Oxytocin as a Neuroendocrine Therapy for Obesity in Youth
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Body mass index (BMI)
研究概览
简要总结
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 10-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray per nostril, 4 times per day) for 12 weeks. Study visits include screening to determine eligibility, 2-part main study visits at baseline, week 8, and week 12, and safety check-in visits at weeks 1, and 4; phone calls at weeks 2, 6, and 10, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.
详细描述
In recent years there has been a dramatic increase in obesity and its complications in both children and adults. Earlier treatment substantially reduces the likelihood of developing complications later in life while concurrently improving quality of life and decreasing mortality. Therefore, it is essential to develop safe and effective therapeutic strategies for weight loss, particularly in adolescents. Oxytocin (OXT), a hypothalamic peptide hormone that regulates energy balance, is a novel neuroendocrine weight-loss therapeutic in adults with obesity because it simultaneously reduces energy intake and increases energy expenditure and is well-tolerated. Data are currently lacking regarding effects of OXT administration in adolescents with obesity.
The current study is a 12-week randomized controlled trial (RCT) of OXT vs. placebo in 10-18-year old adolescents with obesity. We hypothesize that OXT administration will decrease weight as a consequence of decreased caloric intake and increased energy expenditure, both partially mediated by reduced hypothalamic inflammation (such inflammation drives weight gain by increasing food intake and reducing energy expenditure). Further, OXT will improve metabolic risk markers, such as visceral and intrahepatic fat, systemic inflammation, and serum lipids.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females, 10-18 years
- •Obesity (BMI ≥95th percentile for age and gender)
- •Willingness to maintain current diet and lifestyle for the duration of study participation
排除标准
- •Current substance abuse
- •Use of prescription or over-the-counter drugs or dietary/herbal supplements that may affect weight if dose increased in the three months preceding the baseline visit and/or if they plan to increase the dose during the 18 weeks of study participation.
- •Greater than 5kg weight loss over 3 months;
- •Follows a nonstandard diet (e.g., Paleo, Atkins, raw diet, macrobiotic diet)
- •Cardiovascular disease
- •Prolonged QT interval
- •Chronic inflammatory bowel disease and other inflammatory conditions
- •TSH > 2.5 times upper limit of normal
- •Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times upper limit of normal
- •Creatinine >1.5 mg/dl
- •Hyponatremia
- •Pregnancy/breastfeeding or refusal to use contraception not containing estrogen throughout the study if female and sexually active
- •MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clips
- •Weight >450 lbs due to limits for MRI and DXA scanners
- •Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c >8%
- •Active eating disorder
研究组 & 干预措施
Oxytocin
Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
干预措施: Oxytocin nasal spray (Drug)
Placebo
Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
干预措施: Placebo (Drug)
结局指标
主要结局
Body mass index (BMI)
时间窗: 12 weeks
Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2
Weight
时间窗: 12 weeks
Mean difference in weight between Oxytocin and Placebo group after 12 weeks of treatment
Height
时间窗: Baseline
Measure height on a stadiometer to the nearest 0.1 cm
次要结局
- Lean mass and Fat mass(12 weeks)
- Fasting Resting Energy Expenditure (kCal)(12 weeks)
研究者
Elizabeth Austen Lawson
Associate Professor
Massachusetts General Hospital