Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-01 @ 5:22 PM
Study NCT ID:
NCT06324669
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2024-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Ketone Drink on Blood Glucose Levels in People With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Coded, known only to independent individual'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomised cross over trial counterbalanced for trial order'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of endogenous glucose production', 'timeFrame': '4 hours', 'description': 'Rate of endogenous glucose production over 4 hours in response to a meal measured by blood sample'}], 'secondaryOutcomes': [{'measure': 'Total rate of glucose appearance', 'timeFrame': '4 and 8 hours', 'description': 'Total rate of glucose appearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal'}, {'measure': 'Exogenous glucose rate of appearance', 'timeFrame': '4 and 8 hours', 'description': 'Exogenous rate of glucose appearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal'}, {'measure': 'Total rate of glucose disappearance', 'timeFrame': '4 and 8 hours', 'description': 'Total rate of glucose disappearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal'}, {'measure': 'Rate of gluconeogenesis', 'timeFrame': '4 and 8 hours', 'description': 'Rate of gluconeogenesis measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal'}, {'measure': 'Rate of glycogenolysis', 'timeFrame': '4 and 8 hours', 'description': 'Rate of glycogenolysis measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal'}, {'measure': 'Beta-cell function', 'timeFrame': '4 and 8 hours', 'description': 'Beta-cell function using dynamic modelling of insulin/c-peptide secretion over 4 and 8 hours following a meal'}, {'measure': 'Insulin concentration', 'timeFrame': '4 and 8 hours', 'description': 'Insulin concentration using ELISA assay over 4 and 8 hours following a meal'}, {'measure': 'Glucagon concentration', 'timeFrame': '4 and 8 hours', 'description': 'Glucagon concentration using ELISA assay over 4 and 8 hours following a meal'}, {'measure': 'GLP-1 concentration', 'timeFrame': '4 and 8 hours', 'description': 'GLP-1 using ELISA assay over 4 and 8 hours following a meal'}, {'measure': 'GIP concentration', 'timeFrame': '4 and 8 hours', 'description': 'GIP concentration using ELISA assay over 4 and 8 hours following a meal'}, {'measure': 'Glycerol concentration', 'timeFrame': '4 and 8 hours', 'description': 'Glycerol concentration using colorimetric assay over 4 and 8 hours following a meal'}, {'measure': 'Free fatty acid concentration', 'timeFrame': '4 and 8 hours', 'description': 'Free fatty acids using colorimetric assay over 4 and 8 hours following a meal'}, {'measure': 'Ketone concentration', 'timeFrame': '4 and 8 hours', 'description': 'Ketone concentration using colorimetric assay over 4 and 8 hours following a meal'}, {'measure': 'Energy expenditure', 'timeFrame': '4 and 8 hours', 'description': 'Energy expenditure using indirect calorimetry over 4 and 8 hours following a meal'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. This research will provide new knowledge about the regulation of blood sugar. This may also inform if ketone drinks could be used as a treatment for T2D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '41 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 41-70 years old\n2. Body mass index 27-40 mg/m²\n3. Type 2 diagnosis for more than 1 year\n4. HbA1c \\>6%\n\nExclusion Criteria:\n\n1. Currently following ketogenic diet\n2. Use of insulin\n3. HbA1c \\>10%\n4. Recent weight loss (\\>5kg in 6 months)\n5. Recent eGFR \\<30mL/min\n6. Heart failure\n7. Substance abuse\n8. Cancer\n9. Myocardial infarction within 6 months\n10. Pregnancy or consideration of\n11. Use of antipsychotic drugs'}, 'identificationModule': {'nctId': 'NCT06324669', 'briefTitle': 'The Effect of a Ketone Drink on Blood Glucose Levels in People With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Exeter'}, 'officialTitle': 'Investigating the Blood Glucose Lowering Effect of Exogenous Ketone Ingestion in People With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '4765060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketone supplementation', 'description': '100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ΔG®, University of Oxford; https://www.deltagketones.com)', 'interventionNames': ['Dietary Supplement: Ketone supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo with stevia and bitter agent to flavour match', 'interventionNames': ['Dietary Supplement: Placebo supplement']}], 'interventions': [{'name': 'Ketone supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': '100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ΔG®, University of Oxford; https://www.deltagketones.com) consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day', 'armGroupLabels': ['Ketone supplementation']}, {'name': 'Placebo supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo with stevia and bitter agent to flavour match, consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX1 2LU', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Sport & Health Sciences University of Exeter', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}], 'overallOfficials': [{'name': 'Francis B Stephens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Exeter'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Exeter', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of British Columbia', 'class': 'OTHER'}, {'name': 'Medical Research Council', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}