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治験 NCT07091500（対象：肥満、骨格筋）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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セントルイスのワシントン大学Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Therapy and Exercise Training in People With Obesity
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 NCT07091500 は 介入研究 臨床試験 で、肥満、骨格筋 に関するものです。現在は 募集中 で、2025年8月11日 から開始しています。40 名の参加者 の募集が計画されています。この治験は セントルイスのワシントン大学 によって主催され、2029年8月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月23日 です。
概要
The use of glucagon-like peptide receptor agonists (GLP-1 RAs) may have clinically important effects on skeletal muscle mass (SMM), and physical function. The effects of exercise training in conjunction with GLP-1 RA therapy on these outcomes has not been studied. Additionally, most people treated with GLP-1-based weight loss medications stop taking these medications within 1 year of initiating treatment. This is an important clinical concern because weight regain can occur after weight loss pharmacotherapy is stopped and the impact of stopping GLP-1 RA therapy on physical and metabolic function has not been studied.
In this study, the investigators will conduct a 2-year randomized clinical trial to evaluate body composition, muscle physical and metabolic function, and muscle strength in response to GLP-1 RA therapy, with or without exercise training, and subsequent treatment cessation on muscle-related outcomes.
公式タイトル
Effect of GLP-1 Receptor Agonist Therapy With and Without Exercise Training on Muscle Mass and Physical Function in People With Obesity
疾患／病気
肥満骨格筋その他の研究識別子
- 202505162
主目的
基礎研究
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬GLP-1 RA Participants in this group will receive semaglutide therapy along with diet behavior counseling for 52 weeks | Semaglutide semaglutide 2.4 mg subcutaneous per week or max tolerated dose and diet behavior counseling |
実験的GLP-1 RA + Exercise Participants in this group will receive semaglutide therapy along with diet behavior counseling and exercise training for 52 weeks. | 運動トレーニング Participants will perform supervised exercise training sessions 3 days per week and unsupervised at-home sessions 2-3 days per week. Semaglutide semaglutide 2.4 mg subcutaneous per week or max tolerated dose and diet behavior counseling |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Physical function | Score on the Modified Physical Performance Test | Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention |
Body composition | DEXA scan | Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Muscle mass | Whole-body muscle mass will assessed by using the D3-creatine dilution method | Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention |
Muscle volume | Magnetic resonance scans | Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention |
Insulin sensitivity | Whole-body insulin sensitivity during a hyperinsulinemic-euglycemic clamp | Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention |
Muscular Strength for the Chest Press exercise | Upper body muscle strength will be assessed as a ten repetition maximal strength for the chest press exercise on a Hoist multi-station weight machine | Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention |
Muscular Strength for the Seated Row exercise | Upper body muscle strength will be assessed as a ten repetition maximal strength for the seated row exercise | Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention |
Muscular Strength for the Leg Press exercise | Lower body muscle strength will be assessed as a ten repetition maximal strength for the leg press exercise | Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention |
Muscular Strength for the Leg Flexion exercise | Lower body muscle strength will be assessed as a ten repetition maximal strength for the leg flexion exercise | Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
50 Years
対象性別
全て
- i) obesity (Body Mass Index ≥ 30 kg/m2)
- ii) decreased physical function (Modified Physical Performance Test score 17 to 31)
- iii) approval of their primary physician to participate in this study.
- i) unstable weight (>4% change during the last 2 months before entering the study)
- ii) ≥150 min per week of structured exercise (e.g., jogging, activities that cause heavy breathing and sweating)
- iii) diabetes
- iv) significant cardiopulmonary disease (heart failure, angina, uncontrolled hypertension, chronic obstructive pulmonary disease) or other organ dysfunction (e.g., renal insufficiency [eGFR <30 mL/min/1.73 m2])
- v) therapy with a GLP-1 or other weight loss medications
- vi) clinically significant gastric emptying abnormality or chronically take drugs that directly affect gastrointestinal motility
- vii) history of chronic or acute pancreatitis
- viii) thyroid-stimulating hormone (TSH) >1.5X the upper limit of normal (patients receiving treatment for hypothyroidism may be included provided their thyroid hormone replacement dose has been stable for at least 3 months)
- ix) history of significantly active or unstable Major Depressive Disorder or other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 months that would interfere with study participation
- x) acute or chronic hepatitis, or other liver disease other than Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD)
- xi) family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- xii) history of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
- xiii) tobacco use, excessive alcohol intake (≥3 drinks/day for men and ≥2 drinks/day for women) or active substance abuse with illegal drugs by self-report, or regular marijuana use within 3 months of enrollment and unwilling to abstain from marijuana during the trial
- xiv) Use of medications that are known to affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued for this study
- xv) have had bariatric surgery or plan to have endoscopic or bariatric surgery therapy for obesity
- xvi) anemia (Hgb <10 g/dL)
- xvii) Conditions that render subject unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders)
- xii) history of seizure disorder
- xix) Female who is pregnant, breast-feeding or intends to become pregnant
- xx) allergy or hypersensitivity to GLP-1 RA medications
- xxi) unable to grant voluntary informed consent
- xxii) unable or unwilling to follow the study protocol or who, for any reason, the research team considers the participant is not an appropriate candidate for the study
セントルイスのワシントン大学476 件のアクティブな治験を探索試験中央連絡先
連絡先: Coordinator, 314-273-1879, [email protected]
1 1カ国の場所
Missouri
Washington University School of Medicine, St Louis, Missouri, 63110, United States
Coordinator, 連絡先, 314-273-1879
募集中