Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2026-03-14 @ 4:58 PM
Study NCT ID:
NCT04401904
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2020-04-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SGLT2 Inhibition in Older Obese Adults With Pre-diabetes
Sponsor:
Organization:
Raw JSON
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Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'solisherrera@uthscsa.edu', 'phone': '210-567-4900', 'title': 'Carolina Solis-Herrera, MD', 'organization': 'UT Health San Antonio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 Months', 'eventGroups': [{'id': 'EG000', 'title': 'Dapagliflozin', 'description': '10 participants with pre-diabetes will be randomized to the experimental group to receive dapagliflozin 10mg by mouth daily for 12 weeks.\n\nDapagliflozin 10 mg: 10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 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'title': 'Nutritional Counseling', 'description': '10 participants with pre-diabetes will be randomized to receive nutritional counseling weekly for 12 weeks\n\nNutritional counseling: 10 participants randomized to receive 12 weeks of weekly counseling on nutrition'}], 'classes': [{'categories': [{'measurements': [{'value': '-172', 'spread': '121', 'groupId': 'OG000'}, {'value': '-86', 'spread': '112', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in AGE-RAGE measured by enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Grip Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': '10 participants with pre-diabetes will be randomized to the experimental group to 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'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': '10 participants with pre-diabetes will be randomized to the experimental group to receive dapagliflozin 10mg by mouth daily for 12 weeks.\n\nDapagliflozin 10 mg: 10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth'}, {'id': 'OG001', 'title': 'Nutritional Counseling', 'description': '10 participants with pre-diabetes will be randomized to receive nutritional counseling weekly for 12 weeks\n\nNutritional counseling: 10 participants randomized to receive 12 weeks of weekly counseling on nutrition'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '11.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in walking distance in the 6 minute walking test.', 'unitOfMeasure': 'm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dapagliflozin', 'description': '10 participants with pre-diabetes will be randomized to the experimental group to receive dapagliflozin 10mg by mouth daily for 12 weeks.\n\nDapagliflozin 10 mg: 10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth'}, {'id': 'FG001', 'title': 'Nutritional Counseling', 'description': '10 participants with pre-diabetes will be randomized to receive nutritional counseling weekly for 12 weeks\n\nNutritional counseling: 10 participants randomized to receive 12 weeks of weekly counseling on nutrition'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dapagliflozin', 'description': '10 participants with pre-diabetes will be randomized to the experimental group to receive dapagliflozin 10mg by mouth daily for 12 weeks.\n\nDapagliflozin 10 mg: 10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth'}, {'id': 'BG001', 'title': 'Nutritional Counseling', 'description': '10 participants with pre-diabetes will be randomized to receive nutritional counseling weekly for 12 weeks\n\nNutritional counseling: 10 participants randomized to receive 12 weeks of weekly counseling on nutrition'}, {'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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', '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': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-30', 'size': 1088139, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-17T14:48', 'hasProtocol': True}, {'date': '2021-09-22', 'size': 741552, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-07-17T14:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '20 completed subjects are planned. Each subject will be randomized to either the experimental group of dapagliflozin 10mg daily for 12 weeks or the control group of nutritional counseling for weight loss.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2020-04-22', 'resultsFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2020-05-20', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-04', 'studyFirstPostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AGE-RAGE Measurement in Plasma', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in AGE-RAGE measured by enzyme-linked immunosorbent assay (ELISA).'}], 'secondaryOutcomes': [{'measure': 'Grip Strength', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in grip strength measured using a hand-held dynamometer in Newton meters (Nm)'}, {'measure': '6 Minute Walking Distance', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in walking distance in the 6 minute walking test.