2068-P: Effect of Phentermine/Topiramate on Insulin Sensitivity and Beta-Cell Function in Adolescents with Youth-Onset Type 2 Diabetes and Obesity

IF 9.3 1区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes Pub Date : 2026-06-11 DOI:10.2337/db26-2068-p

MEGAN O. BENSIGNOR, REBECCA FREESE, AARON S. KELLY, KYLE RUDSER, SILVA ARSLANIAN

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Abstract

Introduction and Objective: First-line treatment for youth-onset type 2 diabetes (Y-T2D) does not improve insulin sensitivity (IS) and β-cell function (BCF). This study aims to evaluate phentermine/topiramate (PHEN/TPM) versus placebo on IS and BCF for adolescents with Y-T2D. Methods: A 24-week trial in adolescents, 12-20 years, with Y-T2D was conducted. Participants were randomized 1:1 to placebo or PHEN/TPM, an oral obesity medication. PHEN/TPM was increased to 15 mg/92 mg after 8 weeks. Participants treated with metformin ± insulin prior to enrollment remained on these medications. A 2 hour, 75-gram OGTT was performed at baseline and 24 weeks with assessment of insulinogenic index (IGI; ΔInsulin30/Δglucose30), IS (1/fasting insulin), and BCF relative to IS (oral deposition index [oDI]). Linear regression estimated the treatment effect on IS and BCF adjusted for baseline values. Results: Thirteen participants (mean age: 15.5 ± 2.07 years, 38.5% female) were randomized. Baseline HbA1c was 8.1% ± 1.7 with 53.8% of participants on insulin therapy. The estimated treatment difference (ETD) in oDI, insulin sensitivity and IGI were not statistically significant (Table 1). Conclusion: PHEN/TPM was not associated with significant changes in IS or BCF in adolescents with T2D compared to placebo. A larger sample size may be needed for significant improvements to surface in IS and BCF consequent to adiposity reductions with PHEN/TPM. Disclosure M.O. Bensignor: Research Support; Current; Dexcom, Inc., Vivus Inc. R. Freese: None. A.S. Kelly: Advisory Panel; Current; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk. Research Support; Current; Vivus, Novo Nordisk. K. Rudser: None. S. Arslanian: None. Funding National Institutes of Health NIDDK K23DK129721

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2068-P：芬特明/托吡酯对青少年2型糖尿病和肥胖症患者胰岛素敏感性和β细胞功能的影响

简介与目的：青年型2型糖尿病（Y-T2D）的一线治疗并没有改善胰岛素敏感性（IS）和β细胞功能（BCF）。本研究旨在评估芬特明/托吡酯（phentmine /topiramate, PHEN/TPM）与安慰剂对Y-T2D青少年IS和BCF的影响。方法：对12-20岁青少年进行为期24周的Y-T2D试验。参与者以1:1的比例随机分配到安慰剂组或口服肥胖药物PHEN/TPM组。8周后PHEN/TPM增加至15 mg/92 mg。在入组前接受二甲双胍±胰岛素治疗的参与者仍在使用这些药物。在基线和24周进行2小时75克OGTT，评估胰岛素生成指数（IGI； ΔInsulin30/Δglucose30）、IS（1/空腹胰岛素）和BCF相对于IS（口腔沉积指数[oDI]）。线性回归估计治疗对IS和BCF的影响，并调整基线值。结果：随机纳入13例，平均年龄15.5±2.07岁，女性38.5%。基线HbA1c为8.1%±1.7,53.8%的参与者接受胰岛素治疗。oDI、胰岛素敏感性和IGI的估计治疗差异（ETD）无统计学意义（表1）。结论：与安慰剂相比，PHEN/TPM与青少年T2D患者IS或BCF的显著变化无关。通过PHEN/TPM减少肥胖，可能需要更大的样本量来显著改善IS和BCF表面。披露方式：研究支持；当前的;Dexcom, Inc., Vivus Inc.弗里斯：没有。A.S. Kelly：咨询小组；当前的;勃林格殷格翰国际有限公司，礼来公司，诺和诺德。研究支持;当前的;Vivus，诺和诺德。K. Rudser：没有。S. Arslanian：没有。资助国家卫生研究院NIDDK K23DK129721

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来源期刊

Diabetes 医学-内分泌学与代谢

CiteScore

12.50

自引率

2.60%

发文量

1968

审稿时长

1 months

期刊介绍： Diabetes is a scientific journal that publishes original research exploring the physiological and pathophysiological aspects of diabetes mellitus. We encourage submissions of manuscripts pertaining to laboratory, animal, or human research, covering a wide range of topics. Our primary focus is on investigative reports investigating various aspects such as the development and progression of diabetes, along with its associated complications. We also welcome studies delving into normal and pathological pancreatic islet function and intermediary metabolism, as well as exploring the mechanisms of drug and hormone action from a pharmacological perspective. Additionally, we encourage submissions that delve into the biochemical and molecular aspects of both normal and abnormal biological processes. However, it is important to note that we do not publish studies relating to diabetes education or the application of accepted therapeutic and diagnostic approaches to patients with diabetes mellitus. Our aim is to provide a platform for research that contributes to advancing our understanding of the underlying mechanisms and processes of diabetes.