NCT03497988撤回2 期
Effect of a Single Dose of Intranasal Oxytocin on Food Intake in Obese Adolescents
Shana McCormack, MD0 个研究点开始时间: 2018年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Effect on Food Intake
研究概览
简要总结
The purpose of the study is to determine the effect of intranasal OXT caloric intake and eating behaviors in otherwise healthy obese adolescents.
The primary objective of this study is to determine the effects of intranasal administration of oxytocin on food intake in obese, pubertal or post-pubertal adolescents (13 to <18 years in girls, and 15 to <20 years in boys).
详细描述
Participants will undergo a telephone screening and then, within 4 weeks, complete an in-person screening visit to determine eligibility. Then, within 4 weeks they will be randomized to either OXT or placebo. After a minimum 1-week (7-28 days) "washout," participants will cross-over to treatment with the other condition (i.e., placebo or OXT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proficient in English.
- •Pubertal or Post-Pubertal Females: 13 to <18 years.
- •Pubertal or Post-Pubertal Males: 15 to <20 years.
- •Girls must have a negative urine pregnancy test and post-menarchal girls must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
- •Currently obese (BMI >95%ile for age/sex if age < 18 years, BMI > 30 kg/m2 age 18 - 20 years). In children, obesity is defined with respect to age- and sex based as greater than or equal to the 95th%ile1, whereas in adults, an absolute threshold is used.
- •Parental/guardian permission (informed consent) and if appropriate, child assent.
排除标准
- •Diabetes mellitus requiring insulin or insulin secretagogue. (Laboratory values: HgbA1c ≥8.5%)
- •Cardiovascular condition, as defined as any of the following: i) abnormal blood pressure, defined as <3%ile or >97%ile for age, sex and height 3, for adult participants abnormal blood pressure is defined as Stage 2 hypertension (systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg); ii) history of cardiac arrhythmia or arrhythmia detected on screening ECG; iii) history of heart failure and/or cardiomyopathy; iv) prolonged QTc interval (QTc > 460 msec), and/or long QT syndrome phenotype and/or positive genotype for long QT syndrome pathogenic mutations.
- •Concurrent use of medications known to prolong QTc interval and pose high risk for Torsades de Pointes (TdP) according to the current information available (www.crediblemeds.org). Concomitant medications will be assessed by the Investigational Drug Service (IDS) pharmacist, in collaboration with the study cardiologist, if additional clarification is needed. In addition, we require that potential participants be on a stable dose for at least 2 months of any medication with the potential to alter cardiac rhythm to ensure the screening ECG reflects steady-state physiology.
- •Laboratory abnormalities that indicate abnormal sodium level, liver or renal disease, or anemia:
- •Sodium - Outside Normal Range; Aspartate Aminotransferase (AST)/SGOT > 3.0 X's Upper Limit of Normal (ULN); Alanine Aminotransferase (ALT)/SGPT > 3.0 X's Upper Limit of Normal (ULN); Estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73m2; Hemoglobin < 10 g/dL
- •Seizure in the past 12 mos.
- •History of gastrectomy, gastric bypass, small or large bowel resection.
- •History of active substance abuse.
- •Current use of psychiatric medications. Current psychotic disorder and/or suicidality.
- •Other chronic medical conditions or medications likely to affect appetite or food intake.
- •Any investigational drug use within 30 days prior to enrollment.
- •Pregnant or lactating females.
- •Inability to take intranasal medication (e.g., recent injury)
- •Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
研究组 & 干预措施
Syntocinon (=Oxytocin), then Placebo
Experimental
- Single-Dose Intranasal Oxytocin
- Single-Dose Placebo
干预措施: Syntocinon (Drug)
Syntocinon (=Oxytocin), then Placebo
Experimental
- Single-Dose Intranasal Oxytocin
- Single-Dose Placebo
干预措施: Placebo (Drug)
Placebo, then Syntocinon (=Oxytocin)
Experimental
- Single-Dose Placebo
- Single-Dose Intranasal Oxytocin
干预措施: Syntocinon (Drug)
Placebo, then Syntocinon (=Oxytocin)
Experimental
- Single-Dose Placebo
- Single-Dose Intranasal Oxytocin
干预措施: Placebo (Drug)
结局指标
主要结局
Effect on Food Intake
时间窗: 28 Days
Kilocalories Consumed at as desired ('Ad Lib') Test Meal
次要结局
- Effect of OXT on Eating Behaviors at Mealtime (appetite)(28 Days)
- Adverse Events(28 Days)
- Effect of OXT on Eating Behaviors at Mealtime (impulsivity)(28 Days)
研究者
Shana McCormack, MD
Attending Physician, Sponsor Investigator
Children's Hospital of Philadelphia
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