Mediterranean Diet, Circuit Resistance Training, Empagliflozin in Elderly With Type 2 Diabetes: a Study Protocol

Tel Aviv Sourasky Medical Center

Status and phase: Completed; Phase 4

Conditions: Weight Loss; Diabetes Mellitus, Type 2; Sarcopenia

Treatments: Drug: Empagliflozin 10 MG; Behavioral: Circuit resistance training (CRT); Behavioral: Vegeterranean diet (V-Med diet)

Study type: Interventional

Funder types: Other

Identifiers

NCT03560375

TLV-0816-17

Details and patient eligibility

About

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 metabolic 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 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, fat mass %, sarcopenia measures (such as strength and physical function), HbA1c and blood pressure as well as other outcomes (both objective and subjective). Safety will be evaluated by routine monitoring of adverse events. This study was approved by the Tel-Aviv Sourasky Medical Center Institutional Review Board

Enrollment: 100 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 3 patient groups

Circuit resistance training (CRT)

Experimental group

Description:

2-3 circuits \* 10 exercises \* 3 times per week

Treatment:

Behavioral: Circuit resistance training (CRT)

Empagliflozin 10 MG

Experimental group

Description:

10 mg once daily

Treatment:

Drug: Empagliflozin 10 MG

Vegeterranean diet (V-Med diet)

Experimental group

Description:

The modified V-Med diet will be considered as ad-libitum (using fat sources), aimed for sufficient protein from animal and mainly plant-based sources with carbohydrates limitation.

Treatment:

Behavioral: Vegeterranean diet (V-Med diet)