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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
13
Phentermine tablet
Topiramate tablet
Compounded tablet to mimic phentermine 8mg tablet
Compounded tablet to mimic immediate release topiramate 25mg tablet
Children's Hospital Colorado
Aurora, Colorado, United States
Enrollment Rate
(Number enrolled divided by number eligible) x 100
Time frame: 6 months
Dropout Rate
Number who do not complete the study divided by number enrolled
Time frame: 24 months
Number of Participants Adherent to Study Drugs
Presence of amphetamine in the urine at any study visit
Time frame: 12 weeks
Frequency of Adverse Events
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.
Time frame: 24 months
Percent BMI Change
(Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100
Time frame: Baseline and 12 weeks
Percent Weight Change
(Baseline weight - weight at 12 weeks)/Baseline weight x 100
Time frame: Baseline and 12 weeks
Change in BMI Percent of the 95th%Ile
(Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks)
Time frame: Baseline and 12 weeks
Change in Heart Rate
(Heart rate at baseline - Heart rate at 12 weeks)
Time frame: Baseline and 12 weeks
Change in Systolic Blood Pressure
Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks
Time frame: Baseline and 12 weeks
Change in Diastolic Blood Pressure
Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks
Time frame: Baseline and 12 weeks
Change in Total Cholesterol (mg/dL)
Total cholesterol at baseline - Total cholesterol at 12 weeks
Time frame: Baseline and 12 weeks
Change in Triglycerides (mg/dL)
Triglycerides at baseline - Triglycerides at 12 weeks
Time frame: Baseline and 12 weeks
Change in LDL Cholesterol (mg/dL)
LDL at baseline - LDL at 12 weeks
Time frame: Baseline and 12 weeks
Change in HDL Cholesterol (mg/dL)
HDL at baseline - HDL at 12 weeks
Time frame: Baseline and 12 weeks
Change in Alanine Aminotransferase (ALT) (U/L)
ALT at baseline - ALT at 12 weeks
Time frame: Baseline and 12 weeks
Change in Hemoglobin A1c (HbA1c) (%)
HbA1c at baseline - HbA1c at 12 weeks
Time frame: Baseline and 12 weeks
Change in % Fat Mass
% Fat mass at baseline - %Fat mass at 12 weeks measured by DEXA
Time frame: Baseline and 12 weeks
Change in Resting Metabolic Rate (RMR)
RMR at baseline - RMR at 12 weeks measured by indirect calorimetry
Time frame: Baseline and 12 weeks
Change in Daily Kilocalorie Intake
The average kilocalorie intake of 3 days was calculated each at baseline and 12 weeks. Kilocalories were calculated based on a standardized self-reported log of two weekdays and 1 weekend day.
Time frame: Baseline and 12 weeks
Change in Hunger
The adolescent/young adult will report subjective hunger before each meal and snack for 24 hours using a visual analogue slider scale (0= no hunger, 100 = most hunger) and this score will be averaged over the 24 hour period.
Time frame: Baseline and 12 weeks
Change in Satiety
The adolescent/young adult will report subjective satiety 30 minutes after each meal and snack for 24 hours using a visual analogue slider scale (0= no fullness, 100 = most full) and this score will be averaged over the 24 hour period.
Time frame: Baseline and 12 weeks
Change in Eating in the Absence of Hunger
Validated questionnaire: Eating in the Absence of Hunger-Parent (EAH-P) completed by the parent/guardian about their adolescent/young adult. This measure has 14 items. Each item is on a 5-point Likert scale ranging from 1= "never" to 5= "always". A higher score indicates more eating in the absence of hunger. Total scores (minimum 14 to maximum 70) are calculated by taking the sum of the 14 items at each time point. The mean change in total scores by group are presented.
Time frame: Baseline and 12 weeks
Change in Cognitive Restraint
The "Three-Factor Eating Questionnaire" will be completed by the adolescent/young adult. This is a 51-item questionnaire that assesses 3 eating behaviors: Cognitive Dietary Restraint, Disinhibited Eating, and Predisposition to hunger. Cognitive restraint was the domain of highest interest for this study and is reported here. Higher scores in each domain indicate more of each of those behaviors. The cognitive restraint domain score is calculated by taking the average of the 21 items in that domain. Each of the 21 items has a score of 0 or 1. MINIMUM mean score for this measure is: 0 and MAXIMUM mean score is 1. MINIMUM total score for this measure is: 0 and MAXIMUM total score is 21 (relevant to the "Full Range" in the data table below)
Time frame: Baseline and 12 weeks
Change in Total Weight Related Quality of Life- Adolescent/Young Adult Report
"Impact of Weight on Quality of Life-Kids" questionnaire will be completed by the adolescents age \<=19. Total and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100. Higher scores indicate higher quality of life.
Time frame: Baseline and 12 weeks
Change in Total Weight Related Quality of Life- Parent Reported of Adolescent/Young Adult
"Impact of Weight on Quality of Life-Kids Parent Proxy" questionnaire will be completed by the parent of the adolescent/young adult. Total and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100. Higher scores indicate higher quality of life.
Time frame: Baseline and 12 weeks
Change in General Health Related Quality of Life: Total Score PedsQL Instrument - Self Report
PedsQL instrument will be completed by the adolescent/young adult. The CHANGE in total scale score is reported here. The total scale score at each time point ranges from a MIN of 0 to a MAX of 100. Items are rated on a 0-4 scale. Items are reverse scored and linearly transformed to a 0-100 scale, such that 0=100, 1=75, 2=50, 3=25, and 4=0. Scale Scores are calculated as the sum of the items over the number of items answered. Higher scores indicated better health-related quality of life.
Time frame: Baseline and 12 weeks
Change in Depression
The adolescent/young adult will complete the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). Each item is rated on a 0 to 3 scale (positive items are reverse scored). Minimum score is 0 and maximum is 60. Higher scores indicate more depressive symptoms. Total score is calculated by summing each of the 20 individual items scores.
Time frame: Baseline and 12 weeks
Participant Satisfaction: Questionnaire
The participating family will be asked to complete a satisfaction questionnaire that will assess reasons for participation, experience during study visits, satisfaction with the effect of the study drug, ease of communication with study staff, and study burden. The outcome presented here is the average of the parent and adolescent/young adult dyad's response to the statement: "My overall experience was positive" \[1=Strongly disagree, 5=Strongly agree\]
Time frame: At 12 weeks
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