A phase 3 randomized clinical trial using a once‐weekly glucagon‐like peptide‐1 receptor agonist in adolescents and young adults with hypothalamic obesity
| العنوان: | A phase 3 randomized clinical trial using a once‐weekly glucagon‐like peptide‐1 receptor agonist in adolescents and young adults with hypothalamic obesity |
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| المؤلفون: | M. Jennifer Abuzzahab, Jack A. Yanovski, Clinton Elfers, Christian L. Roth, Ashley H. Shoemaker, Kathryn B. Whitlock, Francisco A. Perez |
| المصدر: | Diabetes, Obesity & Metabolism |
| بيانات النشر: | Blackwell Publishing Ltd, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Adult, medicine.medical_specialty, Adolescent, Nausea, Endocrinology, Diabetes and Metabolism, exenatide, Glucagon-Like Peptides, Blood lipids, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, Placebo, Gastroenterology, Glucagon-Like Peptide-1 Receptor, law.invention, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Endocrinology, Randomized controlled trial, Double-Blind Method, law, Internal medicine, Internal Medicine, randomized trial, Medicine, Humans, Hypoglycemic Agents, Obesity, Child, Glucagon-like peptide 1 receptor, Glycated Hemoglobin, business.industry, Original Articles, Treatment Outcome, Tolerability, Diabetes Mellitus, Type 2, Original Article, medicine.symptom, antiobesity drug, business, Body mass index, Exenatide, medicine.drug |
| الوصف: | Aim To evaluate the efficacy, safety and tolerability of a glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA) in patients with hypothalamic obesity (HO). Materials and Methods A two‐arm, randomized, multicentre, double‐blind, placebo‐controlled trial was conducted in 10‐ to 25‐year‐olds with hypothalamic injury following intracranial tumour and HO. Participants were randomized to once‐weekly subcutaneous injections of a GLP‐1 RA exenatide 2 mg (ExQW) or placebo for 36 weeks. The primary efficacy endpoint was 36‐week % change in body mass index (BMI). Secondary outcomes included change in body composition (by dual energy x‐ray absorptiometry). Results Forty‐two participants were randomized to ExQW (n = 23) or placebo (n = 19). Participants were 5 ± 2 years (mean ± SD) postdiagnosis and development of HO (BMI 37.3 ± 7.1 kg/m2). In intention‐to‐treat analysis, the effect of 36‐week ExQW vs. placebo on % Δ BMI was not significant (estimated treatment difference −1.7 ± 1.8%, 95% CI −4.1 to 0.6%, P = .40); however, total body fat mass was reduced (estimated treatment difference −3.1 ± 1.4 kg, 95% CI −5.7 to −0.4 kg, P = .02). There was a significant reduction in waist circumference (estimated effect of treatment −3.5 [95% CI −5.5 to −1.6] cm, P = .004). All patients treated with placebo increased % of adipose tissue, while 50% treated with ExQW had reductions (P |
| اللغة: | English |
| تدمد: | 1463-1326 1462-8902 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8b42b006eb965282e626072a0f297665Test http://europepmc.org/articles/PMC7821019Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....8b42b006eb965282e626072a0f297665 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14631326 14628902 |
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