Clinical trial NCT04095104: Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
Official title: Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults After Bariatric Surgery: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity, Morbid
Bariatric Surgery
Adolescent
Young Adult
Drug Therapy
Keywords: Pilot
Feasibility
Initial Efficacy
Randomized Controlled Trial
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Colorado- Clinical and Translational Sciences Institute
name: University of Colorado- Nutrition Obesity Research Center
First posted: 2019-09-19
Enrollment: 13
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel assignment where the experimental arm will receive active drugs + standard of care and the control arm will receive placebo drugs + standard of care.
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Enrollment Rate
timeFrame: 6 months
measure: Dropout Rate
timeFrame: 24 months
measure: Number of Participants Adherent to Study Drugs
timeFrame: 12 weeks
measure: Frequency of Adverse Events
timeFrame: 24 months
Secondary outcomes:
measure: Percent BMI Change
timeFrame: Baseline and 12 weeks
measure: Percent Weight Change
timeFrame: Baseline and 12 weeks
measure: Change in BMI Percent of the 95th%Ile
timeFrame: Baseline and 12 weeks
measure: Change in Heart Rate
timeFrame: Baseline and 12 weeks
measure: Change in Systolic Blood Pressure
timeFrame: Baseline and 12 weeks
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline and 12 weeks
measure: Change in Total Cholesterol (mg/dL)
timeFrame: Baseline and 12 weeks
measure: Change in Triglycerides (mg/dL)
timeFrame: Baseline and 12 weeks
measure: Change in LDL Cholesterol (mg/dL)
timeFrame: Baseline and 12 weeks
measure: Change in HDL Cholesterol (mg/dL)
timeFrame: Baseline and 12 weeks
measure: Change in Alanine Aminotransferase (ALT) (U/L)
timeFrame: Baseline and 12 weeks
measure: Change in Hemoglobin A1c (HbA1c) (%)
timeFrame: Baseline and 12 weeks
measure: Change in % Fat Mass
timeFrame: Baseline and 12 weeks
measure: Change in Resting Metabolic Rate (RMR)
timeFrame: Baseline and 12 weeks
measure: Change in Daily Kilocalorie Intake
timeFrame: Baseline and 12 weeks
measure: Change in Hunger
timeFrame: Baseline and 12 weeks
measure: Change in Satiety
timeFrame: Baseline and 12 weeks
measure: Change in Eating in the Absence of Hunger
timeFrame: Baseline and 12 weeks
measure: Change in Cognitive Restraint
timeFrame: Baseline and 12 weeks
measure: Change in Total Weight Related Quality of Life- Adolescent/Young Adult Report
timeFrame: Baseline and 12 weeks
measure: Change in Total Weight Related Quality of Life- Parent Reported of Adolescent/Young Adult
timeFrame: Baseline and 12 weeks
measure: Change in General Health Related Quality of Life: Total Score PedsQL Instrument - Self Report
timeFrame: Baseline and 12 weeks
measure: Change in Depression
timeFrame: Baseline and 12 weeks
measure: Participant Satisfaction: Questionnaire
timeFrame: At 12 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine
name: Jaime M Moore, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: