A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Repeat Doses of Intranasal Oxytocin in Obese Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline
研究概览
简要总结
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study visits include screening to determine eligibility, a 2-part baseline visit, and visits every 2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-45 years old;
- •BMI greater than or equal to 30 kg/m2
排除标准
- •Use of drug affecting metabolism, glucose, or appetite (Metformin is allowed if dose and weight are stable for at least 3 months);
- •history of medication changes within 4 weeks of enrollment;
- •active substance use;
- •history of cardiovascular disease, gastrointestinal disorders, bariatric surgery, epilepsy, untreated thyroid disease;
- •hematocrit >2% below normal;
- •fasting glucose > 125 mg/dL or hemoglobin A1c ≥ 7% ;
- •ALT or AST >2.5 times upper limit of normal;
- •Cr >1.5 mg/dL; hyponatremia;
- •pregnancy or breastfeeding;
- •unwilling to use medically acceptable form of contraception (females only)
- •follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, Paleo, Atkins, raw diet, macrobiotic diet)
- •current smoking or tobacco use
研究组 & 干预措施
oxytocin
oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
干预措施: oxytocin nasal spray (Drug)
placebo
placebo nasal spray (4 times per day for 8 weeks)
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline
时间窗: Baseline to 8 weeks
The mean difference in weight loss between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline, Week 2, Week 4, Week 6, and Week 8) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group.
次要结局
- Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo(Baseline to 8 weeks)
- Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo(Baseline to 8 weeks)
- Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo(Baseline to 6 weeks)
研究者
Elizabeth Austen Lawson
Associate Professor of Medicine, Harvard Medical School
Massachusetts General Hospital