The effect of circuit resistance training, empagliflozin or \u201cvegeterranean diet\u201d on physical and metabolic function in older subjects with type 2 diabetes: a study protocol for a randomized control trial (CEV-65 trial)

Assaf Buch,Ofer Kis,Etty Osher,Naftali Stern,Amir Rubin,Roy Eldor,Adar Lopez,Lital Keinan-Boker,Ayelet Dunsky,Yael Sofer,Yonit Marcus

doi:10.1186/s12877-019-1219-7

Abstract

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.

Highlights

Treatment of the older diabetic individual comprises a therapeutic challenge
Our study aims to evaluate the effectiveness of three different interventions (V-Med diet, circuit resistance training (CRT) and empagliflozin, separately or in combination) on metabolic, anthropometric and physical function parameters in older subjects with Type 2 Diabetes Mellitus (T2DM)
Several new facets of T2DM treatment in this age group are at the core of this study: 1. This is the first comparison of empagliflozin to lifestyle modification in older patients; 2

Summary

Introduction

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. In the past the older population was characterized by low body weight and malnutrition in contrast to the present in which rates of obesity, metabolic syndrome and T2DM are increasing [3, 4]. One morbidity associated with diabetes in the older population is sarcopenia [9] – a phenomenon of age-related loss of skeletal muscle mass, strength and function. The decreased muscle mass is associated with loss of strength, increased likelihood of falls, and loss of autonomy [10]

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