Relationship Between Brain and Heart Glucose Metabolism in Alcohol Use Disorder

NCT05015881 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: 848992
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder (AUD); Alcohol Drinking

Keywords

Ester Keytone; MRI; PET scan; Echocardiogram

Outcome Measures

Primary Outcomes (1)

• FDG uptake (CMRg) in the brain and heart

  The primary outcome measure to be analyzed is a comparisons of AUD subjects and healthy control subjects in the amount of FDG uptake (CMRg metabolic rate of glucose) in brain and heart.

  4 hours

Secondary Outcomes (3)

• Amount of FDG uptake (CMRg)

  4 hours

• Amount of blood glucose (mmol/L or mg/dl)

  4 hours

• Amount of BHB (beta-hydroxybutyrate) (mmol/L)

  4 hours

Study Arms (2)

Ketone ester + echocardiogram + PET FDG scanning visit.

ACTIVE COMPARATOR

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.

Dietary Supplement: Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate"; Drug: FDG

Echocardiogram + PET FDG scanning visit.

OTHER

Subjects will complete a echocardiogram + PET scanning visit. 2-Deoxy-2-\[18F\] fluoro-D-glucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scan.

Drug: FDG

Interventions

Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate" DIETARY_SUPPLEMENT

Drink a single dose of ketone ester 1.9 kcal/kg

Also known as: DeltaG

Ketone ester + echocardiogram + PET FDG scanning visit.

FDG DRUG

Echocardiogram, and 2-Deoxy-2-\[18F\] fluoro-D-glucose (FDG) PET scan.

Also known as: 2-Deoxy-2-[18F] fluoro-D-glucose (FDG)

Echocardiogram + PET FDG scanning visit.; Ketone ester + echocardiogram + PET FDG scanning visit.

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 years to 65 years old.
• Willingness to provide signed, informed consent and commit to completing the procedures in the study
• Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
• Participants must agree to not consume alcohol beverages for 24 hours prior to each laboratory session.
• Meets DSM-5 criteria for current AUD
• Participants report average weekly ethanol consumption of at least 15 standard drinks weekly over the past month prior to consent (self-report)
• Minimum 1 year history of heavy drinking (self-report).
• Must have had last drink within 1 week of PET visits.
• Alcohol specified as the preferred drug (self-report).
• AUDIT score \< 6
• Drinks alcohol 15 standard drinks or less per month and 3 or less standard drinks per occasion.
• Females who are pregnant or breast-feeding will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test prior to FDG injection.
• Unwilling or unable to refrain from use, within 24 hours of FDG PET/CT scan procedures, psychoactive medications or medication that may affect study results (e.g., analgesics containing narcotics, antibiotics, anti-inflammatory drugs).
• Current DSM-5 diagnosis of a major psychiatric disorder (other than nicotine use disorders, or marijuana use disorders that are mild/moderate in both groups; and alcohol in the AUD group) that required hospitalization, or that required daily medications for over 4 weeks in the past year (i.e., antidepressants; anticholinergics; antipsychotics; anxiolytics; lithium; psychotropic drugs not otherwise specified (nos) including herbal products (no drugs with psychomotor effects or with anxiolytics, stimulant, antipsychotic, or sedative properties); sedatives/hypnotics).
• Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.

You may not qualify if:

• Current DSM-5 diagnosis of Alcohol use disorder

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Center for Studies of Addiction

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking

Interventions

rVSV-deltaG-spike COVID-19 vaccine; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Corinde E Wiers, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, 2-way crossover trial in 10 individuals with AUD and 10 Healthy controls

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 20, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)