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Exogenous Ketones in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT04194450
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

Tracking Information
First Submitted Date  ICMJE December 9, 2019
First Posted Date  ICMJE December 11, 2019
Last Update Posted Date September 28, 2021
Actual Study Start Date  ICMJE January 15, 2020
Estimated Primary Completion Date September 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
Plasma glucose [ Time Frame: 180 minutes ]
Plasma glucose concentration after ketone or placebo ingestion
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2019)
Plasma glucose [ Time Frame: 180 minutes ]
Total plasma glucose as represented by the area below or above baseline fasting glucose
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
  • Plasma insulin [ Time Frame: 180 minutes ]
    Insulin across concentration after ketone or placebo ingestion
  • Plasma C-peptide [ Time Frame: 180 minutes ]
    C-peptide across concentration after ketone or placebo ingestion
  • Plasma free fatty acids [ Time Frame: 180 minutes ]
    Non-esterified fatty acid concentration after ketone or placebo ingestion
  • Plasma tumour necrosis factor alpha [ Time Frame: 180 minutes ]
    Plasma tumour necrosis factor alpha concentration after ketone or placebo ingestion
  • Plasma tumour interleukin-1beta [ Time Frame: 180 minutes ]
    Plasma tumour interleukin-1beta concentration after ketone or placebo ingestion
  • Plasma tumour interleukin-6 [ Time Frame: 180 minutes ]
    Plasma tumour interleukin-6 concentration after ketone or placebo ingestion
  • Cerebral blood flow [ Time Frame: 180 minutes ]
    Intracranial blood flow velocity measured by ultrasound
  • Blood pressure [ Time Frame: 180 minutes ]
    Blood pressure measured manually and by Finipres
  • Cognitive function [ Time Frame: 180 minutes ]
    Measures of cognitive function using Brain Baseline battery on an iPad.
  • Brain-derived neurotrophic factor [ Time Frame: 180 minutes ]
    Brain-derived neurotrophic factor concentrations after ketone or placebo ingestion
  • Blood monocytes [ Time Frame: 180 minutes ]
    Total blood monocytes and monocyte subsets after ketone or placebo ingestion
  • Self reported hunger and fullness [ Time Frame: 180 minutes ]
    Self reported hunger and fullness by a 0 to 100 mm Visual Analog Scale (higher scores mean greater hunger or fullness)
  • Gastrointestinal symptoms [ Time Frame: 180 minutes ]
    Gastroinestinal symptom questionnaire scores after ketone or placebo ingestion on a 0 to 100 mm Visual Analog Scale (higher scores mean greater symptoms)
  • Total energy consumed [ Time Frame: 180 minutes after ketone or placebo ingestion ]
    Total energy consumed in kilocalories in buffet style meal after ketone or placebo ingestion
  • Monocyte histone acetylation [ Time Frame: 180 minutes ]
    Histone acetylation status of monocytes measured after ketone or placebo ingestion
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2019)
  • Plasma insulin [ Time Frame: 180 minutes ]
    Insulin area under the curve after ketone or placebo ingestion
  • Plasma C-peptide [ Time Frame: 180 minutes ]
    C-peptide area under the curve after ketone or placebo ingestion
  • Plasma free fatty acids [ Time Frame: 180 minutes ]
    Non-esterified fatty acid concentration after ketone or placebo ingestion
  • Plasma tumour necrosis factor alpha [ Time Frame: 180 minutes ]
    Plasma tumour necrosis factor alpha concentration after ketone or placebo ingestion
  • Plasma tumour interleukin-1beta [ Time Frame: 180 minutes ]
    Plasma tumour interleukin-1beta concentration after ketone or placebo ingestion
  • Plasma tumour interleukin-6 [ Time Frame: 180 minutes ]
    Plasma tumour interleukin-6 concentration after ketone or placebo ingestion
  • Cerebral blood flow [ Time Frame: 180 minutes ]
    Intracranial blood flow velocity measured by ultrasound
  • Blood pressure [ Time Frame: 180 minutes ]
    Blood pressure measured manually and by Finipres
  • Cognitive function [ Time Frame: 180 minutes ]
    Measures of cognitive function using Brain Baseline battery on an iPad.
  • Brain-derived neurotrophic factor [ Time Frame: 180 minutes ]
    Brain-derived neurotrophic factor concentrations after ketone or placebo ingestion
  • Blood monocytes [ Time Frame: 180 minutes ]
    Total blood monocytes and monocyte subsets after ketone or placebo ingestion
  • Self reported hunger and fullness [ Time Frame: 180 minutes ]
    Self reported hunger and fullness by a Visual Analog Scale
  • Gastrointestinal symptoms [ Time Frame: 180 minutes ]
    Gastroinestinal symptom questionnaire scores after ketone or placebo ingestion
  • Total energy consumed [ Time Frame: 180 minutes after ketone or placebo ingestion ]
    Total energy consumed in kilocalories in buffet style meal after ketone or placebo ingestion
  • Monocyte histone acetylation [ Time Frame: 180 minutes ]
    Histone acetylation status of monocytes measured after ketone or placebo ingestion
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exogenous Ketones in Type 2 Diabetes
Official Title  ICMJE The Effect of Acute Exogenous Oral Ketone Supplementation on Blood Glucose Levels in Type 2 Diabetes
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Placebo masked with flavouring and participants consume in opaque containers.
Primary Purpose: Basic Science
Condition  ICMJE
  • Ketosis
  • Type 2 Diabetes
Intervention  ICMJE
  • Dietary Supplement: Ketone monoester
    Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.
  • Dietary Supplement: Placebo
    Acute ingestion of taste-matched placebo prior to assessment of outcomes.
Study Arms  ICMJE
  • Experimental: Ketone monoester
    Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 ml/kg body weight)
    Intervention: Dietary Supplement: Ketone monoester
  • Placebo Comparator: Placebo
    Acute dose of flavour-matched placebo.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 9, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2022
Estimated Primary Completion Date September 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • physician-diagnosed type 2 diabetes of ≥1 year
  • current hemoglobin A1C (HbA1c) of 6.5-8.0%
  • treatment with lifestyle or stable (≥3 months) oral glucose-lowering medications
  • blood pressure of <160/99 mm Hg assessed according to guidelines
  • non-smoking
  • no prior history of cardiovascular disease or stroke
  • not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications
  • 20-75 years old

Exclusion Criteria:

  • being a competitive endurance athlete
  • taking exogenous insulin or sodium glucose transporter 2 (SGLT2) inhibitors
  • following a ketogenic diet, low-calorie diet, periodic fasting regimen, or consume ketogenic supplements
  • being unable to travel to and from the university
  • being unable to follow the controlled diet instructions
  • being pregnant or planning to become pregnant during the study (if female)
  • disorders of fat metabolism, chronic pancreatitis, had gastric bypass surgery and/or gallbladder disease
  • being unable to read or communicate in English
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jonathan Little, PhD 2508079876 jonathan.little@ubc.ca
Contact: Barbara Oliveira, PhD, RD barbara.oliveira@ubc.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04194450
Other Study ID Numbers  ICMJE H19-02947
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jonathan Little, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of British Columbia
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP