Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT01322035
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2010-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Erythrocyte and Adipocyte G6PD Activity Levels in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brichards@health.southalabama.edu', 'phone': '251-471-7993', 'title': 'Dr. William O. Richards', 'organization': 'University of South Alabama, Department of Surgery'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'baseline to 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Type 2 Diabetic', 'description': 'no adverse events occurred', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nondiabetic', 'description': 'no adverse events occurred', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetic', 'description': 'morbidly obese patients'}, {'id': 'OG001', 'title': 'Nondiabetic', 'description': 'nondiabetic morbidly obese'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.12', 'spread': '5.22', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': '1 week post surgery', 'categories': [{'measurements': [{'value': '22', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '13', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': '6 week post surgery', 'categories': [{'measurements': [{'value': '20', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '12', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': '12 week post surgery', 'categories': [{'measurements': [{'value': '7.58', 'spread': '9.81', 'groupId': 'OG000'}, {'value': '11.72', 'spread': '14.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': '95% confidence limits from standard deviation', 'nonInferiorityComment': '95% confidence limits from standard deviation of the mean were used as the equivalence.'}], 'paramType': 'MEAN', 'timeFrame': 'G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, and 12 weeks post surgery.', 'description': 'G6PD levels will be measured various time intervals. G6PD is the rate limiting enzyme of the pentose phosphate pathway that provides NADPH required for lipid synthesis. G6PD overexpression is implicated in insulin resistance, hyperlipidemia and increases in oxidative stress.', 'unitOfMeasure': 'nM/min/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetic', 'description': 'morbidly obese type 2 diabetic patients'}, {'id': 'OG001', 'title': 'Nondiabetic', 'description': 'morbidly obese nondiabetic patients'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.12', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': '1 week postop', 'categories': [{'measurements': [{'value': '22.1', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '13', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '21.9', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': '12 weeks post surgery', 'categories': [{'measurements': [{'value': '8', 'spread': '2', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, and 12 weeks post surgery.', 'description': 'G6PD levels will be measured various time intervals. G6PD is the rate limiting enzyme of the pentose phosphate pathway that provides NADPH required for lipid synthesis. G6PD overexpression is implicated in insulin resistance, hyperlipidemia and increases in oxidative stress.', 'unitOfMeasure': 'nM/min/mg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Measure Omentum G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetic', 'description': 'morbidly obese type 2 diabetic patients'}, {'id': 'OG001', 'title': 'Nondiabetic', 'description': 'morbidly obese nondiabetic patients'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '3', 'groupId': 'OG000'}, {'value': '12', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'time of gastric bypass', 'unitOfMeasure': 'nM/min/mg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Measure Hepatocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetic', 'description': 'morbidly obese type 2 diabetic patients'}, {'id': 'OG001', 'title': 'Nondiabetic', 'description': 'morbidly obese nondiabetic patients'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'spread': '2', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'time of gastric bypass', 'unitOfMeasure': 'nM/min/mg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Type 2 Diabetic', 'description': 'morbidly obese type 2 diabetic patients'}, {'id': 'FG001', 'title': 'Nondiabetic', 'description': 'morbidly obese nondiabetic patients'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Type 2 Diabetic', 'description': 'morbidly obese type 2 diabetic patients'}, {'id': 'BG001', 'title': 'Nondiabetic', 'description': 'morbidly obese nondiabetic patients'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.20', 'spread': '2.52', 'groupId': 'BG000'}, {'value': '44', 'spread': '3.40', 'groupId': 'BG001'}, {'value': '45.6', 'spread': '2.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'body mass index', 'classes': [{'categories': [{'measurements': [{'value': '45.61', 'spread': '2.61', 'groupId': 'BG000'}, {'value': '47.72', 'spread': '2.92', 'groupId': 'BG001'}, {'value': '46.67', 'spread': '2.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms per meter squared', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '199.10', 'spread': '12.23', 'groupId': 'BG000'}, {'value': '208.70', 'spread': '11.90', 'groupId': 'BG001'}, {'value': '203.9', 'spread': '12.