Diabetes Mellitus, Type 2 Clinical Trial
Official title:
The Effect of a Circuit Resistance Training, Empagliflozin or "Vegeterranean Diet" on Physical and Metabolic Function in Elderly Subjects With Type 2 Diabetes: a Study Protocol for a Randomized Control Trial (CEV-65 Trial)
Primary objective: To assess the effects of a modified plant-based Mediterranean diet
(vegeterranean diet), circuit resistance training (CRT) and empagliflozin alone or in
combination on body composition and physical function in elderly 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 and analysis: 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 10mg/day. After 10 weeks CRT
will be added to the empagliflozin or 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 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
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