- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04095104
Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults After Bariatric Surgery: A Randomized Controlled Pilot Study
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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) |
Phentermine tablet
Other Names:
Topiramate tablet
Other Names:
|
Placebo Comparator: 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) |
Compounded tablet to mimic phentermine 8mg tablet
Compounded tablet to mimic immediate release topiramate 25mg tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enrollment Rate
Time Frame: 24 months
|
Number enrolled divided by number eligible
|
24 months
|
Dropout Rate
Time Frame: 24 months
|
Number who do not complete the study divided by number enrolled
|
24 months
|
Adherence to Study Drugs
Time Frame: 12 weeks
|
Percentage of missed doses (pill count); Presence/Absence of amphetamine in the urine
|
12 weeks
|
Frequency of drug-related adverse events
Time Frame: 24 months
|
Count and description of adverse events possibly or definitely related to the study drugs.
Elicited using a standardized checklist during 3 study phone calls and 3 in-person study visits, laboratory monitoring of serum bicarbonate, and comprehensive review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent weight change
Time Frame: Baseline and 12 weeks
|
(Baseline weight - Weight at 12 weeks)/Baseline weight x 100
|
Baseline and 12 weeks
|
Percent BMI change
Time Frame: Baseline and 12 weeks
|
(Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100
|
Baseline and 12 weeks
|
Change in BMI percent of the 95th%ile
Time Frame: Baseline and 12 weeks
|
(Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks)
|
Baseline and 12 weeks
|
Change in heart rate
Time Frame: Baseline and 12 weeks
|
(Heart rate at baseline - Heart rate at 12 weeks)
|
Baseline and 12 weeks
|
Change in systolic blood pressure
Time Frame: Baseline and 12 weeks
|
Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks
|
Baseline and 12 weeks
|
Change in diastolic blood pressure
Time Frame: Baseline and 12 weeks
|
Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks
|
Baseline and 12 weeks
|
Change in total cholesterol (mg/dL)
Time Frame: Baseline and 12 weeks
|
Total cholesterol at baseline - Total cholesterol at 12 weeks
|
Baseline and 12 weeks
|
Change in triglycerides (mg/dL)
Time Frame: Baseline and 12 weeks
|
Triglycerides at baseline - Triglycerides at 12 weeks
|
Baseline and 12 weeks
|
Change in LDL cholesterol (mg/dL)
Time Frame: Baseline and 12 weeks
|
LDL at baseline - LDL at 12 weeks
|
Baseline and 12 weeks
|
Change in HDL cholesterol (mg/dL)
Time Frame: Baseline and 12 weeks
|
HDL at baseline - HDL at 12 weeks
|
Baseline and 12 weeks
|
Change in alanine aminotransferase (ALT) (U/L)
Time Frame: Baseline and 12 weeks
|
ALT at baseline - ALT at 12 weeks
|
Baseline and 12 weeks
|
Change in hemoglobin A1c (HbA1c) (%)
Time Frame: Baseline and 12 weeks
|
HbA1c at baseline - HbA1c at 12 weeks
|
Baseline and 12 weeks
|
Change in % fat mass
Time Frame: Baseline and 12 weeks
|
% Fat mass at baseline - %Fat mass at 12 weeks measured by DEXA
|
Baseline and 12 weeks
|
Change in resting metabolic rate (RMR)
Time Frame: Baseline and 12 weeks
|
RMR at baseline - RMR at 12 weeks measured by indirect calorimetry
|
Baseline and 12 weeks
|
Change in Dietary Intake
Time Frame: Baseline and 12 weeks
|
The adolescent/young adult will complete a dietary record on 3 consecutive days (2 weekdays, 1 weekend day) based on standardized protocols for dietary assessment.
Total caloric intake, macronutrient, and micronutrient breakdown will be assessed.
|
Baseline and 12 weeks
|
Change in Hunger
Time Frame: Baseline and 12 weeks
|
The adolescent/young adult will report hunger before each meal and snack for 24 hours using a 100mm visual analogue scale (0= no hunger, 100 = most hunger)
|
Baseline and 12 weeks
|
Change in Satiety
Time Frame: Baseline and 12 weeks
|
The adolescent/young adult will report satiety before each meal and snack for 24 hours using a 100mm visual analogue scale (0= no fullness, 100= most full)
|
Baseline and 12 weeks
|
Change in Eating in the Absence of Hunger
Time Frame: Baseline and 12 weeks
|
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 and sub scales are calculated by taking the average of the items. Total score measures the overall construct "Eating in the Absence of Hunger" Subscales include: "External Cues" (4 items); "Response to negative affect" (6 items); "Fatigue/Boredom" (4 items). |
Baseline and 12 weeks
|
Change in Cognitive Restraint, Disinhibited Eating, and Predisposition to Hunger
Time Frame: Baseline and 12 weeks
|
The "Three-Factor Eating Questionnaire" will be completed by the adolescent/young adult. This is a 51-item measure that is divided into 2 parts, and assesses 3 eating behaviors: 1) Cognitive Dietary Restraint (20 items), 2) Disinhibited Eating (16 items), and 3) Predisposition to hunger (15 items). Higher scores in each domain indicate more of each of those behaviors. The minimum score for factors 1, 2, and 3 are: 0, 0, and 0. The maximum score for factors 1, 2, and 3 are: 20, 16, and 15 Part I includes items 1-36 rated as either True (1) or False (0) Part II includes items 37-51 and is rated on a 4-point Likert-like scale with one exception- item 50 is rated on a 6-point scale. Scores for each of the three eating behaviors are calculated by taking the average of the items, and are most commonly reported separately, not as a total score. |
Baseline and 12 weeks
|
Change in Weight Related Quality of Life- Adolescent
Time Frame: Baseline and 12 weeks
|
"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. |
Baseline and 12 weeks
|
Change in Weight Related Quality of Life- Parent
Time Frame: Baseline and 12 weeks
|
"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. |
Baseline and 12 weeks
|
Change in Weight Related Quality of Life- Young adult
Time Frame: Baseline and 12 weeks
|
"Impact of Weight on Quality of Life-Lite" questionnaire will be completed by the young adult age >=20. Total and each of the 5 sub scales (Physical function-11 items, Self Esteem-7 items, Sexual Life-4 items, Public distress-5 items, and Work-4 items) range from a minimum score of 0 to a maximum of 100. Higher scores indicate higher quality of life. |
Baseline and 12 weeks
|
Change in General Health Related Quality of Life: PedsQL instrument
Time Frame: Baseline and 12 weeks
|
PedsQL instrument will be completed by the adolescent/young adult. There are 4 scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items) and 3 Summary Scores: Total Scale Score (23 items), Physical Health Summary Score (8 items), and Psychosocial Health Summary Score (15 items). 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. Higher scores indicated better health-related quality of life. Scale Scores are calculated as the sum of the items over the number of items answered. Psychosocial Health Summary Score is calculated as the sum of the items over the number of items answered in the Emotional, Social, and School Functioning Scales. Physical Health Summary Score is the same as the Physical Functioning Scale Score. |
Baseline and 12 weeks
|
Change in Depression
Time Frame: Baseline and 12 weeks
|
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. |
Baseline and 12 weeks
|
Participant Satisfaction: questionnaire
Time Frame: At 12 weeks
|
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.
|
At 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jaime M Moore, MD, MPH, University of Colorado School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Obesity
- Obesity, Morbid
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anticonvulsants
- Appetite Depressants
- Anti-Obesity Agents
- Central Nervous System Stimulants
- Sympathomimetics
- Topiramate
- Phentermine
Other Study ID Numbers
- 18-2793
- 5P30DK048520-24 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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