Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-02-26 @ 12:21 AM
Study NCT ID:
NCT04194450
Status:
COMPLETED
Last Update Posted:
2025-05-30
First Post:
2019-12-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exogenous Ketones in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007662', 'term': 'Ketosis'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jonathan.little@ubc.ca', 'phone': '(250) 807-9876', 'title': 'Dr. Jonathan Little', 'organization': 'University of British Columbia'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'About two weeks. Timeframe of first visit and second visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Overall', 'description': 'Total participants independent of crossover order (Placebo-Ketones and Ketones-Placebo).', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '6.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': '60 minutes', 'categories': [{'measurements': [{'value': '6.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': '90 minutes', 'categories': [{'measurements': [{'value': '6.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': '120 minutes', 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '150 minutes', 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': '180 minutes', 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes', 'description': 'Plasma glucose concentration after ketone or placebo ingestion', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '26.7', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '18.2', 'groupId': 'OG001'}]}]}, {'title': '180minutes', 'categories': [{'measurements': [{'value': '24.3', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '21.4', 'spread': '15.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes', 'description': 'Insulin across concentration after ketone or placebo ingestion', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma C-peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '4,384', 'spread': '2,155', 'groupId': 'OG000'}, {'value': '4,438', 'spread': '2,241', 'groupId': 'OG001'}]}]}, {'title': '180 minutes', 'categories': [{'measurements': [{'value': '3,908', 'spread': '1,859', 'groupId': 'OG000'}, {'value': '3,918', 'spread': '2,232', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes', 'description': 'C-peptide across concentration after ketone or placebo ingestion', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Free Fatty Acids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': '180 minutes', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes', 'description': 'Non-esterified fatty acid concentration after ketone or placebo ingestion', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Tumour Necrosis Factor Alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': '180min', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes', 'description': 'Plasma tumour necrosis factor alpha concentration after ketone or placebo ingestion', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Tumour Interleukin-1beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '253', 'spread': '450', 'groupId': 'OG000'}, {'value': '115', 'spread': '74', 'groupId': 'OG001'}]}]}, {'title': '180min', 'categories': [{'measurements': [{'value': '106', 'spread': '105', 'groupId': 'OG000'}, {'value': '102', 'spread': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes', 'description': 'Plasma tumour interleukin-1beta concentration after ketone or placebo ingestion', 'unitOfMeasure': 'fg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Tumour Interleukin-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '180min', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes', 'description': 'Plasma tumour interleukin-6 concentration after ketone or placebo ingestion', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cerebral Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'timeFrame': '180 minutes', 'description': 'Intracranial blood flow velocity measured by ultrasound', 'reportingStatus': 'POSTED', 'populationDescription': 'Procedure not completed due to the unavailability of a specialized research staff. Data was not and will not be obtained and reported.'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'title': 'Systolic blood pressure baseline', 'categories': [{'measurements': [{'value': '133', 'spread': '18', 'groupId': 'OG000'}, {'value': '130', 'spread': '16', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure 180min', 'categories': [{'measurements': [{'value': '139', 'spread': '19', 'groupId': 'OG000'}, {'value': '136', 'spread': '18', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure baseline', 'categories': [{'measurements': [{'value': '79', 'spread': '7', 'groupId': 'OG000'}, {'value': '77', 'spread': '10', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure 180min', 'categories': [{'measurements': [{'value': '83', 'spread': '11', 'groupId': 'OG000'}, {'value': '78', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes', 'description': 'Blood pressure measured manually and by Finipres', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cognitive Function - Digital Symbol Substitution Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'title': 'baseline Digit-symbol substitution task', 'categories': [{'measurements': [{'value': '32.8', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '32.4', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': '180min Digit-symbol substitution task', 'categories': [{'measurements': [{'value': '35.7', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '34.5', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes', 'description': 'Number of Correct Answers on the Digital Symbol Substitution Task. Measure of cognitive function using Brain Baseline battery on an iPad.', 'unitOfMeasure': 'number correct', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brain-derived Neurotrophic Factor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '7.1', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': '180 minutes', 'categories': [{'measurements': [{'value': '4.8', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '9.