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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 : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Ketosis Type 2 Diabetes Dietary Supplement: Ketone monoester Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: The Effect of Acute Exogenous Oral Ketone Supplementation on Blood Glucose Levels in Type 2 Diabetes
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : September 20, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketone monoester
Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 ml/kg body weight)
Dietary Supplement: Ketone monoester
Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.

Placebo Comparator: Placebo
Acute dose of flavour-matched placebo.
Dietary Supplement: Placebo
Acute ingestion of taste-matched placebo prior to assessment of outcomes.




Primary Outcome Measures :
  1. Plasma glucose [ Time Frame: 180 minutes ]
    Plasma glucose concentration after ketone or placebo ingestion


Secondary Outcome Measures :
  1. Plasma insulin [ Time Frame: 180 minutes ]
    Insulin across concentration after ketone or placebo ingestion

  2. Plasma C-peptide [ Time Frame: 180 minutes ]
    C-peptide across concentration after ketone or placebo ingestion

  3. Plasma free fatty acids [ Time Frame: 180 minutes ]
    Non-esterified fatty acid concentration after ketone or placebo ingestion

  4. Plasma tumour necrosis factor alpha [ Time Frame: 180 minutes ]
    Plasma tumour necrosis factor alpha concentration after ketone or placebo ingestion

  5. Plasma tumour interleukin-1beta [ Time Frame: 180 minutes ]
    Plasma tumour interleukin-1beta concentration after ketone or placebo ingestion

  6. Plasma tumour interleukin-6 [ Time Frame: 180 minutes ]
    Plasma tumour interleukin-6 concentration after ketone or placebo ingestion

  7. Cerebral blood flow [ Time Frame: 180 minutes ]
    Intracranial blood flow velocity measured by ultrasound

  8. Blood pressure [ Time Frame: 180 minutes ]
    Blood pressure measured manually and by Finipres

  9. Cognitive function [ Time Frame: 180 minutes ]
    Measures of cognitive function using Brain Baseline battery on an iPad.

  10. Brain-derived neurotrophic factor [ Time Frame: 180 minutes ]
    Brain-derived neurotrophic factor concentrations after ketone or placebo ingestion

  11. Blood monocytes [ Time Frame: 180 minutes ]
    Total blood monocytes and monocyte subsets after ketone or placebo ingestion

  12. 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)

  13. 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)

  14. 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

  15. Monocyte histone acetylation [ Time Frame: 180 minutes ]
    Histone acetylation status of monocytes measured after ketone or placebo ingestion



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194450


Contacts
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Contact: Jonathan Little, PhD 2508079876 jonathan.little@ubc.ca
Contact: Barbara Oliveira, PhD, RD barbara.oliveira@ubc.ca

Locations
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Canada, British Columbia
University of British Columbia, Okanagan Recruiting
Kelowna, British Columbia, Canada, V1V 1V7
Contact: Jonathan Little, PhD    2508079876    jonathan.little@ubc.ca   
Sponsors and Collaborators
University of British Columbia
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Responsible Party: Jonathan Little, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04194450    
Other Study ID Numbers: H19-02947
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases