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.
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
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Washington University School of Medicine | St Louis | Egyesült Államok | Toboroz |
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