Overview

SMART Use of Medication for the Treatment of Adolescent Severe Obesity

Status:
Recruiting
Trial end date:
2025-08-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Minnesota
University of Minnesota - Clinical and Translational Science Institute
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Treatments:
Phentermine
Topiramate
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