Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT01135394
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2010-06-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacogenomics of Thiazolidinediones
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ssnitker@som.umaryland.edu', 'phone': '4107061511', 'title': 'Soren Snitker, MD, PhD', 'organization': 'University of Maryland School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks (treatment phase) + 4 weeks (follow-up) = 16 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Pioglitazone (Actos)', 'description': 'Participants will have metabolism studies to consist of outpatient X-ray and MR measurements of bone density and body composition, metabolic testing (intravenous glucose tolerance test), and muscle and adipose tissue biopsies. Blood will also be drawn for genetic testing and for microarray studies of leukocytes. Upon completion of the above studies, the participant will begin pioglitazone therapy. Every 4 weeks throughout the drug intervention, glycemic control, lipoprotein profile, and weight will be monitored. After 12 weeks of pioglitazone therapy, the X-ray and MR measurements of body composition, the biopsies, microarray studies for leukocytes and the metabolic tests will be repeated.\n\nPioglitazone: 30 mg tablet once daily for 4 weeks, then increased to 45 mg once daily for an additional 8 weeks. Total dosage period is 12 weeks.', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 15, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hematoma at abdominal fat biopsy site', 'notes': 'Hematoma at abdominal fat biopsy site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia during intravenous glucose tolerance test', 'notes': 'Hypoglycemia during intravenous glucose tolerance test', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasovagal response', 'notes': 'bradycardia secondary to vasovagal response during fat biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Insulin Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone (Actos)', 'description': 'The study is a one-arm design.\n\nAll participants will receive Pioglitazone: 30 mg tablet once daily for 4 weeks, then increased to 45 mg once daily for an additional 8 weeks. Total dosage period is 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.83', 'spread': '1.23', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0000001', 'groupIds': ['OG000'], 'paramType': 'Pearson correlation p-value', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0000001', 'pValueComment': 'The genes with p-values below 10\\^-6 were identified', 'groupDescription': 'After the change (end-of-treatment minus baseline) in HOMA-IR index had been calculated for each subject, the change (end-of-treatment minus baseline) in expression of each of approximately 45,000 transcripts contained in a human gene array was calculated. A Pearson correlation p-value was calculated for the correlation between change in gene expression and change in HOMA-IR index, with the purpose of identifying the genes whose expression changed in concert with changes in HOMA-IR index.', 'statisticalMethod': 'Genes with p-values below 10^-6', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The genes with p-values below 10\\^-6 were identified', 'otherAnalysisDescription': 'The genes with P-values below 10\\^-6 were identified'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change in insulin resistance was calculated as change (end of treatment minus baseline) in HOMA-IR index (glucose (mg/dL) x insulin (μU/mL)/405)', 'unitOfMeasure': 'HOMA-IR index is unitless by definition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Included subjects are those who had complete data, including HOMA-IR index at both baseline and after treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Genes Determined to be Correlated With Change in Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}, {'units': 'Genes', 'counts': [{'value': '53934', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone (Actos)', 'description': 'The study is a one-arm design.\n\nAll participants will receive Pioglitazone: 30 mg tablet once daily for 4 weeks, then increased to 45 mg once daily for an additional 8 weeks. Total dosage period is 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Number of genes determined to be correlated with change in insulin sensitivity as determined by HOMA-IR with a p-value below 0.000001', 'unitOfMeasure': 'Genes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Genes', 'denomUnitsSelected': 'Genes', 'populationDescription': 'Only subjects who had complete RNAseq (RNA sequencing) data and HOMA-IR were included'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pioglitazone (Actos)', 'description': 'Participants will have metabolism studies to consist of outpatient X-ray and magnetic resonance (MR) measurements of bone density and body composition, metabolic testing (intravenous glucose tolerance test), and muscle and adipose tissue biopsies. Blood will also be drawn for genetic testing and for microarray studies of leukocytes. Upon completion of the above studies, the participant will begin pioglitazone therapy. Every 4 weeks throughout the drug intervention, glycemic control, lipoprotein profile, and weight will be monitored. After 12 weeks of pioglitazone therapy, the X-ray and MR measurements of body composition, the biopsies, microarray studies for leukocytes and the metabolic tests will be repeated.\n\nPioglitazone: 30 mg tablet once daily for 4 weeks, then increased to 45 mg once daily for an additional 8 weeks. Total dosage period is 12 weeks.'}], 'periods': [{'title': 'Screening', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Screening failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}, {'title': 'Baseline Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Study Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruitment was through advertisements in local publications and bulletin boards in the University of Maryland and Baltimore area. Additional recruitment among the Old Order Amish was through the University of Maryland Amish Research Clinic in Lancaster County, Pennsylvania.', 'preAssignmentDetails': 'Screening assessments done following informed consent include anthropometry, screening bloodwork, medical history and baseline study assessments. Participants may be excluded prior to start of study drug and/or baseline assessments if they do not meet eligibility criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pioglitazone (Actos)', 'description': 'Participants will have metabolism studies to consist of outpatient X-ray and MR measurements of bone density and body composition, metabolic testing (intravenous glucose tolerance test), and muscle and adipose tissue biopsies. Blood will also be drawn for genetic testing and for microarray studies of leukocytes. Upon completion of the above studies, the participant will begin pioglitazone therapy. Every 4 weeks throughout the drug intervention, glycemic control, lipoprotein profile, and weight will be monitored. After 12 weeks of pioglitazone therapy, the X-ray and MR measurements of body composition, the biopsies, microarray studies for leukocytes and the metabolic tests will be repeated.\n\nPioglitazone: 30 mg tablet once daily for 4 weeks, then increased to 45 mg once daily for an additional 8 weeks. Total dosage period is 12 weeks.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '114', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insulin resistance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.74', 'spread': '1.82', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Homeostatic Model of Insulin Resistance (HOMA-IR) index was calculated as (glucose (mg/dL) x insulin (μU/mL)/405) based on an intravenous glucose tolerance test as per Turner et al.\\* By definition, HOMA-IR index is unitless.\n\n\\*Turner R.C., et al. (1979). "Insulin deficiency and insulin resistance interaction in diabetes: estimation of their relative contribution by feedback analysis from basal plasma insulin and glucose concentrations". Metabolism. 28 (11): 1086-96', 'unitOfMeasure': 'HOMA-IR index is unitless by definition', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'HOMA-IR index was calculated only on subjects who had complete data including both intravenous glucose tolerance tests'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2006-11-27', 'size': 677280, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-27T14:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2010-06-01', 'resultsFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2010-06-01', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-27', 'studyFirstPostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insulin Resistance', 'timeFrame': '12 weeks', 'description': 'Change in insulin resistance was calculated as change (end of treatment minus baseline) in HOMA-IR index (glucose (mg/dL) x insulin (μU/mL)/405)'}], 'secondaryOutcomes': [{'measure': 'Number of Genes Determined to be Correlated With Change in Insulin Sensitivity', 'timeFrame': '12 weeks', 'description': 'Number of genes determined to be correlated with change in insulin sensitivity as determined by HOMA-IR with a p-value below 0.000001'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pioglitazone', 'Type 2 diabetes', 'Insulin sensitivity', 'Healthy adults', 'Thiazolidinediones', 'Pharmacogenetics'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine predictors of response to pioglitazone, an anti-diabetic medication. The investigators know from randomized clinical trials that some 30% of patients do not respond to this type of medication. There is presently no way to identify this group of patients leading to unnecessary drug exposure and medication costs.', 'detailedDescription': 'In phase I, subjects who are eligible based on height and weight and general health information will sign informed consent. In phase II, subjects will be screened to ensure that they fit the inclusion/exclusion criteria, including an oral glucose tolerance test. Other blood tests will be performed to check complete blood count, lipids, liver functions and electrolytes.