Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel.
Tel Aviv Sourasky Medical Center, The Sagol Center for Epigenetics of Aging and Metabolism, the Institute of Endocrinology, Metabolism and Hypertension, Tel-Aviv, Israel.
BMC Geriatr. 2019 Aug 22;19(1):228. doi: 10.1186/s12877-019-1219-7.
Treatment of the older diabetic individual comprises a therapeutic challenge. Currently little scientific evidence exists depicting the best approach to type 2 diabetes treatment in this growing sub-population of patients. The purpose of this study is to assess the effects of a modified plant-based Mediterranean diet ("vegeterranean" diet), circuit resistance training (CRT) and empagliflozin, separately or in combination, on body composition and physical function in older subjects with type 2 diabetes. The rationale for this study is to assess three interventions associated with a negative energy/caloric balance (increased caloric use in exercise, caloric restriction in the "vegeterranean" diet and caloric wasting by glycosuria with empagliflozin), their interaction and effect on body composition and physical function.
One hundred and twenty men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity will be randomized (1:1:1 manner, gender stratified) for 10 weeks to one of 3 parallel arms: CRT consisting of 3 home sessions/week; ad-libitum plant-based Mediterranean diet (limited consumption of eggs, dairy and fish, avoidance of red meat and poultry) or empagliflozin 10 mg/day. After 10 weeks CRT will be added to the empagliflozin and diet arms for an additional 10 weeks. Allocation concealment and blinding of primary outcome assessors will be implemented. Efficacy will be determined by assessment of lean body mass, body weight, frailty and functional status, sarcopenia, HbA1c and quality of life questionnaires. Safety will be evaluated by routine monitoring of adverse events. This study was approved by the Tel-Aviv Sourasky Medical Center Institutional Review Board.
The combination and comparison of these diverse interventions to metabolic control may lead to better understanding of their mechanism of action with potential clinical implications in older individuals. Also, this study will provide evidence of the effectiveness of these interventions on delaying the progression from diabetes to sarcopenia and/or frailty.
ClinicalTrials.gov PRS: NCT03560375 . Last registration date (last update): 06/06/2018. The trial was a-priori registered before actual recruitment of subjects.
治疗老年糖尿病患者是一个具有挑战性的治疗课题。目前，关于如何治疗这一不断增长的老年糖尿病患者亚群，科学证据有限。本研究的目的是评估改良植物性地中海饮食（“vegeterranean”饮食）、循环阻力训练（CRT）和恩格列净单独或联合使用对 2 型糖尿病老年患者的身体成分和身体功能的影响。本研究的基本原理是评估三种干预措施，这些措施都与负能/热量平衡有关（运动中增加热量消耗、“vegeterranean”饮食中热量限制和恩格列净引起的糖利尿性热量损失），评估它们的相互作用以及对身体成分和身体功能的影响。
将 120 名年龄在 65 岁以上、身体活动水平低、患有 2 型糖尿病的男性和女性随机分为三组（1:1:1 比例，按性别分层），每组进行 10 周的平行治疗：每周进行 3 次家庭 CRT；自由摄入植物性地中海饮食（限制鸡蛋、奶制品和鱼类的摄入，避免食用红肉和家禽）或恩格列净 10mg/天。10 周后，CRT 将被添加到恩格列净和饮食组中，再进行 10 周。将实施随机分配隐藏和主要结局评估人员的盲法。通过评估瘦体重、体重、虚弱和功能状态、肌肉减少症、HbA1c 和生活质量问卷来确定疗效。通过常规监测不良事件来评估安全性。本研究已获得特拉维夫索拉斯基医疗中心机构审查委员会的批准。
将这些不同的干预措施与代谢控制相结合并进行比较，可能会更好地了解它们的作用机制，这可能对老年患者具有潜在的临床意义。此外，本研究将提供这些干预措施对延缓糖尿病向肌肉减少症和/或虚弱发展的有效性证据。
ClinicalTrials.gov PRS：NCT03560375。最后注册日期（最后更新）：2018 年 6 月 6 日。该试验在实际招募受试者之前已预先注册。
