Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT01541735
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2012-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pantoprazole on Insulin Secretion in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077402', 'term': 'Pantoprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uiec@prodigy.net.mx', 'phone': '33 36176000', 'title': 'PhD. Manuel González Ortiz', 'phoneExt': '31494', 'organization': 'Instituto Mexicano del Seguro Social'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The intervention time was short to evaluate a total change in the primary outcome variables'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pantoprazole', 'description': 'The pantoprazole will be administered in 40mg capsules', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo of calcined magnesia, capsules', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'First Phase of Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': 'The pantoprazole will be administered in 40mg capsules'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo of calcined magnesia, capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '9.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline at 45 days. (plus or minus 3 days)', 'description': 'The hyperglycemic-hyperinsulinemic clamp technique is perform to assess the phases of insulin secretion: first, late and total insulin secretion.', 'unitOfMeasure': 'µU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was determined per protocol and sample size was calculated whit the formula for clinical trial'}, {'type': 'SECONDARY', 'title': 'Glycated Hemoglobin A1C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': 'The pantoprazole will be administered in 40mg capsules'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo of calcined magnesia, capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '.38', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline in glycated hemoglobin A1C at 45 day.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Second Phase of Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': 'The pantoprazole will be administered in 40mg capsules'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo of calcined magnesia, capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '35.9', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '38.4', 'spread': '30.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 45 day', 'description': 'Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days)', 'unitOfMeasure': 'µU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': 'The pantoprazole will be administered in 40mg capsules'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo of calcined magnesia, capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '31.5', 'spread': '23.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline of total insulin secretion at 45 day (plus or minus 3 days)', 'description': 'The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion', 'unitOfMeasure': 'µU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pantoprazole', 'description': 'The pantoprazole will be administered in 40mg capsules PO, 30 minutes before to breakfast during 45 days'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo of calcined magnesia, capsules PO, 30 minutes before to breakfast during 45 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pantoprazole', 'description': 'The pantoprazole will be administered in 40mg capsules'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo of calcined magnesia, capsules'}, {'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': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '46.2', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '48.0', 'spread': '8.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-07', 'studyFirstSubmitDate': '2012-02-20', 'resultsFirstSubmitDate': '2013-07-27', 'studyFirstSubmitQcDate': '2012-02-24', 'lastUpdatePostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-07', 'studyFirstPostDateStruct': {'date': '2012-03-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First Phase of Insulin Secretion', 'timeFrame': 'Change from Baseline at 45 days. (plus or minus 3 days)', 'description': 'The hyperglycemic-hyperinsulinemic clamp technique is perform to assess the phases of insulin secretion: first, late and total insulin secretion.'}, {'measure': 'Second Phase of Insulin Secretion', 'timeFrame': 'Baseline and 45 day', 'description': 'Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days)'}, {'measure': 'Total Insulin Secretion', 'timeFrame': 'Change from baseline of total insulin secretion at 45 day (plus or minus 3 days)', 'description': 'The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion'}], 'secondaryOutcomes': [{'measure': 'Glycated Hemoglobin A1C', 'timeFrame': 'Change from Baseline in glycated hemoglobin A1C at 45 day.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Insulin', 'Pantoprazole'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '25704601', 'type': 'DERIVED', 'citation': 'Gonzalez-Ortiz M, Martinez-Abundis E, Mercado-Sesma AR, Alvarez-Carrillo R. Effect of pantoprazole on insulin secretion in drug-naive patients with type 2 diabetes. Diabetes Res Clin Pract. 2015 Apr;108(1):e11-3. doi: 10.1016/j.diabres.2015.01.039. Epub 2015 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effect of pantoprazole on insulin secretion in drug-naïve patients with type 2 diabetes.', 'detailedDescription': 'Type 2 diabetes mellitus (T2DM) has become a major health problem worldwide with a high prevalence and related mortality, and a high rate of disability in the economically active. In Mexico the prevalence was 14.4% reported one of the highest in Latin America and estimated a cost of $ 778 million allocated for this disease in 2010, i.e., the tenth place worldwide. Within its pathophysiology are alterations in the secretion and insulin action, qualitatively and quantitatively, which implies a challenge for long-term metabolic control with the pharmacological arsenal available today. Since the function of pancreatic β cell decreases as a function of time and lack of control is essential metabolic find drugs that can preserve pancreatic cell mass and even promote neogenesis, with the aim of restoring the physiological secretion of insulin have been lost in the early stages of type 2 diabetes to achieve optimal glycemic control sustained over time to avoid complications and reduce the costs associated with the disease.\n\nHave been evaluated in animal models with promising results Proton Pumps Inhibitors (PPI) for the restoration of glucose and the preservation of pancreatic cell function, including promoting its growth through increased levels of gastrin, which appears to act as a growth factor. However, at present no such mechanisms have been evaluated in humans, it would be interesting to assess the effect of administration of a PPI such as pantoprazole is, on the phases of insulin secretion in patients with T2DM recent diagnosis.\n\nMaterial and Methods: Randomized, double-blind, placebo controlled clinical trial. Population: 14 drug-naive adults patients with T2DM and obesity. Hyperglycemic-hyperinsulinemic clamp to assess the phases of insulin secretion. Intervention for 45 days: pantoprazole 40mg or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus\n* Drug-Naive\n* No complications\n* HbA1c 7 to \\< 9%\n* Fasting plasma glucose \\< 210mg/dl\n* Body mass index 30.0 to 39.9 and body weight stable for at least 3 months before the study\n* Non smokers\n* Blood pressure \\< 130/80\n\nExclusion Criteria:\n\n* Diabetes complications\n* Women pregnant or stage of lactation\n* Hepatic, renal, autoimmune disease\n* Take drugs with effects on insulin secretion\n* Zollinger-Ellison disease\n* Gastric or pancreatic tumor.'}, 'identificationModule': {'nctId': 'NCT01541735', 'acronym': 'IBP', 'briefTitle': 'Pantoprazole on Insulin Secretion in Diabetes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Coordinación de Investigación en Salud, Mexico'}, 'officialTitle': 'Effect of Pantoprazole on Insulin Secretion in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'IBP1301-93'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo of calcined magnesia, capsules', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Pantoprazole', 'description': 'The pantoprazole will be administered in 40mg capsules', 'interventionNames': ['Drug: Pantoprazole']}], 'interventions': [{'name': 'Pantoprazole', 'type': 'DRUG', 'otherNames': ['Pantozol'], 'description': 'The pantoprazole will be administered in capsules of 40mg. The dose will be 1 capsule per day during 45 days.', 'armGroupLabels': ['Pantoprazole']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo 40 mg dose.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44380', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Instituto Mexicano del Seguro Social. Hospital de Especialidades.', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'Manuel Gonzalez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Mexicano del Seguro Social. Centro Medico Nacional de Occidente. Unidad de Investigación Médica en Epidemiologia Clínica'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coordinación de Investigación en Salud, Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Manuel Gonzalez Ortiz', 'investigatorAffiliation': 'Coordinación de Investigación en Salud, Mexico'}}}}