Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-31 @ 12:25 PM
Study NCT ID:
NCT06846034
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D000860', 'term': 'Hypoxia'}], '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': 'D007674', 'term': 'Kidney 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': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'It is a descriptive, prospective, open label, single centre, pilot study.\n\nThis research aim to better understand the effect of hypoxia on intrarenal hemodynamic parameters of 3 groups :\n\nGroup 1: Healthy volunteers Group 2: Patient with Type 2 Diabetes (DT2) without Diabetic Kidney Disease (DKD) Group 3: Patient with T2D and DKD'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-20', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Renal Oxygenation Availability', 'timeFrame': '60 minutes', 'description': 'Blood oxygen level dependent (BOLD) MRI'}, {'measure': 'Cardiac Oxygenation Availability', 'timeFrame': '60 minutes', 'description': 'Blood oxygen level dependent (BOLD) MRI'}], 'primaryOutcomes': [{'measure': 'Effective Renal Plasma Flow (ERPF)', 'timeFrame': '5 hours', 'description': 'Measured by PAH clearance'}, {'measure': 'Glomerular Filtration Rate', 'timeFrame': '5 hours', 'description': 'Measured by Iohexol Clearance'}], 'secondaryOutcomes': [{'measure': 'circulating and urinary mitochondrial metabolites', 'timeFrame': '8 days', 'description': 'To investigate change of blood or urine metabolites : 2-ethyl 3-OH propionate, 3-hydroxy propionate, 3-hydroxy isovalerate, 3-methyl-crotonyl glycine, 3-hydroxy isobutyrate, Tiglyglycine, Aconitic acid, Citric acid, Glycolic acid, Homovanillic acid, Uracil, 3-methyl adipic acid.'}, {'measure': 'blood pressure', 'timeFrame': '5 hours', 'description': 'mean arterial pressure'}, {'measure': 'heart rate', 'timeFrame': '5 hours', 'description': 'heart rate'}, {'measure': 'Lake Louise Questionnaire', 'timeFrame': '5 hours', 'description': 'The Lake Louise Scoring was developed to assess the symptoms of acute mountain sickness in adults. It consist of 4 questions, each rated on a likert-type scale with 0-3 response options. Lower scores men a better outcome.'}, {'measure': 'Oxygen saturation', 'timeFrame': '5 hours', 'description': 'SpO2'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetic Kidney Disease', 'Hypoxia', 'Healthy Volunteer', 'Diabetic Nephropathies']}, 'descriptionModule': {'briefSummary': 'Diabetes mellitus is a non-transmissible disease whose incidence is growing worldwide .\n\nThis pathology is defined by a chronic hyperglycaemia linked to a deficiency of either insulin secretion or its action or both. This increased prevalence is linked to the growing of the obese population on one hand, and to the ageing of the population, on the other hand, which is associated with an increased prevalence of metabolic diseases. The number of patients with diabetes, particularly type 2 diabetes (T2D) is regularly increasing. In France, the prevalence of diabetes is 4- 6% of the adult population.\n\nDiabetic kidney disease (DKD) is a growing public health problem and therefore constitutes a major factor in progressive kidney disease. DKD has become the leading cause of end stage kidney disease (ESKD), requiring dialysis or transplantation.\n\nCurrent routine screening for DKD is limited to detecting of impaired glomerular filtration rate (GFR) and/or elevated albuminuria, typically manifests in later stages of DKD. Therefore, the current methods to screen for DKD lack the resolution to capture the earliest functional changes associated with DKD.\n\nChronic renal hypoxia plays a crucial role in the development and progression of DKD and may affect Renal hemodynamic.\n\nThe aim to assess the feasibility of the measure of hypoxa-induced renal hemodynamics parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor all participant :\n\n1. No history of respiratory diseases\n2. Affiliated person or beneficiary of the French social security scheme.