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

PHASE4CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 9, 2018

Primary Completion Date

February 10, 2021

Study Completion Date

February 10, 2021

Conditions
Diabetes Mellitus, Type 2SarcopeniaWeight Loss
Interventions
BEHAVIORAL

Circuit resistance training (CRT)

"Subjects will be allocated to CRT which consists of 10 resistance exercises for different body parts (=1 circuit) repeated 12-15 times, using modest weights (approximately 40-60% of one repetition maximum, RM). Each exercise is expected to be completed within 30-40 sec. The participant will move quickly (within 15-30 seconds) from one exercise to the next. The circuit will be repeated up to three times depending on the week of intervention. Thus, it will take about 30 min to complete an exercise session. For a summary of articles on CRT in older adults based on a meta-analysis, we performed please see:~Circuit resistance training is an effective means to enhance muscle strength in older and middle-aged adults: A systematic review and meta-analysis. Ageing Res Rev. 2017 Aug;37:16-27"

BEHAVIORAL

Vegeterranean diet (V-Med diet)

The modified V-Med diet will be considered as ad-libitum (using fat sources) aimed for a minimum of 1 gr/kg/day of protein, limiting carbohydrates: 3 servings for men and 2 servings for women per main meal and 1 serving per intermediate meal for both genders. Subjects will be asked to avoid red meat and poultry completely and the consumption of dairy and eggs products will be limited to 2 servings per day. 2-3 servings of fish should be consumed during the week. The rest of protein consumption will be recommended from legumes sources. The target legume consumption will be 1.5 cup per day (2 servings per day) of cooked beans, chickpeas, lentils and/or using pulses-based flour or pulses-based bread. Consumption of whole grain carbohydrate foods will be recommended.

DRUG

Empagliflozin 10 MG

Subjects allocated to empagliflozin will be asked to add empagliflozin 10mg, preferably in the morning, to their medication regimen. Subjects will be monitored for adverse events including hypoglycemic events during all study visits.

Trial Locations (1)

64239

The Institute of Endocrinology Metabolism and Hypertension, Tel Aviv

All Listed Sponsors
lead

Tel-Aviv Sourasky Medical Center

OTHER_GOV

NCT03560375 - Mediterranean Diet, Circuit Resistance Training, Empagliflozin in Elderly With Type 2 Diabetes: a Study Protocol | Biotech Hunter | Biotech Hunter