Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-28 @ 10:05 AM
Study NCT ID:
NCT05530356
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2022-11-02
First Post:
2022-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], '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': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010130', 'term': 'p-Aminohippuric Acid'}, {'id': 'D007472', 'term': 'Iohexol'}, {'id': 'D003911', 'term': 'Dextrans'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D000618', 'term': 'Aminohippuric Acids'}, {'id': 'D006626', 'term': 'Hippurates'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D007651', 'term': 'Keto Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D014283', 'term': 'Triiodobenzoic Acids'}, {'id': 'D007463', 'term': 'Iodobenzoates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Samples to be retained will include urine, plasma, and serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective Renal Plasma Flow (ERPF)', 'timeFrame': '4 Hours', 'description': 'Measured by PAH clearance'}, {'measure': 'Glomerular Filtration Rate', 'timeFrame': '4 Hours', 'description': 'Measured by Iohexol Clearance'}, {'measure': 'Glomerular Size Selectivity', 'timeFrame': '4 hours', 'description': 'Measured by Dextran sieving'}, {'measure': 'Renal Oxygen Availability', 'timeFrame': '1 hour', 'description': 'Measured by functional kidney MRI'}, {'measure': 'Renal Perfusion', 'timeFrame': '1 hour', 'description': 'Measured by functional kidney MRI + PET Scan'}, {'measure': '11-C Acetate Tracer Uptake', 'timeFrame': '1 Hour', 'description': 'Measured by PET Scan'}, {'measure': 'Renal Oxidative Metabolism', 'timeFrame': '1 Hour', 'description': 'Measured by PET Scan'}, {'measure': 'Blood Volume Fraction', 'timeFrame': '1 Hour', 'description': 'Measured by PET Scan'}, {'measure': 'Glomerular Basement Membrane Width', 'timeFrame': '1 Hour', 'description': 'Measured by Renal Biopsy'}, {'measure': 'Mesangial Expansion', 'timeFrame': '1 Hour', 'description': 'Measured by Renal Biopsy'}, {'measure': 'Interstitial Fibrosis', 'timeFrame': '1 Hour', 'description': 'Measured by Renal Biopsy'}, {'measure': 'Renal Arteriosclerosis', 'timeFrame': '1 Hour', 'description': 'Measured by Renal Biopsy'}, {'measure': 'Spatial Transcriptomics', 'timeFrame': '1 Hour', 'description': 'Measured by Renal Biopsy'}, {'measure': 'Spatial Metabolomics', 'timeFrame': '1 Hour', 'description': 'Measured by Renal Biopsy'}], 'secondaryOutcomes': [{'measure': 'Pulse Wave Velocity between Carotid and Femoral Artery', 'timeFrame': '10 minutes', 'description': 'Measured by PWV'}, {'measure': 'Whole brain gray matter volume', 'timeFrame': '1 Hour', 'description': 'Measured by brain MRI'}, {'measure': 'Whole brain cortical thickness', 'timeFrame': '1 Hour', 'description': 'Measured by brain MRI'}, {'measure': 'Whole brain resting-state network connectivity', 'timeFrame': '1 Hour', 'description': 'Measured by brain MRI'}, {'measure': 'Age-corrected composite fluid cognition score', 'timeFrame': '1 Hour', 'description': 'Measured by brain MRI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Diabetes Type 2', 'Diabetic Nephropathies', 'Nephropathy', 'Obesity', 'Adolescent Obesity', 'Diabetic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The current protocol plans to enroll participants with youth-onset Type 2 Diabetes (T2D) as well as obese and lean controls from the Renal-HEIR - Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study (n=100) \\[COMIRB #16-1752\\] in a prospective investigation that seeks to 1) define the changes in kidney function by gold standard techniques and energetics by functional Magnetic Resonance Imaging (MRI) in adolescents with and without T2D as they transition to young adulthood; 2) quantify kidney oxidative metabolism by 11C-acetate Positron Emission Tomography (PET) in a subset of participants who are ≥18 years of age with youth-onset T2D and/or obesity; 3) determine peripheral arterial stiffness by SphygmoCor. Mechanistic insight will be provided by transcriptomic analyses of repeat biopsies 3-years after their initial biopsy for eligible participants with youth-onset T2D, as well as molecular analysis of tissue obtained from J-wire endovascular biopsies. This study will also leverage this well-characterized cohort of