Clinical trial NCT04007393: SMART Use of Medication for the Treatment of Adolescent Severe Obesity
Official title: SMART Use of Medication for the Treatment of Adolescent Severe Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Adolescent Obesity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-07-05
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 2-staged sequential multiple assignment randomized trial
Primary purpose: TREATMENT

Brief summary: This study will examine the timing and sequence of using adjunct obesity pharmacotherapy for adolescents with severe obesity who do not respond to lifestyle modification therapy alone.

Detailed description: This project is studying the best time to add weight loss medication to diet and exercise for helping adolescents who carry extra weight. All participants start with a lifestyle modification program and some participants may also receive study medication.Participants must be 12-17 years of age and carry extra weight. The program will last for 48 weeks.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed assent form;
* Provision of signed and dated informed parental consent form from at least 1 legal parent/guardian;
* Stated willingness to comply with all study procedures and availability for the duration of the study;
* BMI \>/= 1.2 times the 95th percentile or BMI \>/= 35 Kg/m2, whichever is lower;
* Tanner stage \>/= 2;
* Male or female, aged 12-17 at time of consenting;
* For females of reproductive potential: when sexually active, agreement to use highly effective contraception (oral contraceptive pill, intra-uterine device (IUD), or implant) during study participation;
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

Exclusion Criteria:

* Contraindications to phentermine or topiramate use according to package inserts, including: history of glaucoma; current or recent (\< 14 days) use of monoamine oxidase inhibitor; known hypersensitivity to sympathomimetic amines; current pregnancy, plans to become pregnant, or if sexually active refusal to use 2 forms of birth control; history of cardiac disease including coronary artery disease; clinically significant cardiac arrhythmias; heart failure or uncontrolled hypertension;
* Diabetes (type 1 or 2);
* Presence of cardiac pacemaker;
* Current or recent (\<6 months prior to enrollment) use of weight loss medication(s);
* Current use of weight-altering medication(s) (e.g., atypical antipsychotic, metformin) unless dose has been stable for past 6 months;
* Current use of other sympathomimetic amine such as attention-deficit hyperactivity disorder (ADHD) stimulants;
* Seizure disorder (other than infantile febrile seizure);
* Previous bariatric surgery;
* Recent initiation of change in dose (\< 3 months prior to enrollment) of anti-hypertensive or lipid medication(s);
* Tobacco use
* History of or current diagnosis of schizophrenia, psychosis, mania, chemical dependency;
* Unstable depression or anxiety that has required hospitalization in the past year;
* Any history of suicide attempt;
* Suicidal ideation or self-harm within 12 months prior to enrollment;
* Bicarbonate \< 18 mmol/L;
* Creatinine \> 1.2 mg/dL;
* History of cholelithiasis;
* History of nephrolithiasis;
* Untreated thyroid disorder;
* Hyperthyroidism;
* Breastfeeding

Primary outcomes:
measure: Percent change in body mass index (BMI)
timeFrame: Baseline, 12-, 24-, 36-, and 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Claudia Fox, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: