Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging

  • STATUS
    Recruiting
  • participants needed
    40
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Updated on 19 February 2024

Summary

Randomized, single blinded crossover trial testing optimal interventions to adequately suppress myocardial glucose suppression. We will enroll up to 50 subjects in order to reach our target of 40 fully evaluable; 20 healthy volunteers and 20 patients with Type 2 diabetes mellitus. We will test whether dietary modification (ketogenic diet) or exogenous ketone administration will provide enhanced myocardial glucose suppression. This study design is multi-arm. ARM 1: Subjects will undergo FDG PET/CT after 1 day of dietary modification (ketogenic diet for at least 3 meals) and 12 hours of fasting prior to FDG injection. Then subjects will undergo FDG PET/CT after 3 day of dietary modification (ketogenic diet for at least 9 meals) and 12 hours of fasting prior to FDG injection. ARM 2: Subjects will undergo FDG PET/CT after 1 dose of ketone drink administration after 12 hours of fasting prior to FDG injection. The dosing of ketone drink administration (approximately 65 mL) will be weight based (714 mg/kg), which is crucial to replicating ketone levels between participants.22 The KE drink will be administered approximately 45 minutes prior to FDG injection as concentrations of ~3 mmol/L are reached within 60 minutes16 18 . By way of comparison, website marketing of the commercial drink recommends ingestion 30 minutes prior to athletic performance. We will also perform echocardiography immediately before and 30 minutes after the drink.

Details
Condition Medical Research
Age 99years or below
Clinical Study IdentifierTBD
Last Modified on19 February 2024

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