youths to define youth-onset T2D-related changes in brain morphology and function by structural MRI and resting-state functional MRI and through the assessment of cognitive function (fluid and crystallized intelligence) using the NIH Toolbox Cognitive Battery (NIHTB-CB), as an exploratory objective. All enrollees in Renal-HEIR have consented to be contacted for future research opportunities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '26 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population to be enrolled will be comprised of obese youth with and without T2D and lean controls who were previously enrolled in the Renal-HEIR (#16-1752) study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese youth with and without Type 2 Diabetes + lean controls who were previously enrolled in the Renal HEIR Study\n* Participants who will undergo a PET Scan: ≥ 18 years\n\nExclusion Criteria:\n\n* Anemia\n* Seafood, iodine, or penicillin allergy\n* Pregnancy\n* MRI Scanning contraindications (claustrophobia, implantable devices, \\>550 lbs)\n* History of bleeding or clotting disorders, thrombocytopenia, warfarin and/or heparin use\n* Taking sulfonamides, procaine, thiazolsulfone or probenecid'}, 'identificationModule': {'nctId': 'NCT05530356', 'acronym': 'HEIRitage', 'briefTitle': 'Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes: A Follow-up Study', 'orgStudyIdInfo': {'id': '20-2961'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lean Controls (previously enrolled in the Renal HEIR Study)', 'interventionNames': ['Drug: Aminohippurate Sodium Inj 20%', 'Drug: Iohexol Inj 300 MG/ML', 'Drug: Dextran 40']}, {'label': 'Obese Youth without Type 2 Diabetes (previously enrolled in the Renal HEIR Study)', 'interventionNames': ['Drug: Aminohippurate Sodium Inj 20%', 'Drug: Iohexol Inj 300 MG/ML', 'Drug: Dextran 40', 'Radiation: Positron Emission Tomography']}, {'label': 'Obese Youth with Type 2 Diabetes (previously enrolled in the Renal HEIR Study)', 'interventionNames': ['Drug: Aminohippurate Sodium Inj 20%', 'Drug: Iohexol Inj 300 MG/ML', 'Drug: Dextran 40', 'Procedure: Renal Biopsy', 'Radiation: Positron Emission Tomography']}], 'interventions': [{'name': 'Aminohippurate Sodium Inj 20%', 'type': 'DRUG', 'otherNames': ['Sodium 4-amino hippurate (PAH) inj 20% 2g/10mL', 'Para-aminohippurate', 'Aminohippuric acid'], 'description': 'Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)', 'armGroupLabels': ['Lean Controls (previously enrolled in the Renal HEIR Study)', 'Obese Youth with Type 2 Diabetes (previously enrolled in the Renal HEIR Study)', 'Obese Youth without Type 2 Diabetes (previously enrolled in the Renal HEIR Study)']}, {'name': 'Iohexol Inj 300 MG/ML', 'type': 'DRUG', 'otherNames': ['omnipaque 300'], 'description': 'Diagnostic aid/agent used to measure glomerular filtration rate (GFR)', 'armGroupLabels': ['Lean Controls (previously enrolled in the Renal HEIR Study)', 'Obese Youth with Type 2 Diabetes (previously enrolled in the Renal HEIR Study)', 'Obese Youth without Type 2 Diabetes (previously enrolled in the Renal HEIR Study)']}, {'name': 'Dextran 40', 'type': 'DRUG', 'otherNames': ['Dextran', 'LMD'], 'description': 'Diagnostic aid/agent used to measure glomerular size selectivity', 'armGroupLabels': ['Lean Controls (previously enrolled in the Renal HEIR Study)', 'Obese Youth with Type 2 Diabetes (previously enrolled in the Renal HEIR Study)', 'Obese Youth without Type 2 Diabetes (previously enrolled in the Renal HEIR Study)']}, {'name': 'Renal Biopsy', 'type': 'PROCEDURE', 'otherNames': ['Kidney Biopsy'], 'description': 'Minimally invasive outpatient procedure in interventional radiology to obtain renal tissue cores.', 'armGroupLabels': ['Obese Youth with Type 2 Diabetes (previously enrolled in the Renal HEIR Study)']}, {'name': 'Positron Emission Tomography', 'type': 'RADIATION', 'otherNames': ['PET Scan'], 'description': 'Imaging study performed to study renal oxidative metabolism', 'armGroupLabels': ['Obese Youth with Type 2 Diabetes (previously enrolled in the Renal HEIR Study)', 'Obese Youth without Type 2 Diabetes (previously enrolled in the Renal HEIR Study)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Petter Bjornstad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Colorado"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}