Panacea Index Logo

Command Palette

Search for a command to run...

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
January 1, 1970
Assaf Buch et al. (11 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

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.

Extracted Claims (30)
InterventionDirectionEndpointPopulationDosageImpactClaim #
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
Abstract

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.

Medical Subject Headings (MeSH)
AgedAged, 80 and overBenzhydryl CompoundsBody CompositionBody WeightCaloric RestrictionCombined Modality TherapyDiabetes Mellitus, Type 2Diet, MediterraneanDiet, VegetarianExerciseFemaleGlucosidesHumansMaleResistance TrainingSodium-Glucose Transporter 2 InhibitorsSurveys and QuestionnairesTreatment Outcome
Study Links
Quality Scores
SafetyNot Assessed
Quality85/10
Citation Metrics
Total Citations15
Citations/Year2.5
Relative Citation Ratio0.99
NIH Percentile49.7%
Research Impact Scores
APT Score0.75
Weight Score1.77
Normalized Score0.57
Related Supplements