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Exercise Training Decreases Alcohol Consumption and Tissue Injury by an FGF21-dependent Mechanism

11. september 2026 opdateret af: Srinivasan Dasarathy, The Cleveland Clinic
This randomized study will examine whether a 12-week supervised home-based endurance exercise program can reduce alcohol use and alcohol craving in adults with alcohol use disorder (AUD) and alcohol-related liver disease (ALD). Thirty participants will be assigned in a 1:1 ratio to endurance exercise plus standard of care or standard of care alone. Participants in the exercise group will cycle at home three days per week for approximately 60 minutes per session with remote supervision. The study will also evaluate effects of exercise on FGF21, liver injury markers, exercise capacity, physical function, body composition, fatigue, skeletal muscle and mitochondrial function, and exploratory molecular and microbiome measures. The investigators hypothesize that endurance exercise will reduce alcohol use and craving while improving liver and skeletal muscle outcomes, potentially through an FGF21-related mechanism.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Alcohol use disorder is a major driver of continued liver injury in alcohol-related liver disease. Patients with ALD also commonly develop sarcopenia, impaired skeletal muscle function, fatigue, mitochondrial dysfunction, reduced exercise capacity, and physical frailty. Exercise may improve muscle and metabolic function and may also reduce alcohol craving and consumption. FGF21 has been proposed as a mechanistic link among exercise, skeletal muscle, liver injury, metabolism, and alcohol-related behavior.

This is a randomized, controlled, unblinded study of 30 adults with AUD/ALD. Participants will be randomized 1:1 to endurance exercise plus standard of care (EE+SOC) or standard of care alone (SOC). Participants assigned to EE+SOC will complete a 12-week home-based supervised cycling program three days per week, with a target of approximately 60 minutes per session and intensity adjusted for safety, tolerance, and beta-blocker use. Exercise sessions will be remotely monitored, and fitness testing will occur at Cleveland Clinic. Participants in the SOC arm will continue usual clinical care and their usual physical activity without the structured exercise intervention.

The study will assess alcohol consumption and craving; circulating and skeletal muscle FGF21; liver injury measures; exercise capacity and physical performance; body composition; fatigue; skeletal muscle metabolism and mitochondrial function; and exploratory transcriptomic, proteomic, metabolomic, microbiome, amino acid, protein synthesis, TCA intermediate, and cell-signaling responses.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Annette Bellar, PhD
  • Telefonnummer: 216-445-6268
  • E-mail: bellara@ccf.org

Undersøgelse Kontakt Backup

  • Navn: Research Coordinator
  • Telefonnummer: 216-445-6268

Studiesteder

  • Forenede Stater
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Rekruttering
        • Cleveland Clinic
        • Ledende efterforsker:
          • Srinivasan Dasarathy, MD
        • Kontakt:
          • Annette Program Manager, PhD
          • Telefonnummer: 216-445-6268
          • E-mail: bellara@ccf.org

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • • Adults age 18 years or older, of either sex.

    • Clinical diagnosis of alcohol use disorder (AUD) / alcohol-related liver disease (ALD).
    • Meets NIAAA hazardous-drinking criteria: at least 7 drinks/week for women or 14 drinks/week for men for more than 6 months, with ongoing alcohol use within 2 months of evaluation.
    • MELD score less than 21.
    • Able to safely participate in exercise testing and endurance exercise.
    • Able to provide informed consent.
    • No concurrent renal, cardiac, pulmonary, cerebrovascular, or malignant illness that affects skeletal muscle mass; no diabetes mellitus; and no use of medications that affect skeletal muscle mass/protein turnover as described in the protocol, including anabolic steroids, high-dose corticosteroids, or anticoagulants.

Exclusion Criteria:

  • • Pedal edema above the ankle or grade 2 pedal edema.

    • Liver transplant.
    • Active malignancy.
    • Gastrointestinal bleed within the previous 4 weeks.
    • Hepatic encephalopathy within the previous 6 months.
    • Grade 2 or greater active esophageal varices.
    • Active infection.
    • Large ascites by clinical and/or imaging criteria.
    • Advanced cardiac disease (NYHA class 3 or 4) or advanced pulmonary disease (GOLD class 3 or 4).
    • Use of medications affecting muscle protein turnover, including corticosteroids, or medications used to prevent clotting.
    • Prior orthopedic surgery or chronic joint pain that, in the opinion of the PI, may inhibit participation.
    • INR greater than 1.7 or platelet count less than 60,000/mL.
    • Unable to provide informed consent; judged likely to be unable to perform exercise or unlikely to complete the study in the opinion of the investigators.
    • End-stage kidney disease defined as eGFR less than 15 mL/min/1.73 m² or dialysis.
    • Considered unsafe for exercise in the opinion of the PI.
    • Failure to pass the exercise stress test.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Endurance Exercise
Participants will receive standard of care and complete a 12-week supervised home-based endurance exercise program using a recumbent exercise bike.
Adfærdsmæssigt: Endurance Exercise
Stationary/recumbent cycling three days per week for approximately 60 minutes per session for 12 weeks. Exercise intensity is targeted at approximately 60-70% heart rate reserve and adjusted for safety, tolerance, and beta-blocker use. Sessions are remotely monitored by the study team. Participants who cannot exercise continuously may use rest breaks and complete the prescribed exercise within the limits described in the protocol.
Ingen indgriben: Standard of Care
Participants will continue usual clinical care and their current pattern of physical activity and will not participate in the structured endurance exercise intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Alcohol Consumption Measured by Timeline Follow Back (TLFB)
Tidsramme: Baseline to 12 weeks
Alcohol consumption will be assessed using the Timeline Follow Back (TLFB). The primary comparison is change over 12 weeks between the EE+SOC and SOC groups.
Baseline to 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Alcohol Cravings Measured by the Penn Alcohol Cravings Scale (PACS)
Tidsramme: Baseline to 12 weeks
Alcohol craving will be assessed using the Penn Alcohol Craving Scale (PACS). The primary comparison is change over 12 weeks between the EE+SOC and SOC groups.
Baseline to 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Cleveland Clinic

Efterforskere

  • Ledende efterforsker: Srinivasan Dasarathy, MD, The Cleveland Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. oktober 2026

Primær færdiggørelse (Anslået)

31. december 2031

Studieafslutning (Anslået)

31. december 2031

Datoer for studieregistrering

Først indsendt

11. september 2026

Først indsendt, der opfyldte QC-kriterier

11. september 2026

Først opslået (Faktiske)

17. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26-528

Plan for individuelle deltagerdata (IPD)

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