Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults After Bariatric Surgery: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Enrollment Rate
研究概览
简要总结
The goal of this pilot study is to establish the feasibility and initial efficacy of the combination of phentermine and topiramate for adolescents and young adults who require additional risk reduction after bariatric surgery. This study will use a randomized, placebo-controlled, double-blinded design to evaluate an adjunctive 12-week intervention of phentermine + topiramate + standard of care vs. placebos + standard of care 6 months after bariatric surgery, among 12 to 24 year olds who don't achieve expected weight loss or who remain severely obese (n=10 total).
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)
盲法说明
At baseline, each participant will be randomized 1:1 to either 12 weeks of phentermine, topiramate and standard of care or 12 weeks of phentermine placebo, topiramate placebo, and standard of care. This randomization will be blinded to the participant, investigator, care providers, and outcomes assessor for the duration of the study.
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Status post sleeve gastrectomy or roux-en-y gastric bypass
- •At 6 months after bariatric surgery, has not achieved >= 26% decrease in weight from preoperative weight (within 1 week of surgery) OR remains severely obese (>=120% of 95th%ile or BMI >=35kg/m2 for 12-17yo; BMI >=35kg/m2 for 18-24yo)
排除标准
- •Absolute contraindication to phentermine or topiramate (i.e. phentermine:
- •history of coronary artery disease, stroke, arrhythmia, congestive heart failure, uncontrolled hypertension), hypersensitivity to sympathomimetic amines, current or recent (within 14 days) use of monoamine oxidase inhibitors, glaucoma, or hyperthyroidism; topiramate: hypersensitivity to topiramate, history of nephrolithiasis)
- •Concomitant use of phenytoin, carbamazepine, or carbonic anhydrase inhibitors (e.g. zonisamide, acetazolamide, or dichlorphenamide)
- •Use of anti-obesity medication within 6 months of screening
- •Initiation of a new medication associated with weight loss or gain within 30 days of screening
- •Type 2 diabetes mellitus
- •Hypothalamic obesity
- •Unmanaged (e.g. without medications and/or psychotherapy) clinically significant (determined by a mental health professional using diagnostic instruments and/or clinical interview) depression or anxiety
- •History of any suicidal behavior within 30 days of screening or any suicidal ideation with either some intent to act or with intent and a specific plan within 30 days of screening
- •History of schizophrenia
- •Severe hepatic impairment (ALT >10x upper limit of normal or known synthetic liver dysfunction)
- •Moderate or severe renal impairment (GFR <30mL/min/1.73m2)
- •Dosage change to hypertension, dyslipidemia, depression, or anxiety medication <4 weeks prior to study enrollment
- •Contraception started <7 days prior to study enrollment
- •Current pregnancy/plans to become pregnant within 16 weeks from study drug start date
- •Females without a long acting reversible contraceptive (LARC) who do not commit to using 2 forms of birth control
研究组 & 干预措施
Phentermine & Topiramate
Phentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration:
4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning
Immediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning
Standard of Care (multidisciplinary postoperative bariatric surgery clinic visits)
干预措施: Phentermine (Drug)
Phentermine & Topiramate
Phentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration:
4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning
Immediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning
Standard of Care (multidisciplinary postoperative bariatric surgery clinic visits)
干预措施: Immediate Release Topiramate (Drug)
Placebo Drugs
Placebo Phentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration: 4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning
Placebo Immediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning
Standard of Care (multidisciplinary postoperative bariatric surgery clinic visits)
干预措施: Placebo for Phentermine (Drug)
Placebo Drugs
Placebo Phentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration: 4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning
Placebo Immediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning
Standard of Care (multidisciplinary postoperative bariatric surgery clinic visits)
干预措施: Placebo for Immediate Release Topiramate (Drug)
结局指标
主要结局
Enrollment Rate
时间窗: 6 months
(Number enrolled divided by number eligible) x 100
Dropout Rate
时间窗: 24 months
Number who do not complete the study divided by number enrolled
Number of Participants Adherent to Study Drugs
时间窗: 12 weeks
Presence of amphetamine in the urine at any study visit
Frequency of Adverse Events
时间窗: 24 months
Unique adverse events documented prior to unblinding. Adverse events were elicited using a standardized checklist during study phone calls and in-person study visits, laboratory monitoring, review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit.
次要结局
- Change in Total Cholesterol (mg/dL)(Baseline and 12 weeks)
- Change in Triglycerides (mg/dL)(Baseline and 12 weeks)
- Change in LDL Cholesterol (mg/dL)(Baseline and 12 weeks)
- Change in HDL Cholesterol (mg/dL)(Baseline and 12 weeks)
- Change in Alanine Aminotransferase (ALT) (U/L)(Baseline and 12 weeks)
- Percent BMI Change(Baseline and 12 weeks)
- Percent Weight Change(Baseline and 12 weeks)
- Change in BMI Percent of the 95th%Ile(Baseline and 12 weeks)
- Change in Hemoglobin A1c (HbA1c) (%)(Baseline and 12 weeks)
- Change in % Fat Mass(Baseline and 12 weeks)
- Change in Resting Metabolic Rate (RMR)(Baseline and 12 weeks)
- Change in Heart Rate(Baseline and 12 weeks)
- Change in Systolic Blood Pressure(Baseline and 12 weeks)
- Change in Diastolic Blood Pressure(Baseline and 12 weeks)
- Change in Daily Kilocalorie Intake(Baseline and 12 weeks)
- Change in Hunger(Baseline and 12 weeks)
- Change in Satiety(Baseline and 12 weeks)
- Change in Eating in the Absence of Hunger(Baseline and 12 weeks)
- Change in Cognitive Restraint(Baseline and 12 weeks)
- Change in Total Weight Related Quality of Life- Adolescent/Young Adult Report(Baseline and 12 weeks)
- Change in Total Weight Related Quality of Life- Parent Reported of Adolescent/Young Adult(Baseline and 12 weeks)
- Change in General Health Related Quality of Life: Total Score PedsQL Instrument - Self Report(Baseline and 12 weeks)
- Change in Depression(Baseline and 12 weeks)
- Participant Satisfaction: Questionnaire(At 12 weeks)