The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
Obesity is highly prevalent in older adults and is a major cause of sarcopenia and disability in older adults. Although exercise can counteract the effects of obesity and sarcopenia, many have difficulty adhering to an exercise program and the benefits of exercise are variable. Therefore, there is an urgent need to test novel pharmacologic interventions to prevent disability and loss of independence. Oxytocin is a pituitary hormone released during parturition and lactation that is also known to suppress appetite in rodents and humans; and, recent small studies have found that intranasal oxytocin reduces body weight in adults. We propose a pilot study of intranasal oxytocin as a novel approach to promote weight loss and increase muscle mass in older subjects with sarcopenic obesity.
详细描述
The pilot study will be conducted at 3 sites in 9 visits over a period of 12+ weeks. Older sedentary subjects will be screened for sarcopenic obesity using a modified consensus definition and evaluated at baseline for safety labs, glucose tolerance, body composition, cognition and physical performance, as well as systemic inflammatory markers in blood and muscle tissue.
Eligible subjects self-administer 24 IU intranasal oxytocin four times a day for 8 weeks.
The study will examine whether the intervention will promote weight loss and preserve muscle mass, thereby preserving and/or improving physical function in older subjects with sarcopenic obesity.
Generalized linear mixed effects model will be used to evaluate the effect of oxytocin on the change of each continuous measure. The effect of oxytocin will be assessed by whether the time by oxytocin interaction is significantly different from 0 with a 2-sided p-value<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 30-40 kg/m2
- •Sedentary (< 2 strenuous exercise/week)
- •Gait speed < 1 meter/second
排除标准
- •Diabetes (ADA criteria)
- •Heart disease (MI or New York Heart Classification grade III-IV)
- •Poorly controlled hypertension (SBP > 170 or DBP >95 mm/Hg)
- •Anemia (Hematocrit <34%)
- •Renal Disease (Serum Creatinine >1.4, abnormal serum sodium levels, abnormal urinalysis, or physical exam findings indicative of fluid imbalance; individuals with underlying disorder of sodium/water balance, such as SIADH, diabetes insipidus, or psychogenic polydipsia)
- •Liver Disease (AST/ALT/AlkPhos > 2x upper limit of normal)
- •Use of systemic steroid, androgens, or anti-coagulants
- •Active/unstable conditions: inflammatory, thyroid, autoimmune, gastrointestinal (GI), hematologic, or neoplastic disorders
- •Individuals with underlying seizure disorder or underlying neurologic disorder that increases seizure risk
- •Cognitive impairment (MiniCog <3), unstable mental illness, substance abuse, or history of eating disorder
研究组 & 干预措施
Oxytocin nasal spray
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
干预措施: Oxytocin nasal spray (Drug)
Placebo nasal spray
Placebo nasal spray, 4x a day for 8 weeks, self administered
干预措施: Placebo nasal spray (Drug)
结局指标
主要结局
Change in Body Weight
时间窗: Baseline to 8 weeks
Intranasal oxytocin will promote weight loss and preserve muscle mass
次要结局
- Change in Triglycerides(Baseline to 8 weeks)
- Change in Body Mass Index(8 weeks)
- Change in HbA1c (Hemoglobin A1c)(Baseline to 8 weeks)
- Change in Waist Circumference(Baseline to 8 weeks)
- Change in High Density Lipoproteins (HDL)(Baseline to 8 weeks)
- Change in Fat Mass(Baseline to 8 weeks)
- Change in Glucose Levels Measured Using the Glucose Tolerance Test(8 weeks)
- Change in Total Cholesterol(Baseline to 8 weeks)
- Change in Short Physical Performance Battery (SPPB)(Baseline to 8 weeks)
- Change in Low Density Lipoproteins (LDL)(Baseline to 8 weeks)
- Change in Center for Epidemiologic Studies Scale (CES-D)(Baseline to 8 weeks)
- Change in Montreal Cognitive Assessment (MoCA)(Baseline to 8 weeks)
研究者
Sara Espinoza
Associate Professor of Medicine
The University of Texas Health Science Center at San Antonio