{"type":"trials","record":{"id":277,"source_id":"clinicaltrials-gov","external_id":"NCT03560375","title":"Mediterranean Diet, Circuit Resistance Training, Empagliflozin in Elderly With Type 2 Diabetes: a Study Protocol","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 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","overall_status":"Completed","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"Tel-Aviv Sourasky Medical Center","enrollment":100,"countries":["Israel"],"start_date":"2018-05-09","completion_date":"2021-02-10","last_update_date":"2025-09-04","source_url":"https://clinicaltrials.gov/study/NCT03560375","editorial_summary":"A registered PHASE4 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-14T02:45:01.944738+00:00","last_seen_at":"2026-09-25T06:25:45.678+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years","comparator":null,"organization":"Tel-Aviv Sourasky Medical Center","interventions":["Circuit resistance training (CRT)","Vegeterranean diet (V-Med diet)","Empagliflozin 10 MG"],"registry_source":"ClinicalTrials.gov","outcome_measures":["A composite of metabolic and functional indices — After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug…","Change in fasting plasma glucose — After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)","Change in sarcopenia — After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)","Change in strength — After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)","Relative lean mass change — after 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Diabetes Mellitus, Type 2","Sarcopenia","Weight Loss","Circuit resistance training (CRT)","Vegeterranean diet (V-Med diet)","Empagliflozin 10 MG"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: mediterranean diet.","quality_checked_at":"2026-09-25T06:25:48.368501+00:00","duplicate_cluster_key":"id:nct03560375","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2018-05-09 to 2021-02-10","comparator":null,"confidence":"structured-source","population":"ALL · 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:25:45.706Z","intervention":["Circuit resistance training (CRT)","Vegeterranean diet (V-Med diet)","Empagliflozin 10 MG"],"participants":100,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE4","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["A composite of metabolic and functional indices — After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug…","Change in fasting plasma glucose — After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)","Change in sarcopenia — After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)","Change in strength — After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)","Relative lean mass change — after 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"mediterranean-diet","is_published":true,"match_reasons":["Title contains controlled term: mediterranean diet.","Abstract contains controlled term: mediterranean diet.","Title supplies longevity context: elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Mediterranean diet","slug":"mediterranean-diet"}},{"topic_slug":"resistance-training","is_published":true,"match_reasons":["Title contains controlled term: resistance training.","Abstract contains controlled term: resistance training.","Source terminology contains: resistance training.","Title supplies longevity context: elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Resistance training","slug":"resistance-training"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/277","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}