Relationship Between Brain and Heart Glucose Metabolism in Alcohol Use Disorder

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT05015881
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

  • Alcohol Drinking
  • Alcohol Use Disorder (AUD)

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate" — DIETARY_SUPPLEMENT
    Drink a single dose of ketone ester 1.9 kcal/kg
  • FDG — DRUG
    Echocardiogram, and 2-Deoxy-2-\[18F\] fluoro-D-glucose (FDG) PET scan.

Study Details

The goal of this study is to learn more about how a nutritional supplement "ketone ester" (deltaG ®) has an effect on brain and heart function and on alcohol consumption in individuals with and without alcohol use disorder. The study will use Fluorodeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scans after a single dose of ketone ester or Placebo in 10 people with alcohol use disorder and 10 healthy control volunteers.

Key Dates

Start date
Nov 1, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Ketone ester + echocardiogram + PET FDG scanning visit.
    Subjects will drink single dose of ketone ester 1.9 kcal/kg + echocardiogram + PET scanning visit. Dietary Supplement: Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate" (R)-3-hydroxybutyrate (commercially available as DeltaG, (TdeltaS, Orlando, FL). 2-Deoxy-2-\[18F\] fluoro-D-glucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scan.
  • Other: Echocardiogram + PET FDG scanning visit.
    Subjects will complete a echocardiogram + PET scanning visit. 2-Deoxy-2-\[18F\] fluoro-D-glucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scan.

Primary Outcome Measure

FDG uptake (CMRg) in the brain and heart [ Time Frame: 4 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania Center for Studies of AddictionPhiladelphiaPennsylvania19104-

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University of Pennsylvania Center for Studies of Addiction· Philadelphia, PA

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