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NCT07091500Toboroz

Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Therapy and Exercise Training in People With Obesity

Effect of GLP-1 Receptor Agonist Therapy With and Without Exercise Training on Muscle Mass and Physical Function in People With Obesity

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 10.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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, muscle strength and appetite control and reward signaling in the brain in response to 1-year of GLP-1 RA therapy, with or without exercise training, and subsequent treatment cessation on muscle and appetite-related outcomes assessed 1-year after stopping treatment.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
40 (tervezett)
Első benyújtás
2025. júl. 10.
Kezdés
2025. aug. 11.
Elsődleges befejezés
2028. aug. 1.
Fő szponzor
Washington University School of Medicine
Betegségek
Elhízás
NCT-szám
NCT07091500

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 40
  • 2025. aug. 11. és az elsődleges befejezés (2028. aug. 1.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • i) unstable weight (>4% change during the last 2 months before entering the study)
  • 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
  • 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)
  • 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

Más betegség

  • iii) diabetes
  • vii) history of chronic or acute pancreatitis
  • 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
  • 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
  • xx) allergy or hypersensitivity to GLP-1 RA medications

Laborértékek

  • 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])
  • xvi) anemia (Hgb <10 g/dL)

Egyéb

  • ii) ≥150 min per week of structured exercise (e.g., jogging, activities that cause heavy breathing and sweating)
  • xix) Female who is pregnant, breast-feeding or intends to become pregnant
  • 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

Kiket keres a vizsgálat

  • 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.

Életkor a regiszterben: 50 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Washington University School of MedicineSt LouisEgyesült ÁllamokToboroz

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