Dataset Information

A Pilot Randomized Clinical Trial of Intranasal Oxytocin to Promote Weight Loss in Individuals With Hypothalamic Obesity.

ABSTRACT:

Context

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.

Objective

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.

Methods

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.

Results

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.

Conclusion

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.

SUBMITTER: McCormack SE

PROVIDER: S-EPMC10154909 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Pilot Randomized Clinical Trial of Intranasal Oxytocin to Promote Weight Loss in Individuals With Hypothalamic Obesity.

McCormack Shana E SE Wang Zi Z Wade Kristin L KL Dedio Anna A Cilenti Nicolette N Crowley Julia J Plessow Franziska F Bamba Vaneeta V Roizen Jeffrey D JD Jiang Yaoguang Y Stylli Jack J Ramakrishnan Arjun A Platt Michael L ML Shekdar Karuna K Fisher Michael J MJ Vetter Victoria L VL Hocking Matthew M Xiao Rui R Lawson Elizabeth A EA

Journal of the Endocrine Society 20230317 5

<h4>Context</h4>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.<h4>Objective</h4>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.<h4>Methods</h4>This randomized, double-blind, placebo-controlled, crossover pilot trial (NCT02849743), conducted at an ...[more]

PMID: 37153702

Similar Datasets

Project description:ObjectivesObesity is associated with sarcopenia in older adults, and weight loss can lead to further muscle mass loss. Oxytocin decreases with age, and animal studies suggest that oxytocin administration has trophic effects on skeletal muscle cells and reduces adiposity. We conducted a clinical trial to examine the safety and preliminary efficacy of intranasal oxytocin for older adults with sarcopenic obesity.DesignA double-blind, placebo-controlled randomized controlled trial of intranasal oxytocin (24 IU 4 times per day) for 8 weeks.Setting and participantsTwenty-one older (67.5 ± 5.4 years), obese (30-43 kg/m2), sedentary (<2 strenuous exercise per week) adults with slow gait speed (<1 m/s, proxy measure of sarcopenia) were recruited.MeasuresGeneralized estimating equations were used to evaluate the effect of oxytocin on safety/tolerability of oxytocin administration and whole body muscle and fat mass.ResultsAt baseline, body mass index (BMI) was 36.8 ± 3.6 kg/m2, fat mass 46.09 ± 6.99 kg, lean mass 50.98 ± 11.77 kg, fasting plasma glucose (FPG) 92.0 ± 8.9 mg/dL, hemoglobin A1c (HbA1c) 5.7% ± 0.4%, low density lipoprotein (LDL) 111.3 ± 41.5 mg/dL, high-density lipoprotein (HDL) 47.85 ± 10.96 mg/dL, and triglycerides 140.55 ± 83.50 mg/dL. Oxytocin administration was well tolerated without any significant adverse events. Oxytocin led to a significant increase of 2.25 kg in whole body lean mass compared with placebo (P < .01) with a trend toward decreasing fat mass, and a significantly reduced plasma LDL cholesterol by -19.3 mg/dL (P = .023) compared against placebo. There were no significant changes in BMI, appetite scores, glycemia, plasma HDL, triglycerides, or depressive symptoms.Conclusions and implicationsThis proof-of-concept study indicates that oxytocin may be useful for the treatment of sarcopenic obesity in older adults. Oxytocin administration may also provide additional cardiovascular benefits.

Project description:BackgroundIndividuals diagnosed with serious mental illnesses are at increased risk of obesity- and cardiovascular-related morbidity and early mortality. Lifestyle interventions aimed at weight loss, even those adapted to suit the needs of this particular subgroup, have rarely produced clinically meaningful reductions in weight.Methods/designThe STRIDE study is a multi-site, parallel, two-arm randomized controlled translational trial. Participants were recruited from community mental health clinics and an integrated not-for-profit health system. Participants were randomized either to usual care or to a 12-month intervention that consisted of: 1) weekly group participation for six months covering topics on nutrition, physical activity and lifestyle changes; 2) monthly group participation for an additional six month maintenance period; and 3) individual monthly contacts from intervention group facilitators during the second six month phase. All participants are assessed at baseline, 6, 12, and 24 months post-enrollment. Process and implementation evaluations are included and the study design includes a cost-utility analysis. Participants include 200 individuals with serious mental illness with an average age of 47.1 years, a mean body-mass index of 38.3 kg/m(2) and taking an average of 3.2 psychiatric medications at baseline. Baseline physiological measures included mean blood pressure (SBP/DBP) measurements of 119.2 (SD = 14.7)/79.4 (SD = 10.1); 35% reported a hypertension diagnosis and 11% took antihypertensive medications. Average lipid levels (mg/dL) were: a) triglycerides 188.0 (SD = 138.6), ranged from 43 to 1145; b) LDL 101.4 (SD = 32.9) and ranged from 17 to 185; c) HDL 45.8 (SD = 12.7) and ranged from 22 to 89; and d) total cholesterol 181.6 (SD = 39.7) and ranged from 50 to 324. Average fasting glucose levels were 108.9 (SD = 32.5) and ranged from 24 to 289. Average fasting insulin levels were 13.0 (SD=11.9) and ranged from 2 to 99.DiscussionThe STRIDE study is based on a modified version of the PREMIER comprehensive lifestyle intervention, DASH diet arm. STRIDE has successfully enrolled 200 individuals with serious mental illness in community-based settings. Baseline characteristics present a population at high risk for obesity-related negative health outcomes and demonstrate the need for evidence-based interventions to reduce these risks.Trial registrationClinical Trials.gov NCT00790517.

Dataset Information

A Pilot Randomized Clinical Trial of Intranasal Oxytocin to Promote Weight Loss in Individuals With Hypothalamic Obesity.

Context

Objective

Methods

Results

Conclusion

Publications

A Pilot Randomized Clinical Trial of Intranasal Oxytocin to Promote Weight Loss in Individuals With Hypothalamic Obesity.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets