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Medication + Lifestyle Changes for Adolescent Severe Obesity (SMART Trial)

Phase 2
Waitlist Available
Led By Claudia Fox, MD, MPH
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI >/= 1.2 times the 95th percentile or BMI >/= 35 Kg/m2, whichever is lower
Male or female, aged 12-17 at time of consenting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12-, 24-, 36-, and 48 weeks
Awards & highlights

SMART Trial Summary

This trial will study when and how to best use obesity medication for teens who are severely obese and haven't responded to other weight loss methods.

Who is the study for?
This trial is for teens aged 12-17 with severe obesity who haven't improved with lifestyle changes alone. They must be willing to use effective contraception if sexually active, and commit to the study's duration. Exclusions include diabetes, heart conditions, certain mental health issues, untreated thyroid disorders, previous weight loss surgery or medication use.Check my eligibility
What is being tested?
The study tests how well adding obesity drugs Phentermine and Topiramate works after lifestyle modification therapy in adolescents. It looks at the best timing and sequence for introducing these medications when lifestyle changes aren't enough.See study design
What are the potential side effects?
Possible side effects of Phentermine may include increased blood pressure and heart rate, insomnia, dizziness, and restlessness. Topiramate can cause tingling sensations, taste alterations, weight loss itself as a side effect (which could be intended here), fatigue or depression.

SMART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is at or above the lower of 1.2 times the 95th percentile or 35 Kg/m2.
Select...
I am between 12 and 17 years old.
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My body shows signs of puberty beyond the very beginning stage.

SMART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12-, 24-, 36-, and 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12-, 24-, 36-, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change in body mass index (BMI)

SMART Trial Design

2Treatment groups
Experimental Treatment
Group I: LSMT x 24 weeksExperimental Treatment3 Interventions
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at T=24 weeks: if body mass index (BMI) is down 5% at T=24 weeks, the participant will continue with LSMT for the remainder of the study (i.e. for another 24 weeks); if BMI is not down 5% at T=24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at T=36 weeks. At T=36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study (i.e. for another 12 weeks); if BMI is not down by 5% at T=36 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study (i.e. for another 12 weeks).
Group II: LSMT x 12 weeksExperimental Treatment3 Interventions
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at T=12 weeks: if body mass index (BMI) is down 5% at T=12 weeks, the participant will continue with LSMT for the remainder of the study (i.e. for another 36 weeks); if BMI is not down 5% at T=12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at T=24 weeks. At T=24 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study (i.e. for another 24 weeks); if BMI is not down by 5% at T=24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study (i.e. for another 24 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phentermine
FDA approved

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,377 Previous Clinical Trials
1,588,146 Total Patients Enrolled
69 Trials studying Obesity
20,599 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,314,916 Total Patients Enrolled
446 Trials studying Obesity
588,788 Patients Enrolled for Obesity
Claudia Fox, MD, MPHPrincipal InvestigatorUniversity of Minnesota

Media Library

LSMT x 24 weeks Clinical Trial Eligibility Overview. Trial Name: NCT04007393 — Phase 2
Obesity Research Study Groups: LSMT x 24 weeks, LSMT x 12 weeks
Obesity Clinical Trial 2023: LSMT x 24 weeks Highlights & Side Effects. Trial Name: NCT04007393 — Phase 2
LSMT x 24 weeks 2023 Treatment Timeline for Medical Study. Trial Name: NCT04007393 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you provide more context on this treatment by sharing other scientific research surrounding it?

"Currently, 20 clinical trials are underway to further research this treatment. Notably, 3 of these trials have reached Phase 3. However, these experiments are being conducted in 36 different locations, with several taking place in Sherbrooke, Quebec."

Answered by AI

Is this medication legally allowed to be prescribed in the USA?

"Although there is some evidence that this treatment may be safe, it only received a score of 2 because this is a Phase 2 trial and no efficacy data has been collected yet."

Answered by AI

What are the primary indicatations for this medication?

"This medication is effective against tonic-clonic seizures and can also be taken to manage lipidemia, lennox gastaut syndrome (lGS), and type 2 diabetes mellitus."

Answered by AI

Are patients being actively sought for this research study?

"According to the latest update on clinicaltrials.gov, this trial is currently looking for participants. This particular study was originally posted on November 21st, 2019 but has undergone recent edits on September 21st, 2020."

Answered by AI

Is this research project only enrolling young people, or are older adults eligible as well?

"This particular clinical trial only enrolls patients that are 12 to 17 years old. Out of the 949 total studies, this is one of 265 trials for people under 18 and 684 trials for those over 65."

Answered by AI

How many participants will this research project be able to include?

"That is correct. The clinical trial detailed on clinicaltrials.gov is recruiting patients. The posting went up on November 21st, 2019 and was last updated September 21st, 2020. They are looking for 150 individuals across 1 site."

Answered by AI

Might I be eligible to join this clinical trial?

"This trial is looking for 150 participants that suffer from pediatric obesity, defined as a BMI of 35 kg/m2 or above. The ideal candidate is aged 12-17 and of Tanner stage 2 or higher. For male candidates of reproductive potential, they must be willing to use condoms or take other measures to ensure contraception with their partner. Lastly, all potential study subjects must be available for the duration of the trial period."

Answered by AI

Who else is applying?

What site did they apply to?
University of Minnesota
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
SMART Use of Medication for the Treatment of Adolescent Severe Obesity
2019. "SMART Use of Medication for the Treatment of Adolescent Severe Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04007393.
~11 spots leftby Aug 2024
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