Status:
ACTIVE_NOT_RECRUITING
Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity
Lead Sponsor:
University of Minnesota
Conditions:
Pediatric Obesity
Eligibility:
All Genders
12-20 years
Phase:
EARLY_PHASE1
Brief Summary
As the prevalence of obesity rises in the U.S., so does the incidence of pediatric type 2 diabetes (T2D), which is associated with more aggressive disease progression than in adults. From 2002-2012, t...
Detailed Description
This is a pilot, pragmatic, randomized trial with a 6-month placebo-controlled period followed by a 6-month open-label extension, investigating the effects of phentermine/topiramate on BMI, insulin se...
Eligibility Criteria
Inclusion
- Ages 12 to \</= 20 years at study entry
- Obesity (BMI \>/= the 95th percentile for age and sex)
- HgbA1c \>/= 6.5% at type 2 diabetes diagnosis
- Negative diabetes auto-antibodies
- English-speaking and Spanish speaking
- For participants of child-bearing potential: when sexually active, agreement to use two forms of highly effective contraception (oral contraceptive pill, IUD, implant, and/or condoms) during study participation
Exclusion
- Pregnancy or lactation
- Newly-initiated or change in dose of weight altering medication within past 6 months, including SGLT-2 inhibitors and DPP-IV inhibitors, liraglutide 1.8 mg and exenatide ER.
- Current or recent (\< six months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination PHN/TPM, semaglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
- Current use of sulfonylureas
- Previous metabolic/bariatric surgery
- Current use of a stimulant medication
- History of glaucoma
- Current or recent (\< 14 days) use of monoamine oxidase inhibitor or carbonic anhydrase inhibitors
- Known hypersensitivity to sympathomimetic amines
- Any history of treatment with growth hormone
- any history of bulimia nervosa
- Major psychiatric disorder as determined by the local medical monitor
- Unstable and clinically-diagnosed (defined as documented in the medical record, if available) depression or PHQ-9 score of \>/= 15
- Any history of active suicide attempt, a "yes" answer to Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) on the "Suicidal Ideation" portion of the C-SSR, or a "yes" to answer to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS
- History of suicidal ideation or self-harm within the previous 30 days or a "yes" answer to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act, or behavior) on the "Suicidal Behavior" portion of the C-SSRS and the ideation or behavior occurred within the past month.
- Current pregnancy or plans to become pregnant during study participation
- Current tobacco use
- ALT or AST \>/= 3 times the upper limit of normal
- Moderate (Child-Pugh score 7-9) or severe (Child-Pugh score 10-15)
- Bicarbonate \<18 mmol/L
- Moderate (creatinine clearance \[CrCl\] greater than or equal to 30 and less than 50 mL/min) or severe (CrCl less than 30 mL/min) renal impairment
- Any history of seizures
- • BP for ages 13 and older of \> 130/80 on 3 separate measurements and for age 12 \> 95th percentile on 3 separate measurements
- HR ≥120 bpm on 3 separate measurements
- History of structural heart defect or clinically significant arrhythmia
- Diagnosed monogenic obesity
- Any history of cholelithiasis
- Any history of nephrolithiasis
- Clinically diagnosed hyperthyroidism
- Untreated thyroid disorder or TSH below the lower laboratory limit of normal
- Any disorder, unwillingness, or inability, not covered by any other exclusion criteria, which in the investigator's opinion may put the participant at risk
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2026
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04881799
Start Date
July 7 2022
End Date
October 27 2026
Last Update
October 31 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55414