A Pilot Randomized Clinical Trial of Intranasal Oxytocin to Promote Weight Loss in Individuals With Hypothalamic Obesity.
A Pilot Randomized Clinical Trial of Intranasal Oxytocin to Promote Weight Loss in Individuals With Hypothalamic Obesity.
复制标题
DOI：
10.1210/jendso/bvad037
复制
发表时间：
2023-03-06
影响因子：
4.1
通讯作者：
Lawson, Elizabeth A.
中科院分区：
文献类型：
--
作者：
McCormack, Shana E.;Wang, Zi;Wade, Kristin L.;Dedio, Anna;Cilenti, Nicolette;Crowley, Julia;Plessow, Franziska;Bamba, Vaneeta;Roizen, Jeffrey D.;Jiang, Yaoguang;Stylli, Jack;Ramakrishnan, Arjun;Platt, Michael L.;Shekdar, Karuna;Fisher, Michael J.;Vetter, Victoria L.;Hocking, Matthew;Xiao, Rui;Lawson, Elizabeth A.
关键词：
Hypothalamic obesity is a rare, treatment-resistant form of obesity. In preliminary studies, the hypothalamic hormone oxytocin (OXT) has shown promise as a potential weight loss therapy. To determine whether 8 weeks of intranasal OXT (vs 8 weeks of placebo) promotes weight loss in children, adolescents, and young adults with hypothalamic obesity. This randomized, double-blind, placebo-controlled, crossover pilot trial (NCT02849743), conducted at an outpatient academic medical center, included patients aged 10 to 35 years with hypothalamic obesity from hypothalamic/pituitary tumors. Participants received intranasal OXT (Syntocinon, 40 USP units/mL, 4 IU/spray) vs excipient-matched placebo, 16 to 24 IU 3 times daily at mealtimes. Weight loss attributable to OXT vs placebo and safety (adverse events) were assessed. Of 13 individuals randomized (54% female, 31% pre-pubertal, median age 15.3 years, IQR 13.3-20.6), 10 completed the entire study. We observed a nonsignificant within-subject weight change of −0.6 kg (95% CI: −2.7, 1.5) attributable to OXT vs placebo. A subset (2/18 screened, 5/13 randomized) had prolonged QTc interval on electrocardiography prior to screening and/or in both treatment conditions. Overall, OXT was well-tolerated, and adverse events (epistaxis and nasal irritation, headache, nausea/vomiting, and changes in heart rate, blood pressure, and QTc interval) were similar between OXT and placebo. In exploratory analyses, benefits of OXT for anxiety and impulsivity were observed. In this pilot study in hypothalamic obesity, we did not detect a significant impact of intranasal OXT on body weight. OXT was well-tolerated, so future larger studies could examine different dosing, combination therapies, and potential psychosocial benefits.
登录
查看更多内容
影响因子：
3.9
作者：
Anekonda VT;Thompson BW;Ho JM;Roberts ZS;Edwards MM;Nguyen HK;Dodson AD;Wolden-Hanson T;Chukri DW;Herbertson AJ;Graham JL;Havel PJ;Wietecha TA;O'Brien KD;Blevins JE
通讯作者：
Blevins JE
影响因子：
6.9
作者：
Bishop-Gilyard, Chanelle T.;Berkowitz, Robert I.;Moore, Renee H.
通讯作者：
Moore, Renee H.
影响因子：
2.2
作者：
EPSTEIN, NB;BALDWIN, LM;BISHOP, DS
通讯作者：
BISHOP, DS
影响因子：
8
作者：
Dykens, Elisabeth M.;Miller, Jennifer;Korner, Paul
通讯作者：
Korner, Paul
影响因子：
2.9
作者：
Blevins JE;Baskin DG
通讯作者：
Baskin DG