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '283.1', 'spread': '56.25', 'groupId': 'BG000'}, {'value': '202.40', 'spread': '43.61', 'groupId': 'BG001'}, {'value': '242.75', 'spread': '49.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'fasting insulin', 'classes': [{'categories': [{'measurements': [{'value': '54.89', 'spread': '19.55', 'groupId': 'BG000'}, {'value': '36.49', 'spread': '12.75', 'groupId': 'BG001'}, {'value': '45.69', 'spread': '16.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mIU/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'homeostatic model assessment insulin resistent', 'classes': [{'categories': [{'measurements': [{'value': '30.51', 'spread': '11.98', 'groupId': 'BG000'}, {'value': '8.50', 'spread': '3.10', 'groupId': 'BG001'}, {'value': '19.51', 'spread': '7.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The HOMA(IR) is a highly specific tool in measuring insulin resistance in patients in both diagnosis of diabetes and its treatment.\n\nHOMA IR is calculated from blood fasting insulin concentration (μU/ml) × fasting glucose concentration (mmol/L)/22.5 and must be taken at the same point in time.\n\nNormal healthy subjects have a HOMA(IR) of 1 while subjects with type 2 diabetes have elevated levels of HOMA IR. Higher levels indicate more insulin resistance and therefore a worse outcome measure.', 'unitOfMeasure': 'HOMA-IR score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'hemoglobin A 1 c', 'classes': [{'categories': [{'measurements': [{'value': '9.38', 'spread': '0.62', 'groupId': 'BG000'}, {'value': '5.52', 'spread': '0.06', 'groupId': 'BG001'}, {'value': '7.45', 'spread': '0.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'fasting glucose', 'classes': [{'categories': [{'measurements': [{'value': '207', 'spread': '17.69', 'groupId': 'BG000'}, {'value': '93.08', 'spread': '2.50', 'groupId': 'BG001'}, {'value': '150.04', 'spread': '10.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and tissue samples(adipose, omentum and liver biopsies)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2010-06-23', 'resultsFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2011-03-23', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-07', 'studyFirstPostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.', 'timeFrame': 'G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, and 12 weeks post surgery.', 'description': 'G6PD levels will be measured various time intervals. G6PD is the rate limiting enzyme of the pentose phosphate pathway that provides NADPH required for lipid synthesis. G6PD overexpression is implicated in insulin resistance, hyperlipidemia and increases in oxidative stress.'}], 'secondaryOutcomes': [{'measure': 'Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.', 'timeFrame': 'G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, and 12 weeks post surgery.', 'description': 'G6PD levels will be measured various time intervals. G6PD is the rate limiting enzyme of the pentose phosphate pathway that provides NADPH required for lipid synthesis. G6PD overexpression is implicated in insulin resistance, hyperlipidemia and increases in oxidative stress.'}, {'measure': 'Measure Omentum G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.', 'timeFrame': 'time of gastric bypass'}, {'measure': 'Measure Hepatocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.', 'timeFrame': 'time of gastric bypass'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Obesity']}, 'descriptionModule': {'briefSummary': 'This study compares the improvement of weight, fasting lipid profile (triglycerides, cholesterol, HDL, and LDL) and diabetes after gastric bypass surgery with an improvement in levels of an enzyme called glucose-6-phosphate dehydrogenase (G6PD).', 'detailedDescription': 'Same as brief summary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients will be morbidly obese and undergo Roux-en-Y Gastric bypass surgery. Both Type 2 diabetic and non-diabetic patients will be accepted into the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 19 years of age and \\<70 years of age\n* HGA1c\\<6.0%\n* fasting blood sugar less than 100mg/dL\n\nExclusion Criteria:\n\n* Taking antidiabetic medications for other indications'}, 'identificationModule': {'nctId': 'NCT01322035', 'briefTitle': 'Erythrocyte and Adipocyte G6PD Activity Levels in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of South Alabama'}, 'officialTitle': 'Erythrocyte and Adipocyte G6PD Activity Levels Correlate With Differing Degrees of Dyslipidemia, Insulin Resistance and Obesity', 'orgStudyIdInfo': {'id': '09.0027'}}, 'contactsLocationsModule': {'locations': [{'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Infirmary Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36617', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}], 'overallOfficials': [{'name': 'William O Richards, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Alabama, Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Alabama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'William Richards', 'investigatorAffiliation': 'University of South Alabama'}}}}