Clinical trial NCT03560375: Mediterranean Diet, Circuit Resistance Training, Empagliflozin in Elderly With Type 2 Diabetes: a Study Protocol
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Sarcopenia
Weight Loss
Frailty
Keywords: Weight loss; Diabetes; Frailty; Sarcopenia
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single center, open-label (primary outcome assessors blinded), parallel group, clinical trial of circuit resistance training for 10 weeks; V-Med diet for 10 weeks and then circuit resistance training on top of diet for 10 weeks; empagliflozin 10mg/day for 10 weeks and then circuit resistance training on top of drug therapy for 10 weeks in subjects with type 2 diabetes mellitus
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

Subjects who have type 2 diabetes mellitus in accordance with American Diabetes Association guidelines and:

1. Are ≥65 years of age (inclusive) on the day of signing the informed consent form.
2. Perform \<2 days a week of any leisure aerobic physical activity (PA), who are able to walk independently either with or without an assistance device (cane or walker).
3. HbA1C ≥6.5% to ≤8%.

Exclusion Criteria:

1. Recent use of steroid agents (\<6 months, replacement therapy is allowed)
2. Uncorrected hypothyroidism \[thyroid stimulating hormone (TSH) \> 6 mlU/L\]
3. Diagnosis of malignancy within the past 5 years except for non-melanoma skin cancer.
4. Severe kidney disease (eGFR\<45cc/ml)
5. Active depression
6. Recent (≤6 months) or unstable cardiovascular condition; New York Heart Association (NYHA) Class 3 or higher congestive heart failure;
7. Subjects with PA limiting pain due to neuropathy
8. Subjects who are in an active nutritional therapy changed their diet recently (\<1 month) and/or in a weight-loss program (actively losing weight).
9. Has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results.

Primary outcomes:
measure: Change in body weight
timeFrame: After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)
Secondary outcomes:
measure: Change in fasting plasma glucose
timeFrame: After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)
measure: Change in sarcopenia
timeFrame: After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)
measure: Change in strength
timeFrame: After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)
measure: Relative lean mass change
timeFrame: after 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)
measure: Change in frailty syndrome
timeFrame: After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: The Institute of Endocrinology Metabolism and Hypertension
Study officials:
References:
citation: Kis O, Buch A, Eldor R, Rubin A, Dunsky A, Stern N, Moran DS. Should knee extension strength testing be implemented as a screening test for identifying probable and confirmed sarcopenia in older T2DM patients? Eur Rev Aging Phys Act. 2022 Jan 27;19(1):5. doi: 10.1186/s11556-021-00280-y.
citation: Buch A, Eldor R, Kis O, Keinan-Boker L, Dunsky A, Rubin A, Lopez A, Sofer Y, Osher E, Marcus Y, Stern N. 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 Geriatr. 2019 Aug 22;19(1):228. doi: 10.1186/s12877-019-1219-7.