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治験 NCT04987879 (AMPED)（対象：非アルコール性脂肪性肝疾患 (NAFLD)）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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NASH AMPK Exercise Dosing (AMPED) Trial

募集中
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT04987879 (AMPED) は 介入研究 臨床試験 で、非アルコール性脂肪性肝疾患 (NAFLD) に関するものです。現在は 募集中 で、2022年8月30日 から開始しています。45 名の参加者 の募集が計画されています。この治験は Milton S. Hershey Medical Center によって主催され、2026年7月15日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年10月14日 です。
概要
There is no known cure or regulatory agency approved drug therapy for nonalcoholic fatty liver disease (NAFLD), the leading cause of liver disease worldwide, and its progressive type, NASH. This places increased importance on using exercise to treat NAFLD.

While physical activity is recommended for all with NAFLD, how to best prescribe exercise as a specific treatment remains unknown, including what dose of exercise is most effective.

詳細説明
The mechanism explaining how exercise training benefits patients with NAFLD and NASH is unclear. The AMPK pathway may be responsible for the benefits seen with exercise training because: 1) AMPK has a liver-specific role in hepatic de novo lipogenesis and fatty acid oxidation, 2) AMPK activity is abnormally low in NAFLD and 3) NAFLD animal models demonstrate exercise changes the liver-specific AMPK pathway, leading to less liver fat accumulation by reducing lipogenesis and increasing fatty acid oxidation (This has not been studied in patients). Importantly, exercise-induced AMPK activation appears to be dose dependent.
公式タイトル

NASH AMPK Exercise Dosing (AMPED) Trial

疾患／病気
非アルコール性脂肪性肝疾患 (NAFLD)
その他の研究識別子
NCT番号
NCT04987879
開始日
2022-08-30
最終更新日
2025-10-14
終了予定日
2026-07-15
目標参加者数
45
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
実験的Exercise Arm 1
Aerobic exercise will be completed by walking, jogging or running or by using cardio equipment (e.g., recumbent bike). Each session will begin with a warm-up with walking and dynamic exercises. A 5-min walking cool down will end the session. The training dose for this arm is 750 MET-min/wk for 3-5 days per week, 22-45 minutes per session at a moderate to vigorous intensity. The exercise can be completed in person or virtually.
運動
Aerobic exercise can be completed by walking, jogging or running or by using cardio equipment (e.g., recumbent bike). Each session will begin with a warm-up with walking (30-40% target HR for 5-min) and dynamic exercises (knee-to-chest, 10-yd lateral shuffle, bent over twist, calf sweeps, leg swings). A 5-min walking cool down will end the session (30-40% target HR).
実験的Exercise Arm 2
Aerobic exercise will be completed by walking, jogging or running or by using cardio equipment (e.g., recumbent bike). Each session will begin with a warm-up with walking and dynamic exercises. A 5-min walking cool down will end the session. The training dose for this arm is 1,000 MET-min/wk for 3-5 days per week, 30-60 minutes per session at a moderate to vigorous intensity. The exercise can be completed in person or virtually.
運動
Aerobic exercise can be completed by walking, jogging or running or by using cardio equipment (e.g., recumbent bike). Each session will begin with a warm-up with walking (30-40% target HR for 5-min) and dynamic exercises (knee-to-chest, 10-yd lateral shuffle, bent over twist, calf sweeps, leg swings). A 5-min walking cool down will end the session (30-40% target HR).
非介入Standard of Care
This group will receive best NASH clinical practices counseling at baseline and end-of-trial in accordance with NAFLD clinical practice guidelines and be reinforced by handouts from the American Liver Foundation.
該当なし
主要評価項目
評価指標指標の説明時間枠
Change in liver fat
Degree of liver fat change as measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF) across different doses of exercise in patients with NASH.
16 weeks
副次評価項目
評価指標指標の説明時間枠
Hip/waist circumference
change in Hip/waist circumference
16 weeks
Body mass index
change in body mass index
16 weeks
change in body composition
change in body composition as measured by Dual-energy X-ray absorptiometry (DXA scan) across different doses of exercise in patients with NASH.
16 weeks
Insulin
change in insulin
16 weeks
Hemoglobin A1c
change in Hemoglobin A1c
16 weeks
change in cholesterol and triglycerides levels (dyslipidemia)
change in cholesterol and triglycerides levels (dyslipidemia) as measured by clinical labs.
16 weeks
Interleukin-6
change in Interleukin-6
16 weeks
c-reactive protein
change in c-reactive protein
16 weeks
Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score
change in NAFLD Fibrosis Score which estimates amount of scarring in the liver based on several laboratory tests. NAFLD Score Correlated Fibrosis Severity \< -1.455 F0-F2 -1.455 - 0.675 Indeterminant score \> 0.675 F3-F4 Fibrosis Severity Scale F0 = no fibrosis F1 = mild fibrosis F2 = moderate fibrosis F3 = severe fibrosis F4 = cirrhosis
16 weeks
Enhance liver fibrosis (ELF) test
change in Enhance liver fibrosis (ELF) test
16 weeks
TIMP-1
change in TIMP-1
16 weeks
ProC3
change in ProC3
16 weeks
Adiponectin
change in Adiponectin
16 weeks
Fibroblast Growth Factor (FGF) 21
change in Fibroblast Growth Factor (FGF) 21
16 weeks
Change in stiffness of the liver
Change in stiffness of the liver as measured by the technique of transient elastography, a non-invasive test to stage the severity of liver disease.
16 weeks
Liver glycogen
change in liver glycogen
16 weeks
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て

  • Age 18-69 years

  • Sedentary [<90 min/wk of exercise identified by the Get Active Questionnaire (GAQ)

  • BMI >25kg/m2

  • Liver biopsy within six months prior to enrollment showing:

    • NASH defined by NASH Clinical Research Network (CRN) histology scoring system (NAS) >4 and MRI-PDFF >5% and;
    • Liver fibrosis stage 1-3

  • Active cardiac symptoms
  • Body mass index (BMI) >45kg/m2
  • Cancer that is active
  • Inability to walk >2 blocks
  • Institutionalized/prisoner
  • Other liver disease
  • Pregnancy
  • Secondary hepatic steatosis
  • Severe comorbidities
  • AUDIT-C questionnaire identified significant alcohol use
  • Substance abuse/active smoking
  • Uncontrolled diabetes (changes in drug dosing over previous three months or A1c >9%)
  • GAQ response indicates exercise may be unsafe.
Milton S. Hershey Medical Center logoMilton S. Hershey Medical Center
責任者
Christopher Sciamanna, MD, MPH, 研究責任者, Professor, Department of Medicine and Public Health Sciences, Penn State Health Milton S Hershey Medical Center
試験中央連絡先
連絡先: Breianna L Hummer, MS, 7175310003, [email protected]
1 1カ国の場所

Pennsylvania

Penn State Hershey Medical Center, Hershey, Pennsylvania, 17033, United States
Breianna L Hummer, MS, 連絡先, 7175310003, [email protected]
Christopher Sciamanna, MD, 研究責任者
募集中