\n\nQualifying volunteers will enter phase III, which will consist of outpatient radioimaging and body composition, metabolic testing (intravenous glucose tolerance test), and tissue biopsies. Blood will also be drawn for genetic testing and for microarray studies of leukocytes. Written medication information and instructions for pioglitazone, discharge instructions and satisfaction surveys following the tissue biopsy procedures will be given to subjects during the study. During phase IV, subjects will begin pioglitazone therapy. Every 4 weeks throughout the drug intervention, glycemic control, lipoprotein profile, and weight will be monitored. After 12 weeks of pioglitazone therapy, the X-ray and magnetic resonance (MR) measurements of body composition, the biopsies and the metabolic tests performed during phase III will be repeated (phase V), and blood will be drawn for microarray studies of leukocytes.\n\nThereafter, subjects will have the option to be enrolled in a 10 week, behavioral weight loss program (phase VI). Following the 10-week weight loss program, a few outcome measurements will be repeated (phase VII).\n\nThroughout the study, Women of Child Bearing Potential (WCBP) will have human human chorionic gonadotrophin (HCG) urine pregnancy tests. Pregnancy tests will only be performed on Women of childbearing potential, meaning women who are pre-menopausal and who have not had surgical sterilization. Women who have not had a hysterectomy or tubal ligation at least six months prior to signing informed consent or have been postmenopausal for at least one year, will be instructed to practice one of the following methods of birth control throughout the study: oral, transdermal, or implantable hormonal contraceptives, intrauterine device, diaphragm plus spermicide, condom plus spermicide, or abstinence. Pioglitazone may reduce the effectiveness of some hormonal types of contraceptives. Women using hormonal methods of birth control will be advised to use a barrier method as well. Female subjects are informed to notify the investigators immediately if they think they might have become pregnant during the study.\n\nParticipants who are eligible have 10 visits over an approximate 15-week period. Participants can choose to participate in an optional weight management program for an additional 10 weeks after treatment and before their final visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 35-64\n* BMI: ≥ 25 and ≤ 40\n\nExclusion Criteria:\n\n* Pregnancy as determined by urine pregnancy test Breast-feeding, or planning to become pregnant during the study\n* Physical dimensions exceeding the limits of any equipment used\n* Stage III or greater congestive heart failure\n* Symptomatic peripheral vascular disease\n* Stroke\n* Severe hypertension (\\>170/100 mmHg)\n* Anemia (Hgb and Hct \\< normal reference range)\n* Receiving treatment for thyroid, pituitary, kidney or liver disease (except controlled thyroid hormone replacement)\n* History of diabetes (as told by doctor, or taking diabetic medications Fasting glucose value diagnostic for diabetes 2-h oral glucose tolerance test diagnostic for diabetes\n* Rheumatoid arthritis\n* History of wrist, hip or leg fracture after the age of 45\n* History of kidney stones\n* Medications that the investigator judges will make interpretation of the results difficult or increase the risk of participation (e.g. anticoagulants)\n* Any disease or condition that the investigator judges will affect bone metabolism or make interpretation of the results difficult or increase the risk of participation (e.g. anemia, cardiac decompensation, intolerance to pioglitazone, lidocaine, or other agents used)'}, 'identificationModule': {'nctId': 'NCT01135394', 'acronym': 'PPAR', 'briefTitle': 'Pharmacogenomics of Thiazolidinediones', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Pharmacogenomics of Thiazolidinediones', 'orgStudyIdInfo': {'id': 'HP-00043497'}, 'secondaryIdInfos': [{'id': 'R01DK074828', 'link': 'https://reporter.nih.gov/quickSearch/R01DK074828', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pioglitazone (Actos)', 'description': 'Participants will have metabolism studies to consist of outpatient X-ray and MR measurements of bone density and body composition, metabolic testing (intravenous glucose tolerance test), and muscle and adipose tissue biopsies. Blood will also be drawn for genetic testing and for microarray studies of leukocytes. Upon completion of the above studies, the participant will begin pioglitazone therapy. Every 4 weeks throughout the drug intervention, glycemic control, lipoprotein profile, and weight will be monitored. After 12 weeks of pioglitazone therapy, the X-ray and MR measurements of body composition, the biopsies, microarray studies for leukocytes and the metabolic tests will be repeated.', 'interventionNames': ['Drug: Pioglitazone']}], 'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': '30 mg tablet once daily for 4 weeks, then increased to 45 mg once daily for an additional 8 weeks. Total dosage period is 12 weeks.', 'armGroupLabels': ['Pioglitazone (Actos)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Soren Snitker, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Soren Snitker', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}