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes', 'description': 'Brain-derived neurotrophic factor concentrations after ketone or placebo ingestion', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number Blood Monocytes (x10^3 Cells/uL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'title': 'baseline Monocytes', 'categories': [{'measurements': [{'value': '408', 'spread': '171', 'groupId': 'OG000'}, {'value': '442', 'spread': '152', 'groupId': 'OG001'}]}]}, {'title': '180min Monocytes', 'categories': [{'measurements': [{'value': '445', 'spread': '181', 'groupId': 'OG000'}, {'value': '447', 'spread': '179', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes', 'description': 'Total blood monocytes count (x10\\^3 cells/uL) after ketone or placebo ingestion', 'unitOfMeasure': 'x10^3 cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self Reported Hunger and Fullness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'title': 'baseline how hungry', 'categories': [{'measurements': [{'value': '46', 'spread': '26', 'groupId': 'OG000'}, {'value': '42', 'spread': '31', 'groupId': 'OG001'}]}]}, {'title': '180 minutes how hungry', 'categories': [{'measurements': [{'value': '58', 'spread': '21', 'groupId': 'OG000'}, {'value': '60', 'spread': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes', 'description': 'Self reported hunger and fullness by a 0 to 100 mm Visual Analog Scale (higher scores mean greater hunger or fullness)', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'title': 'nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '59'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '22'}]}]}, {'title': 'urge to vomit', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '32'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '69'}]}]}, {'title': 'bloating', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '42'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '24'}]}]}, {'title': 'belching', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '46'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '59'}]}]}, {'title': 'cramping', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '180 minutes', 'description': 'Gastrointestinal symptom questionnaire scores after ketone or placebo ingestion on a 0 to 100 mm Visual Analog Scale (higher scores mean greater symptoms)', 'unitOfMeasure': 'mm', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Energy Consumed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'classes': [{'categories': [{'measurements': [{'value': '823', 'spread': '377', 'groupId': 'OG000'}, {'value': '948', 'spread': '455', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes after ketone or placebo ingestion', 'description': 'Total energy consumed in kilocalories in buffet style meal after ketone or placebo ingestion', 'unitOfMeasure': 'kcal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Monocyte Histone Acetylation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)\n\nKetone monoester: Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.\n\nPlacebo: Acute ingestion of taste-matched placebo prior to assessment of outcomes.'}], 'timeFrame': '180 minutes', 'description': 'Histone acetylation status of monocytes measured after ketone or placebo ingestion', 'reportingStatus': 'POSTED', 'populationDescription': 'This assay was not performed due to insufficient sample quantity.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo-Ketones', 'description': 'Crossover design: Placebo - washout period of \\>2days - Ketones'}, {'id': 'FG001', 'title': 'Ketones-Placebo', 'description': 'Crossover design: Ketones - washout period of \\>2days - Placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'not eligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'Total participants independent of crossover order (Placebo-Ketones and Ketones-Placebo).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-02', 'size': 385548, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-14T15:18', 'hasProtocol': True}, {'date': '2022-04-02', 'size': 186958, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-14T15:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Placebo masked with flavouring and participants consume in opaque containers.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2019-12-09', 'resultsFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2019-12-09', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-14', 'studyFirstPostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Glucose', 'timeFrame': '180 minutes', 'description': 'Plasma glucose concentration after ketone or placebo ingestion'}], 'secondaryOutcomes': [{'measure': 'Plasma Insulin', 'timeFrame': '180 minutes', 'description': 'Insulin across concentration after ketone or placebo ingestion'}, {'measure': 'Plasma C-peptide', 'timeFrame': '180 minutes', 'description': 'C-peptide across concentration after ketone or placebo ingestion'}, {'measure': 'Plasma Free Fatty Acids', 'timeFrame': '180 minutes', 'description': 'Non-esterified fatty acid concentration after ketone or placebo ingestion'}, {'measure': 'Plasma Tumour Necrosis Factor Alpha', 'timeFrame': '180 minutes', 'description': 'Plasma tumour necrosis factor alpha concentration after ketone or placebo ingestion'}, {'measure': 'Plasma Tumour Interleukin-1beta', 'timeFrame': '180 minutes', 'description': 'Plasma tumour interleukin-1beta concentration after ketone or placebo ingestion'}, {'measure': 'Plasma Tumour Interleukin-6', 'timeFrame': '180 minutes', 'description': 'Plasma tumour interleukin-6 concentration after ketone or placebo ingestion'}, {'measure': 'Cerebral Blood Flow', 'timeFrame': '180 minutes', 'description': 'Intracranial blood flow velocity measured by ultrasound'}, {'measure': 'Blood Pressure', 'timeFrame': '180 minutes', 'description': 'Blood pressure measured manually and by Finipres'}, {'measure': 'Cognitive Function - Digital Symbol Substitution Task', 'timeFrame': '180 minutes', 'description': 'Number of Correct Answers on the Digital Symbol Substitution Task. Measure of cognitive function using Brain Baseline battery on an iPad.'