دورية أكاديمية

Effect of Verapamil on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial

التفاصيل البيبلوغرافية
العنوان: Effect of Verapamil on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial
المؤلفون: Forlenza, Gregory P., McVean, Jennifer, Beck, Roy W., Bauza, Colleen, Bailey, Ryan, Buckingham, Bruce, DiMeglio, Linda A., Sherr, Jennifer L., Clements, Mark, Neyman, Anna, Evans-Molina, Carmella, Sims, Emily K., Messer, Laurel H., Ekhlaspour, Laya, McDonough, Ryan, Van Name, Michelle, Rojas, Diana, Beasley, Shannon, DuBose, Stephanie, Kollman, Craig, Moran, Antoinette, CLVer Study Group
المساهمون: Pediatrics, School of Medicine
المصدر: PMC
بيانات النشر: American Medical Association
سنة النشر: 2023
المجموعة: Indiana University - Purdue University Indianapolis: IUPUI Scholar Works
مصطلحات موضوعية: C-peptide, Type 1 diabetes mellitus, Hypoglycemic agents, Insulin-secreting cells, Verapamil
الوصف: Importance: In preclinical studies, thioredoxin-interacting protein overexpression induces pancreatic beta cell apoptosis and is involved in glucotoxicity-induced beta cell death. Calcium channel blockers reduce these effects and may be beneficial to beta cell preservation in type 1 diabetes. Objective: To determine the effect of verapamil on pancreatic beta cell function in children and adolescents with newly diagnosed type 1 diabetes. Design, setting, and participants: This double-blind, randomized clinical trial including children and adolescents aged 7 to 17 years with newly diagnosed type 1 diabetes who weighed 30 kg or greater was conducted at 6 centers in the US (randomized participants between July 20, 2020, and October 13, 2021) and follow-up was completed on September 15, 2022. Interventions: Participants were randomly assigned 1:1 to once-daily oral verapamil (n = 47) or placebo (n = 41) as part of a factorial design in which participants also were assigned to receive either intensive diabetes management or standard diabetes care. Main outcomes and measures: The primary outcome was area under the curve values for C-peptide level (a measure of pancreatic beta cell function) stimulated by a mixed-meal tolerance test at 52 weeks from diagnosis of type 1 diabetes. Results: Among 88 participants (mean age, 12.7 [SD, 2.4] years; 36 were female [41%]; and the mean time from diagnosis to randomization was 24 [SD, 4] days), 83 (94%) completed the trial. In the verapamil group, the mean C-peptide area under the curve was 0.66 pmol/mL at baseline and 0.65 pmol/mL at 52 weeks compared with 0.60 pmol/mL at baseline and 0.44 pmol/mL at 52 weeks in the placebo group (adjusted between-group difference, 0.14 pmol/mL [95% CI, 0.01 to 0.27 pmol/mL]; P = .04). This equates to a 30% higher C-peptide level at 52 weeks with verapamil. The percentage of participants with a 52-week peak C-peptide level of 0.2 pmol/mL or greater was 95% (41 of 43 participants) in the verapamil group vs 71% (27 of 38 participants) in the ...
نوع الوثيقة: article in journal/newspaper
وصف الملف: application/pdf
اللغة: English
العلاقة: Journal of the American Medical Association (JAMA); Forlenza GP, McVean J, Beck RW, et al. Effect of Verapamil on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2023;329(12):990-999. doi:10.1001/jama.2023.2064; https://hdl.handle.net/1805/38992Test
الإتاحة: https://doi.org/10.1001/jama.2023.2064Test
https://hdl.handle.net/1805/38992Test
حقوق: Publisher Policy
رقم الانضمام: edsbas.B819A5DF
قاعدة البيانات: BASE