Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-29 @ 12:03 PM
Study NCT ID:
NCT01326533
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2011-03-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '.toledofs@upmc.edu', 'phone': '412-692-2848', 'title': 'Frederico Toledo', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During 13 weeks of treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine sulfate PO 400mg/day', 'otherNumAtRisk': 17, 'otherNumAffected': 3, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo PO', 'otherNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Unusual or vivid dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia or GI discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': '400 mg PO daily for 13 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'PO daily for 13 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline value as covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '13 weeks after baseline measurement', 'description': 'Change from baseline in the insulin sensitivity index (Si)', 'unitOfMeasure': '10^-4/pmol*l/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized with last observation carried forward for missing data'}, {'type': 'SECONDARY', 'title': 'Beta Cell Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': '400 mg PO daily for 13 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'PO daily for 13 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '352', 'spread': '143', 'groupId': 'OG000'}, {'value': '-218', 'spread': '158', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline value as covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '13 weeks after baseline measurement', 'description': 'Change from baseline in the disposition index (DI)', 'unitOfMeasure': 'arbitrary units', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized with last observation carried forward for missing data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hydroxychloroquine', 'description': '13 weeks of hydroxychloroquine sulfate PO 400 mg/day'}, {'id': 'FG001', 'title': 'Placebo', 'description': '13 weeks of placebo PO'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine sulfate PO 400 mg daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '44.9', 'spread': '16.8', 'groupId': 'BG001'}, {'value': '47.6', 'spread': '15.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insulin sensitivity (Si)', 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'spread': '0.27', 'groupId': 'BG000'}, {'value': '0.58', 'spread': '0.42', 'groupId': 'BG001'}, {'value': '0.55', 'spread': '0.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^-4 / pmol*l / min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Beta cell function (disposition index)', 'classes': [{'categories': [{'measurements': [{'value': '1721', 'spread': '2014', 'groupId': 'BG000'}, {'value': '1214', 'spread': '691', 'groupId': 'BG001'}, {'value': '1483', 'spread': '1540', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'arbitrary units', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2011-03-29', 'resultsFirstSubmitDate': '2015-12-22', 'studyFirstSubmitQcDate': '2011-03-29', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-22', 'studyFirstPostDateStruct': {'date': '2011-03-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Sensitivity', 'timeFrame': '13 weeks after baseline measurement', 'description': 'Change from baseline in the insulin sensitivity index (Si)'}], 'secondaryOutcomes': [{'measure': 'Beta Cell Function', 'timeFrame': '13 weeks after baseline measurement', 'description': 'Change from baseline in the disposition index (DI)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pre-diabetes', 'hydroxychloroquine', 'frequently sampled intravenous glucose tolerance testing', 'insulin resistance', 'insulin secretion', 'glucose tolerance'], 'conditions': ['Pre-diabetes']}, 'referencesModule': {'references': [{'pmid': '26197707', 'type': 'DERIVED', 'citation': 'Wasko MC, McClure CK, Kelsey SF, Huber K, Orchard T, Toledo FG. Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial. Diabetologia. 2015 Oct;58(10):2336-43. doi: 10.1007/s00125-015-3689-2. Epub 2015 Jul 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the short-term effects of the antimalarial medication, hydroxychloroquine (HCQ), compared with placebo using frequently sampled intravenous glucose tolerance testing (FSIGTT) methodology to study changes in insulin secretion and glucose tolerance in subjects at risk for developing Type 2 diabetes.', 'detailedDescription': 'Diabetes is approaching epidemic proportions in the United States. This study evaluates the mechanisms of action of a generic drug that may have effects on glucose metabolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age \\> or = 18, able to provide informed consent\n2. Body-mass index greater than or equal to 25\n3. Presence of at least one indicator of insulin resistance from the following list:\n\n * Family history of Type 2 diabetes (parent, sibling)\n * Fasting glucose 100 - 125 mg/dl\n * Fasting serum insulin greater than or equal to 7uU/ml\n * Personal history of gestational diabetes\n4. Negative pregnancy test for women with childbearing potential\n\nExclusion Criteria:\n\n1. Diagnosis of diabetes mellitus Type 1 or Type 2\n2. Active autoimmune disease, chronic infection, current malignancy (excluding basal cell carcinoma), or other active inflammatory state that, in the opinion of the investigators, would affect insulin sensitivity\n3. Oral corticosteroid use in prior six months, or expectation of needing corticosteroid therapy in upcoming six months\n4. Known allergy or intolerance to HCQ\n5. Known glucose-6 phosphate dehydrogenase deficiency\n6. Known eye disease associated with retinal pigmentation abnormalities\n7. Known diabetic retinopathy requiring past or planned laser therapy\n8. Inability to comply with visit schedule and protocol requirements\n9. Inability to manage and take medication as instructed\n10. Current or planned pregnancy in upcoming 12 months\n11. Inability or unwillingness to use reliable method of contraception (for women of childbearing years, men, or men's partners with childbearing potential), such as oral contraceptive pills, barrier method (diaphragm and condom with spermicide), intrauterine device, or depo-provera injections for 3 months prior to enrollment\n12. Anemia (HGB \\< 9)\n13. Any history of bariatric (weight loss) surgery\n14. Current use of the medication Glucophage (metformin)\n15. Weight changes of 6 pounds or more in the past 4 weeks\n16. Any other underlying or concomitant condition, which in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk"}, 'identificationModule': {'nctId': 'NCT01326533', 'briefTitle': 'Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Mechanisms of Action of Hydroxychloroquine in Reducing Risk of Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'DK082878'}, 'secondaryIdInfos': [{'id': '5R21DK082878-02', 'link': 'https://reporter.nih.gov/quickSearch/5R21DK082878-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hydroxychloroquine', 'description': 'Thirteen weeks of daily hydroxychloroquine following FSIGTT testing', 'interventionNames': ['Drug: hydroxychloroquine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Thirteen weeks of daily placebo following FSIGTT testing', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'hydroxychloroquine', 'type': 'DRUG', 'otherNames': ['Plaquenil'], 'description': 'Thirteen weeks of oral hydroxychloroquine (400 mg/day) provided as capsules', 'armGroupLabels': ['hydroxychloroquine']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['microcellulose placebo'], 'description': 'Thirteen weeks of oral placebo provided as capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh, Montefiore Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Frederico Toledo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Frederico Toledo', 'investigatorAffiliation': 'University of Pittsburgh'}}}}