Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-01 @ 10:45 AM
Study NCT ID:
NCT05980858
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2023-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007662', 'term': 'Ketosis'}], 'ancestors': [{'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020155', 'term': '3-Hydroxybutyric Acid'}], 'ancestors': [{'id': 'D006885', 'term': 'Hydroxybutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D007657', 'term': 'Ketone Bodies'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2023-07-05', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GFR', 'timeFrame': 'Measured after each treatment period (day 6 and approximately day 26)', 'description': 'Change in GFR measured by Tc99m-DTPA clearance'}, {'measure': 'Renal Blood Flow (RBF)', 'timeFrame': 'Subjects are scanned after each treatment period (day 6 and approximately day 26)', 'description': 'Change in RBF determined by water based PET/CT scans'}], 'secondaryOutcomes': [{'measure': '24-hour blood pressure', 'timeFrame': 'Measured after each treatment period (day 6 and approximately day 26)', 'description': 'Change in systolic 24-hour blood pressure'}, {'measure': 'Vasoactive hormones', 'timeFrame': 'Measured after each treatment period (day 6 and approximately day 26)', 'description': 'Change in plasma levels of angiotensin II, aldosterone, renin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), copeptin'}, {'measure': 'Beta-hydroxybutyrate', 'timeFrame': 'Measured after each treatment period (day 6 and approximately day 26)', 'description': 'Change ind p-beta-hydroxybutyrate'}, {'measure': 'Renal tubular transport proteins', 'timeFrame': 'Measured after each treatment period (day 6 and approximately day 26)', 'description': 'Urine excretions of aquaporin 2 (AQP2), thiazide-sensitive sodium-chloride cotransporter (NCC) and distal epithelial sodium channel (ENaC)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney circulation', 'Kidney physiology', 'Kidney function', 'Glomerular Filtration Rate'], 'conditions': ['Ketosis', 'Ketonemia']}, 'descriptionModule': {'briefSummary': 'This is a randomized, placebo-controlled, double-blinded crossover design. Fifteen healthy subjects will be randomized to receive either ketone bodies (KE4) or placebo delivered by KetoneAid. After a period of 5-days treatment, effect variables will be measured (experiment day 1). After a washout period of 14 days, the subjects are crossed over to a similar treatment period with the other treatment. The study is terminated by measuring effect variables after the second treatment period (experiment day 2).', 'detailedDescription': 'Background: Renewed interest in ketone bodies has emerged, partly driven by the recent success of selective sodium glucose co transporter 2 (SGLT-2) inhibition in preventing cardiovascular deaths in patients with diabetes mellitus (DM) and chronic kidney disease (CKD). Effects of ketosis are of importance in order to understand the beneficial effects of SGLT-2 inhibitors and to account for the full therapeutic potential of this treatment.\n\nHypothesis: Ketosis increases renal blood flow and glomerular filtration rate (GFR).\n\nMethods: It is a randomized, placebo-controlled double-blinded cross over study. Fifteen healthy subjects will be randomized to receive either ketone bodies (KE4) or for 5 days. After a wash out period of at least 14 days, the subjects are crossed over to receive the other treatment. After each treatment period effect variables will be measured including Technetium(Tc)99m - Diethylenetriamine pentaacetate (DTPA) clearance and water based positron emission tomography computed tomography (PET/CT)\n\nPerspectives: The study has the potential to provide information regarding the therapeutic potential of treatment with ketone bodies and understanding of conditions characterized by ketosis, such as SGLT2-inhibitor treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\< 30 kg/m2\n* Safe contraception if women in childbearing age\n* Normal biochemical screening\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n* Major heart-, liver-, kidney-, lung-, neurological- or endocrine disease\n* Daily use of prescription drugs (expect for contraceptives)\n* Alcohol or drug abuse\n* Periodic fasting\n* Routinely intake of ketogenic diet'}, 'identificationModule': {'nctId': 'NCT05980858', 'acronym': 'KETO', 'briefTitle': 'Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Gødstrup Hospital'}, 'officialTitle': 'Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects', 'orgStudyIdInfo': {'id': 'TZL-2-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'KetoneAid KE4, then Placebo drink', 'description': 'For five days each subject will receive beta-hydroxybutyrate (KE4), then crossed over to receive placebo drink for 5 days.', 'interventionNames': ['Dietary Supplement: Beta-hydroxybutyrate', 'Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo drink, then KetoneAid KE4', 'description': 'For five days each subject will receive a placebo drink three times daily, then subjects are crossed over to receive beta-hydroxybutyrate (KE4).', 'interventionNames': ['Dietary Supplement: Beta-hydroxybutyrate', 'Other: Placebo']}], 'interventions': [{'name': 'Beta-hydroxybutyrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each subject receive Beta-hydroxybutyrate 300mg/kg x 3 for five days. After the treatment period effect variables will be examined.', 'armGroupLabels': ['KetoneAid KE4, then Placebo drink', 'Placebo drink, then KetoneAid KE4']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Each subject receive a placebo drink 3 x day for five days. After the treatment period effect variables will be examined.', 'armGroupLabels': ['KetoneAid KE4, then Placebo drink', 'Placebo drink, then KetoneAid KE4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7400', 'city': 'Herning', 'state': 'Jutland', 'country': 'Denmark', 'facility': 'The University Clinic of Nephrology and Hypertension', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'overallOfficials': [{'name': 'Jesper N Bech, PhD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinic in Nephrology and Hypertension'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gødstrup Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}