The effect of circuit resistance training, empagliflozin or “vegeterranean diet” on physical and metabolic function in older subjects with type 2 diabetes: a study protocol for a randomized control trial (CEV-65 trial)

BMC Geriatrics

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[1] 0000 0001 0083 3078, grid.433836.9, The Academic College at Wingate, Wingate Institute, Netanya, Israel;0000 0001 0518 6922, grid.413449.f, Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel;0000 0000 9824 6981, grid.411434.7, The Faculty of Health Sciences, Ariel University, Ariel, Israel;0000 0001 0518 6922, grid.413449.f, Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel;0000 0001 0518 6922, grid.413449.f, Tel Aviv Sourasky Medical Center, The Sagol Center for Epigenetics of Aging and Metabolism, the Institute of Endocrinology, Metabolism and Hypertension, Tel-Aviv, Israel;0000 0004 1937 0546, grid.12136.37, The Sackler Faculty of Medicine Tel-Aviv University, Tel-Aviv, Israel;0000 0001 0518 6922, grid.413449.f, Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel;0000 0004 1937 0546, grid.12136.37, The Sackler Faculty of Medicine Tel-Aviv University, Tel-Aviv, Israel;0000 0004 1937 0562, grid.18098.38, School of Public Health, University of Haifa, Haifa, Israel;0000 0004 1937 0562, grid.18098.38, School of Public Health, University of Haifa, Haifa, Israel;0000 0004 1937 052X, grid.414840.d, Israel Center for Disease Control, Israel Ministry of Health, Ramat Gan, Israel;

关键词: Weight loss;    Diabetes;    Frailty;    Muscle function;    Muscle mass;    Sarcopenia;   

DOI  :  10.1186/s12877-019-1219-7

来源: publisher

【 摘 要 】

BackgroundTreatment 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.MethodsOne 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.DiscussionThe 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.Trial registrationClinicalTrials.gov PRS: NCT03560375. Last registration date (last update): 06/06/2018. The trial was a-priori registered before actual recruitment of subjects.

【 授权许可】

CC BY