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

11. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studer Kontakt Backup

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

Studiesteder

  • Forente stater
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Rekruttering
        • Cleveland Clinic
        • Hovedetterforsker:
          • Srinivasan Dasarathy, MD
        • Ta kontakt med:
          • Annette Program Manager, PhD
          • Telefonnummer: 216-445-6268
          • E-post: bellara@ccf.org

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Endurance Exercise
Participants will receive standard of care and complete a 12-week supervised home-based endurance exercise program using a recumbent exercise bike.
Atferdsmessig: 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 inngripen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Cleveland Clinic

Etterforskere

  • Hovedetterforsker: Srinivasan Dasarathy, MD, The Cleveland Clinic

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

25. oktober 2026

Primær fullføring (Antatt)

31. desember 2031

Studiet fullført (Antatt)

31. desember 2031

Datoer for studieregistrering

Først innsendt

11. september 2026

Først innsendt som oppfylte QC-kriteriene

11. september 2026

Først lagt ut (Faktiske)

17. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 26-528

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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