroursodeoxycholic acid improves insulin sensitivity in subjects with protease-inhibitor associated insulin resistance.\n\nThe investigators will perform body composition analysis by using a DEXA machine, liver fat measurement by using an MRI, and hyperinsulinemic euglycemic clamp procedures in 48 HIV infected, insulin-resistant/prediabetic subjects before and after 30 days of treatment with tauroursodeoxycholic acid or matching placebo. Biopsies of adipose tissue and skeletal muscle will be taken during fasting conditions and during insulin infusion, before and after treatment to measure markers of endoplasmic reticulum stress and thyroid hormone deiodinase.\n\nOutcome measures:\n\nThe primary outcome measures will be change in glucose clearance during insulin infusion, change in markers of endoplasmic reticulum stress and change in content of D2 in muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV+\n* receiving protease inhibitor containing antiretroviral therapy for \\>6 months\n* Undetectable viral load\n* insulin resistant\n\n 1. impaired fasting glucose (fasting blood glucose\\>100mg/dl)\n 2. impaired glucose tolerance (blood glucose \\>140mg/dl at 2 hours during oral glucose tolerance testing).\n* abstained from medications that affect glucose (e.g. prednisone, growth hormone)\n* stable medications for \\>3 months\n\nExclusion Criteria:\n\n* weight loss of \\>5% of body weight in prior 6 months\n* active gastrointestinal disease (gallstones, pancreatitis, hepatitis, diarrhea)\n* use of anti-diabetic medications\n* cardiovascular disease (uncontrolled hypertension, heart attack, heart failure, prior endocarditis)\n* history of or active substance abuse\n* blood clotting disorder or taking medications that affect blood clotting (e.g. coumadin, warfarin)\n* pregnant, planning to become pregnant or lactating\n* unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT01877551', 'briefTitle': 'Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance', 'orgStudyIdInfo': {'id': '201306105'}, 'secondaryIdInfos': [{'id': 'R01DK096982', 'link': 'https://reporter.nih.gov/quickSearch/R01DK096982', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tauroursodeoxycholic acid', 'description': 'This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.', 'interventionNames': ['Drug: Tauroursodeoxycholic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.', 'interventionNames': ['Other: Placebo tablet']}], 'interventions': [{'name': 'Tauroursodeoxycholic acid', 'type': 'DRUG', 'otherNames': ['taurolite', 'tudcabil'], 'description': 'The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.', 'armGroupLabels': ['tauroursodeoxycholic acid']}, {'name': 'Placebo tablet', 'type': 'OTHER', 'description': 'The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Dominic N. Reeds, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}