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Diabetes Mellitus, Type 2Phase 4NCT03560375

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

A Phase 4 study testing Circuit resistance training (CRT), Vegeterranean diet (V-Med diet) and Empagliflozin 10 MG in people with Diabetes Mellitus, Type 2 and Sarcopenia, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 metabolic and physical function in elderly subjects with type 2 diabetes. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Diabetes Mellitus, Type 2, Sarcopenia, Weight Loss
What is being tested?
Circuit resistance training (CRT), Vegeterranean diet (V-Med diet) and Empagliflozin 10 MG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteIsrael
Study dates
9 May 2018to 10 Feb 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Subjects who have type 2 diabetes mellitus in accordance with American Diabetes Association guidelines and:
  • Are ≥65 years of age (inclusive) on the day of signing the informed consent form.
  • 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).
  • HbA1C ≥6.5% to ≤8%.

Who cannot join

  • Recent use of steroid agents (<6 months, replacement therapy is allowed)
  • Uncorrected hypothyroidism [thyroid stimulating hormone (TSH) > 6 mlU/L]
  • Diagnosis of malignancy within the past 5 years except for non-melanoma skin cancer.
  • Severe kidney disease (eGFR<45cc/ml)
  • Active depression
  • Recent (≤6 months) or unstable cardiovascular condition; New York Heart Association (NYHA) Class 3 or higher congestive heart failure;
Show all 9Show fewer
  • Subjects with PA limiting pain due to neuropathy
  • Subjects who are in an active nutritional therapy changed their diet recently (<1 month) and/or in a weight-loss program (actively losing weight).
  • 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 locations and contacts

1 site in 1 country.

Israel1 site

  • The Institute of Endocrinology Metabolism and Hypertension

    Tel Aviv, 64239

Other trials in Israel

About this study

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 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

Being tested
Circuit resistance training (CRT), Vegeterranean diet (V-Med diet), Empagliflozin 10 MG
Keywords
Type 2 diabetes, Sarcopenia, Weight loss, Physical function, Metabolic control, Older adults
Medical subject headings
Diabetes Mellitus, Type 2, Sarcopenia, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Circuit resistance training (CRT)Behavioural

    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

  • Vegeterranean diet (V-Med diet)Behavioural

    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.

  • Empagliflozin 10 MGDrug

    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.

Study groups in NCT03560375
Study groupRoleWhat they receive
Circuit resistance training (CRT)Experimental2-3 circuits * 10 exercises * 3 times per week
Receives: Behavioral: Circuit resistance training (CRT)
Empagliflozin 10 MGExperimental10 mg once daily
Receives: Drug: Empagliflozin 10 MG
Vegeterranean diet (V-Med diet)ExperimentalThe 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.
Receives: Behavioral: Vegeterranean diet (V-Med diet)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A composite of metabolic and functional indices

    In the 'metabolic index' 1 point was given for achieving a reduction of at least 2% in body fat, 2cm of waist circumference, 0.5% HbA1c and 5mmHg systolic blood pressure (final score 0-4). Metabolic threshold values that reflect the desired reduction were chosen based preferably on meta-analyses of randomized trials (or single RCT) that examined the impact of weight loss/lifestyle interventions (diet and/or physical exercise - focus on interventions as similar to our interventions) and pharmacotherapy (e.g., empagliflozin) in populations of overweight and obese (with/without diabetes) adults/ older adults. We reviewed the threshold values and set the final values taking into account the data reviewed for each metabolic variable.The 'functional index' awarded one point for preservation or increase in total skeletal muscle mass, HGS, isometric knee extension, and TUG results (final score 0-4).

    Measured: After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)

Secondary outcomes (4)

  1. Change in fasting plasma glucose

    Change in fasting plasma glucose (%) will be calculated as fasting plasma glucose (mg/dl) at the end of 10 weeks (and 20 weeks) minus baseline fasting plasma glucose divided by fasting plasma glucose at baseline and multiplied by 100.

    Measured: After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)

  2. Change in sarcopenia

    Sarcopenia will be assessed by results obtained in the In-Body (720) body composition analyzer, following the consensus definitions offered elsewhere (Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, et al. Sarcopenia: European consensus on definition and diagnosis. Age Ageing. 2010 Jul;39(4):412-23.). Shortly, the skeletal muscle index (SMI = skeletal muscle mass/body mass x 100) will be compared to gender-specific reference norms of young adults (aged 18-39 years). Sarcopenia will be defined as any value < 10.76 kg/m2 for men and < 6.76 kg/m2 for women. Sarcopenia change will be considered as "improved vs. not improved"; change from one level to the other

    Measured: After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)

  3. Change in strength

    Grip strength, assessed as the average of 3 readings of the dominant hand by a handheld dynamometer [Jamar® Plus+ Digital Hand Dynamometer (Jamar® Smart) 200-lb.]. Change in grip strength (%) will be calculated as grip strength at the end of 10 weeks (and 20 weeks) minus baseline grip strength divided by grip strength at baseline and multiplied by 100.

    Measured: After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)

  4. Relative lean mass change

    Relative lean mass change will be calculated as % lean mass (the proportion of lean mass out of weight) at the end of study minus % lean mass at baseline divided by lean mass % at baseline and multiplied by 100

    Measured: after 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2018
  2. Study start9 May 2018
  3. Primary completion10 Feb 2021
  4. Study completion10 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03560375
Sponsor's protocol ID
TLV-0816-17
Status last verified
Jun 2018
First submitted
6 May 2018
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gonen LD, Buch A, Eldor R, Yaish I, Barak S. Clinical similarity, economic divergence: cost-effectiveness and population health implications of dietary, pharmacological, and exercise interventions in older adults with type 2 diabetes: a secondary analysis of a randomized controlled trial. BMC Geriatr. 2026 Jul 25;26(1):1321. doi: 10.1186/s12877-026-07994-7.

    PubMed 42902215

  • Barak S, Eldor R, Dotan I, Brown R, Izkhakov E, Greenman Y, Prado CM, Buch A. Variability in muscle function deficits and clinical identification of sarcopenic obesity in older adults with type 2 diabetes. Front Med (Lausanne). 2026 Feb 18;12:1747916. doi: 10.3389/fmed.2025.1747916. eCollection 2025.

    PubMed 41789181

  • 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.

    PubMed 35086483

  • 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.

    PubMed 31438863

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Circuit resistance training (CRT), Vegeterranean diet (V-Med diet) and Empagliflozin 10 MG in people with Diabetes Mellitus, Type 2 and Sarcopenia, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A composite of metabolic and functional indices (time frame: After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03560375, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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