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pre-diabetes', 'aging', 'glucose metabolism', 'borderline diabetes'], 'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'Inhibitors of the sodium-glucose co-transporter (SGLT2) are FDA-approved for the treatment of type 2 diabetes (T2DM). Their mechanism of action involves lowering of blood glucose concentration secondary to increased glucose excretion of glucose by the kidney. These drugs also improve body weight, blood pressure, and cardiac function. Based on these pleiotropic effects, including its calorie restriction-mimetic properties, the study team hypothesize that SGLT2 drugs will impact several basic aging-related processes, including reductions in oxidative damage to DNA and proteins, advanced glycation end products (AGE) and receptor for AGE (RAGE), cellular senescence, and mitochondrial function.', 'detailedDescription': 'Investigations into the aging process have identified major cellular dysfunctions that contribute to aging, including but not limited to increased burden of damaged DNA and protein, reduction in mitochondrial respiration, and the development of pro-inflammatory senescent cells. Developing and testing interventions that interact with multiple points of this spectrum may delay the aging process. Based on prior investigations, the study team believe the SGLT2 inhibitor class of drugs may target these basic mechanisms involved in the aging process and propose testing in a high-risk human population to evaluate their effectiveness in ameliorating aging-associated dysfunctions. Specifically, the investigators hypothesize that SGLT2i drugs will lead to reductions in oxidative damage to DNA and proteins, AGE-RAGE, and cellular senescence, which will be accompanied by improvements in mitochondrial function. If the hypothesis is correct, these findings could lead to the development of new approaches to increase both health-span and lifespan.\n\nThis is a single center, open-label, randomized controlled trial. The target enrollment for this pilot study is 20 completed subjects, split evenly between experimental and control groups. Each subject will be randomized to either the experimental group of dapagliflozin 10mg daily for 12 weeks or the control group of nutritional counseling for weight loss. Health-span and clinical evaluations will be taken at baseline and at weeks 10-12 of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men or post-menopausal women.\n2. Age= 60+ years.\n3. All ethnic groups.\n4. Body Mass index (BMI) between 30-38 kg/m2.\n5. Diagnosis of pre-diabetes (HbA1c 5.7-6.4% and 2 hr. Oral Glucose Tolerance Test (OGTT) glucose between 140-199 mg/dL, evaluated at Visit 1 and 2).\n6. Stable body weight (±3% for ≥3 months).\n7. Willing to adhere to medication regimen for three months.\n8. Montreal Cognitive Assessment score ≥21\n\nExclusion Criteria:\n\n1. Diagnosis of diabetes based on American Diabetes Association (ADA) criteria\n2. Impaired renal function with estimated Glomerular Filtration Rate (eGFR) \\< 45 mL/min/1.73m2 .\n3. Impaired liver function with labs ≥3 times upper limits of normal range\n4. Abnormal hematocrit with lower limits of ≤30%\n5. Abnormal triglycerides with upper limits ≥600 mg/dL\n6. Abnormal Thyroid stimulating hormone (TSH) values ≤0.3 and ≥10\n7. Urinalysis results with ˃ 5-10 white blood cell count\n8. Concomitant medications known to affect glucose and lipid homeostasis (anti-diabetes medications, glucocorticoids, atypical antipsychotics, anti-transplant rejection medications, anti-retrovirals).\n9. Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies.\n10. History of recent cardiovascular event in the last 6 months or Heart Failure (New York Heart Classification greater than class III-IV; recent EKG changes that suggest active heart disease\n11. Poorly controlled blood pressure (systolic BP\\>180, diastolic BP\\>100 mmHg).\n12. Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and uncontrolled psychiatric disease (Subjects with depression, anxiety, PTSD, etc. can enroll if controlled and on stable medication)\n13. Blood donation within 2 months prior to enrollment\n14. History of frequent UTI'}, 'identificationModule': {'nctId': 'NCT04401904', 'acronym': 'SGLT2i', 'briefTitle': 'SGLT2 Inhibition in Older Obese Adults With Pre-diabetes', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Effect of SGLT2 Inhibition on Aging-related Biomarkers in Older Obese Adults With Pre-diabetes', 'orgStudyIdInfo': {'id': 'HSC20190766H'}, 'secondaryIdInfos': [{'id': '2P30AG044271', 'link': 'https://reporter.nih.gov/quickSearch/2P30AG044271', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin', 'description': '10 participants with pre-diabetes will be randomized to the experimental group to receive dapagliflozin 10mg by mouth daily for 12 weeks.', 'interventionNames': ['Drug: Dapagliflozin 10 mg']}, {'type': 'OTHER', 'label': 'Nutritional Counseling', 'description': '10 participants with pre-diabetes will be randomized to receive nutritional counseling weekly for 12 weeks', 'interventionNames': ['Behavioral: Nutritional counseling']}], 'interventions': [{'name': 'Dapagliflozin 10 mg', 'type': 'DRUG', 'otherNames': ['Farxiga'], 'description': '10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth', 'armGroupLabels': ['Dapagliflozin']}, {'name': 'Nutritional counseling', 'type': 'BEHAVIORAL', 'description': '10 participants randomized to receive 12 weeks of weekly counseling on nutrition', 'armGroupLabels': ['Nutritional Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Diabetes Institute - University Health System', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Carolina Solis-Herrera', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Health at San Antonio'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'After study completion, upon publication of data and on ClinicalTrials.gov 1 year after primary completion date of study.', 'ipdSharing': 'YES', 'description': 'Protocol, Statistical Analysis Plan, Published data', 'accessCriteria': 'Data will be analysed by a statistician for publication and by direct communication with the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}