Division of Endocrinology, Department of Medicine, University of Texas Health Science Center San Antonio, San Antonio, TX, United States.
Sam & Ann Barshop Institute for Longevity & Aging Studies, University of Texas Health Science Center San Antonio, San Antonio, TX, United States.
JMIR Res Protoc. 2024 Sep 13;13:e62667. doi: 10.2196/62667.
Older adults with type 2 diabetes mellitus (T2DM) or prediabetes are at increased risk of adverse changes in body composition, physical function, and aging-related biomarkers compared to those with normal glucose tolerance. Semaglutide is a glucagon-like peptide 1 receptor agonist that has been approved for T2DM and chronic weight management. Although semaglutide is effective for weight loss and T2DM management, its effects on lean body mass, physical function, and biomarkers of aging are understudied in older adults.
This study aims to compare the effects of lifestyle counseling with and that without semaglutide on body composition, physical function, and biomarkers of aging in older adults.
This is an open-label randomized controlled trial. A total of 20 adults (aged 65 years and older) with elevated BMI (27-40 kg/m) and prediabetes or well-controlled T2DM (hemoglobin A 5.7%-7.5%) are recruited, stratified by sex, and randomized 1:1 to one of 2 groups (semaglutide plus lifestyle counseling vs lifestyle counseling alone) and followed up for 5 months. Those in the semaglutide group are titrated to 1 mg weekly, as tolerated, for 12 weeks. Lifestyle counseling is given by registered dietitians and based on the Diabetes Prevention Program Lifestyle Change Program. Our primary outcomes include changes in lean mass, physical function, and biomarkers of aging. Body composition is measured by dual-energy x-ray absorptiometry and includes total fat mass and lean mass. Physical function is measured by 6-minute walk distance, grip strength, and short physical performance battery. Biomarkers of aging are measured in blood, skeletal muscle, and abdominal adipose tissue to include C-reactive protein, interleukin-6, tumor necrosis factors α, and β galactosidase staining.
The study was funded in December 2021 with a projected data collection period from spring 2023 through summer 2024.
Despite the elevated risk of adverse changes in body composition, physical function, and biomarkers of aging among older adults with glucose intolerance and elevated adiposity, the benefits and risks of commonly prescribed antihyperglycemic or weight loss medications such as semaglutide are understudied. This study aims to fill this knowledge gap to inform clinicians about the potential for additional clinically meaningful, nonglycemic effects of semaglutide.
ClinicalTrials.gov NCT05786521; https://clinicaltrials.gov/study/NCT05786521.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/62667.
与血糖正常的成年人相比，患有 2 型糖尿病（T2DM）或糖尿病前期的老年人更容易出现身体成分、身体功能和与衰老相关的生物标志物的不良变化。司美格鲁肽是一种胰高血糖素样肽 1 受体激动剂，已被批准用于治疗 T2DM 和慢性体重管理。尽管司美格鲁肽可有效减轻体重和治疗 T2DM，但它对老年人瘦体重、身体功能和衰老生物标志物的影响仍研究不足。
本研究旨在比较生活方式咨询联合和不联合司美格鲁肽对老年人身体成分、身体功能和衰老生物标志物的影响。
这是一项开放标签的随机对照试验。共招募了 20 名年龄在 65 岁及以上、BMI（27-40kg/m）升高且患有糖尿病前期或血糖控制良好的 T2DM（糖化血红蛋白 5.7%-7.5%）的成年人，按性别分层后，按 1:1 随机分为两组（司美格鲁肽联合生活方式咨询组和生活方式咨询组），并随访 5 个月。司美格鲁肽组患者可耐受时，每周递增至 1mg，持续 12 周。生活方式咨询由注册营养师提供，基于糖尿病预防计划生活方式改变计划。我们的主要结局包括瘦体重、身体功能和衰老生物标志物的变化。通过双能 X 射线吸收法测量身体成分，包括总脂肪量和瘦体重。身体功能通过 6 分钟步行距离、握力和简短体能测试来测量。衰老生物标志物通过血液、骨骼肌和腹部脂肪组织测量，包括 C 反应蛋白、白细胞介素 6、肿瘤坏死因子 α 和β-半乳糖苷酶染色。
该研究于 2021 年 12 月获得资金，预计数据收集期为 2023 年春季至 2024 年夏季。
尽管血糖不耐受和肥胖的老年人身体成分、身体功能和衰老生物标志物不良变化的风险较高，但普遍开具的抗高血糖或减肥药物（如司美格鲁肽）的益处和风险仍研究不足。本研究旨在填补这一知识空白，为临床医生提供关于司美格鲁肽可能具有额外临床意义的非血糖作用的信息。
ClinicalTrials.gov NCT05786521；https://clinicaltrials.gov/study/NCT05786521。
国际注册报告标识符（IRRID）：DERR1-10.2196/62667。