\n3. signed informed consent\n\nGroup 1 ( For healthy volunteers):\n\n1. \\[18; 40\\] years old\n2. No history of diabetes\n3. No acute/long term \\> 3 months drug use except contraception\n4. BMI: \\[18,5 - 29,9\\]kg/m2\n5. eGFR \\> 60ml/min/1.73m2\n6. Normal to midly increased albuminuria: defined as ACR \\< 3 mg/mmol\n\nFor all the patients with T2D (group 2 and 3):\n\n1. Diagnosed T2D according to ADA criteria\n2. \\[35; 75\\] years old\n3. Stable treatment of diabetes and/or antihypertension for at least 2 months prior to inclusion\n4. No proliferative diabetic retinopathy\n\nGroup 2 - For patients with T2D and no DKD:\n\n* eGFR \\> 60ml/min/1.73m2 and\n* Normal to midly increased albuminuria: defined as ACR \\< 3 mg/mmol\n\nGroup 3 - For patients with DKD:\n\n* eGFR \\[45-60 ml/min/1.73m2\\] and/or\n* Moderately to severely increased ACR ≥ 3 mg/mmol\n\nExclusion Criteria:\n\nFor all participants:\n\n1. Active smoking\n2. Contraindication to any of the agent (PAH, or iohexol or gadolinium) used in the study.\n3. Contraindication to cardiac MRI, renal MRI, respiratory tests,\n4. History acute coronary syndrome or coronary revascularization\n5. Recent (\\<6 months) history of: Heart failure requiring hospitalisation or Stroke or transient ischemic neurologic disorder\n6. Severe unstable hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure)\n7. Resting oxygen saturation \\<95% at baseline\n8. Any concomitant disease or condition that may interfere with the safety or the possibility for the patient to comply with or complete the study protocol.\n9. History of severe mountain sickness (dizziness, headache, nausea/vomiting and incapaciting fatigue)\n10. Consumption of SGLT2 inhibitors\n11. Concurrent participation in another clinical research study\n12. Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception\n13. Persons benefiting from enhanced protection under french national law\n14. Persons under psychiatric care who are unable to give their consent'}, 'identificationModule': {'nctId': 'NCT06846034', 'acronym': 'DIAKIPOX', 'briefTitle': 'Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease : Pilot Study.', 'orgStudyIdInfo': {'id': 'DIAKIPOX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'acute hypoxia', 'description': 'The participant will be exposed to 2 sequences : a 3-hour normoxia period and then a 2-hour hypoxia (FiO2=14.26% corresponding to 3000m altitude) period.', 'interventionNames': ['Other: Hypoxia administration study group', 'Combination Product: Renal clairance study']}], 'interventions': [{'name': 'Hypoxia administration study group', 'type': 'OTHER', 'description': 'Acute 2-hour hypoxia (14.5%FiO2 corresponding to 3000m altitude)', 'armGroupLabels': ['acute hypoxia']}, {'name': 'Renal clairance study', 'type': 'COMBINATION_PRODUCT', 'description': 'Assessment of renal clearance by measuring Glomerular Filtration Rate (GFR) after two agents infusion:\n\n* Aminohippurate Sodium (or or para-aminohippuric acid \\[PAH\\]) Inj 20% Diagnostic agent used to measure effective renal plasma flow (ERPF)\n* Iohexol Inj 300 MG/ML Diagnostic agent used to measure glomerular filtration rate (GFR)', 'armGroupLabels': ['acute hypoxia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie RABOIS, MSc', 'role': 'CONTACT', 'email': 'emilie.rabois@chu-poitiers.fr', 'phone': '+33(0)549444689'}, {'name': 'Pierre Jean SAULNIER, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christophe RAULT, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Investigation Clinique CIC1402 - CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'centralContacts': [{'name': 'Emilie RABOIS, MSc', 'role': 'CONTACT', 'email': 'emilie.rabois@chu-poitiers.fr', 'phone': '+330549444686'}, {'name': 'Céline DELETAGE METREAU, PhD', 'role': 'CONTACT', 'email': 'Celine.DELETAGE-METREAU@chu-poitiers.fr'}], 'overallOfficials': [{'name': 'Pierre Jean SAULNIER, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Poitiers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}