}, {'measure': 'Brain-derived Neurotrophic Factor', 'timeFrame': '180 minutes', 'description': 'Brain-derived neurotrophic factor concentrations after ketone or placebo ingestion'}, {'measure': 'Number Blood Monocytes (x10^3 Cells/uL)', 'timeFrame': '180 minutes', 'description': 'Total blood monocytes count (x10\\^3 cells/uL) after ketone or placebo ingestion'}, {'measure': 'Self Reported Hunger and Fullness', 'timeFrame': '180 minutes', 'description': 'Self reported hunger and fullness by a 0 to 100 mm Visual Analog Scale (higher scores mean greater hunger or fullness)'}, {'measure': 'Gastrointestinal Symptoms', 'timeFrame': '180 minutes', 'description': 'Gastrointestinal symptom questionnaire scores after ketone or placebo ingestion on a 0 to 100 mm Visual Analog Scale (higher scores mean greater symptoms)'}, {'measure': 'Total Energy Consumed', 'timeFrame': '180 minutes after ketone or placebo ingestion', 'description': 'Total energy consumed in kilocalories in buffet style meal after ketone or placebo ingestion'}, {'measure': 'Monocyte Histone Acetylation', 'timeFrame': '180 minutes', 'description': 'Histone acetylation status of monocytes measured after ketone or placebo ingestion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ketosis', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '39804761', 'type': 'DERIVED', 'citation': 'Baranowski BJ, Oliveira BF, Falkenhain K, Little JP, Mohammad A, Beaudette SM, Finch MS, Caldwell HG, Neudorf H, MacPherson REK, Walsh JJ. Effect of exogenous beta-hydroxybutyrate on BDNF signaling, cognition, and amyloid precursor protein processing in humans with T2D and insulin-resistant rodents. Am J Physiol Cell Physiol. 2025 Feb 1;328(2):C541-C556. doi: 10.1152/ajpcell.00867.2024. Epub 2025 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'Exogenous ketone supplements are proposed to have glucose-lowering potential, provide an alternative fuel for the brain and to enhance cognitive function. No studies have tested whether exogenous ketones can lower blood glucose in people with type 2 diabetes. In addition, the impact of exogenous ketones on brain blood flow, cognitive function or brain-derived neurotrophic factor in humans is unknown. The purpose of this study is to determine if acutely ingesting exogenous ketones, in the form of a ketone monoester drink, can lower glucose and improve measures of brain/cognitive function in humans with type 2 diabetes. Participants will consume a ketone monoester drink or placebo with blood samples, brain blood flow, and cognitive function assessed over 180 minutes. The researchers will also test how the ketone monoester drink impacts appetite and measures of inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physician-diagnosed type 2 diabetes of ≥1 year\n* current hemoglobin A1C (HbA1c) of 6.5-8.0%\n* treatment with lifestyle or stable (≥3 months) oral glucose-lowering medications\n* blood pressure of \\<160/99 mm Hg assessed according to guidelines\n* non-smoking\n* no prior history of cardiovascular disease or stroke\n* not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications\n* 20-75 years old\n\nExclusion Criteria:\n\n* being a competitive endurance athlete\n* taking exogenous insulin or sodium glucose transporter 2 (SGLT2) inhibitors\n* following a ketogenic diet, low-calorie diet, periodic fasting regimen, or consume ketogenic supplements\n* being unable to travel to and from the university\n* being unable to follow the controlled diet instructions\n* being pregnant or planning to become pregnant during the study (if female)\n* disorders of fat metabolism, chronic pancreatitis, had gastric bypass surgery and/or gallbladder disease\n* being unable to read or communicate in English'}, 'identificationModule': {'nctId': 'NCT04194450', 'briefTitle': 'Exogenous Ketones in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'The Effect of Acute Exogenous Oral Ketone Supplementation on Blood Glucose Levels in Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'H19-02947'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketone monoester', 'description': 'Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)', 'interventionNames': ['Dietary Supplement: Ketone monoester']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Acute dose of flavour-matched placebo.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Ketone monoester', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.', 'armGroupLabels': ['Ketone monoester']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Acute ingestion of taste-matched placebo prior to assessment of outcomes.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V1V 1V7', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia, Okanagan', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jonathan Little', 'investigatorAffiliation': 'University of British Columbia'}}}}