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).
Study Goal
The researchers aimed to assess the effects of a modified plant-based Mediterranean diet (with limited dairy consumption) combined with exercise and medication on body composition and physical function in older individuals with type 2 diabetes.
Results Summary
The abstract does not provide specific results regarding dairy's effects, as the focus was on the combined impact of diet, exercise, and medication.
Population
Older men and women (≥65 years) with type 2 diabetes and low physical activity levels.
Effective Dosage
Not specified for dairy (diet involved limited consumption).
Duration
20 weeks (10 weeks for initial intervention, followed by an additional 10 weeks with added CRT).
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
modified plant-based Mediterranean diet ("vegeterranean" diet) | neutral | body composition and physical function | older subjects with type 2 diabetes | - | assess the effects | #1 |
circuit resistance training (CRT) | neutral | body composition and physical function | older subjects with type 2 diabetes | - | assess the effects | #2 |
empagliflozin | neutral | body composition and physical function | older subjects with type 2 diabetes | - | assess the effects | #3 |
modified plant-based Mediterranean diet ("vegeterranean" diet), circuit resistance training (CRT) and empagliflozin, separately or in combination | neutral | body composition and physical function | older subjects with type 2 diabetes | - | assess the effects | #4 |
circuit resistance training (CRT) | increase | caloric use | - | - | associated with a negative energy/caloric balance | #5 |
modified plant-based Mediterranean diet ("vegeterranean" diet) | neutral | caloric restriction | - | - | associated with a negative energy/caloric balance | #6 |
empagliflozin | neutral | caloric wasting by glycosuria | - | - | associated with a negative energy/caloric balance | #7 |
circuit resistance training (CRT) | neutral | body composition and physical function | - | - | effect | #8 |
modified plant-based Mediterranean diet ("vegeterranean" diet) | neutral | body composition and physical function | - | - | effect | #9 |
empagliflozin | neutral | body composition and physical function | - | - | effect | #10 |
circuit resistance training (CRT) | neutral | lean body mass | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #11 |
circuit resistance training (CRT) | neutral | body weight | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #12 |
circuit resistance training (CRT) | neutral | frailty and functional status | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #13 |
circuit resistance training (CRT) | neutral | sarcopenia | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #14 |
circuit resistance training (CRT) | neutral | HbA1c | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #15 |
circuit resistance training (CRT) | neutral | quality of life | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #16 |
modified plant-based Mediterranean diet ("vegeterranean" diet) | neutral | lean body mass | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #17 |
modified plant-based Mediterranean diet ("vegeterranean" diet) | neutral | body weight | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #18 |
modified plant-based Mediterranean diet ("vegeterranean" diet) | neutral | frailty and functional status | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #19 |
modified plant-based Mediterranean diet ("vegeterranean" diet) | neutral | sarcopenia | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #20 |
modified plant-based Mediterranean diet ("vegeterranean" diet) | neutral | HbA1c | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #21 |
modified plant-based Mediterranean diet ("vegeterranean" diet) | neutral | quality of life | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #22 |
empagliflozin | neutral | lean body mass | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #23 |
empagliflozin | neutral | body weight | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #24 |
empagliflozin | neutral | frailty and functional status | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #25 |
empagliflozin | neutral | sarcopenia | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #26 |
empagliflozin | neutral | HbA1c | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #27 |
empagliflozin | neutral | quality of life | men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity | - | efficacy will be determined by assessment | #28 |
modified plant-based Mediterranean diet ("vegeterranean" diet), circuit resistance training (CRT) and empagliflozin | neutral | metabolic control | older individuals | - | combination and comparison may lead to better understanding | #29 |
modified plant-based Mediterranean diet ("vegeterranean" diet), circuit resistance training (CRT) and empagliflozin | neutral | delaying the progression from diabetes to sarcopenia and/or frailty | - | - | will provide evidence of the effectiveness | #30 |
BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov PRS: NCT03560375 . Last registration date (last update): 06/06/2018. The trial was a-priori registered before actual recruitment of subjects.