NCT04881799Fut, nem toborozKorai 1. fázis
Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 22.
Rövid összefoglaló (regiszter, angolul)
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, the incidence of T2D in youth increased by 7% annually in the U.S. Compared to adults. T2D in adolescents is a much more progressive and recalcitrant disease, characterized by more rapid deterioration of β-cell function and earlier incidence of exogenous insulin dependence and diabetes-related comorbidities. A potential factor that drives the rapid progression of adolescent T2D is obesity (body mass index [BMI] >95th percentile. Effective and safe treatments targeting both obesity and β-cell dysfunction are needed for pediatric T2D. In 2012, the FDA approved the use of Phentermine/Topiramate for the treatment of obesity in adults. This orally-administered medication is available in mid- (phentermine 7.5 mg; topiramate 46 mg) and high- (phentermine 15 mg; topiramate 92 mg) doses, administered once per day. In a meta-analysis, phentermine/topiramate was shown to be one of the most effective obesity medication currently available. A large dose-ranging trial in adults evaluating phentermine and topiramate as monotherapies vs. phentermine/topiramate demonstrated superior efficacy of the combination with an acceptable safety profile. Results from a large phase III clinical trial demonstrated placebo-subtracted weight loss of >9% with treatment for one year at the top dose. Importantly, a separate trial demonstrated that the treatment effect is durable out to at least two years.41 The most common side effects in these trials were paresthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth. Improvements were noted in blood pressure, lipids, glucose, insulin, HOMA-IR, C-reactive protein, and adiponectin.
- Állapot (regiszter)
- Fut, nem toboroz
- Fázis (regiszter)
- Korai 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 13 (tényleges)
- Első benyújtás
- 2021. máj. 5.
- Kezdés
- 2022. júl. 7.
- Elsődleges befejezés
- 2025. okt. 27.
- Fő szponzor
- University of Minnesota
- Betegségek
- Elhízás, 2-es típusú cukorbetegség
- NCT-szám
- NCT04881799
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · Korai 1. fázis
- Bevont résztvevők: 13
- 2022. júl. 7. és az elsődleges befejezés (2025. okt. 27.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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)
- Previous metabolic/bariatric surgery
- Current use of a stimulant medication
- Current or recent (< 14 days) use of monoamine oxidase inhibitor or carbonic anhydrase inhibitors
- Any history of treatment with growth hormone
- 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.
Más betegség
- History of glaucoma
- Known hypersensitivity to sympathomimetic amines
- any history of bulimia nervosa
- Major psychiatric disorder as determined by the local medical monitor
- 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 structural heart defect or clinically significant arrhythmia
- Any history of cholelithiasis
- Any history of nephrolithiasis
- Any disorder, unwillingness, or inability, not covered by any other exclusion criteria, which in the investigator's opinion may put the participant at risk
Laborértékek
- ALT or AST >/= 3 times the upper limit of normal
- 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
- Untreated thyroid disorder or TSH below the lower laboratory limit of normal
Életkor
- 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
Egyéb
- Pregnancy or lactation
- Current use of sulfonylureas
- Unstable and clinically-diagnosed (defined as documented in the medical record, if available) depression or PHQ-9 score of >/= 15
- Current pregnancy or plans to become pregnant during study participation
- Current tobacco use
- Moderate (Child-Pugh score 7-9) or severe (Child-Pugh score 10-15)
- HR ≥120 bpm on 3 separate measurements
- Diagnosed monogenic obesity
- Clinically diagnosed hyperthyroidism
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 12 év – 20 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Minnesota | Minneapolis | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.