Mediterranean Diet, Circuit Resistance Training, Empagliflozin in Elderly With Type 2 Diabetes: a Study Protocol
- Conditions
- SarcopeniaWeight LossFrailtyDiabetes Mellitus, Type 2
- Interventions
- Behavioral: Vegeterranean diet (V-Med diet)Behavioral: Circuit resistance training (CRT)
- Registration Number
- NCT03560375
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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%.
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vegeterranean diet (V-Med diet) Vegeterranean diet (V-Med diet) 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. Empagliflozin 10 MG Empagliflozin 10 MG 10 mg once daily Circuit resistance training (CRT) Circuit resistance training (CRT) 2-3 circuits \* 10 exercises \* 3 times per week
- Primary Outcome Measures
Name Time Method Change in body weight After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only) Using the In-Body (720) body composition analyzer. Change in body weight (%) will be calculated as body weight at the end of 10 weeks (and 20 weeks) minus baseline body weight divided by body weight at baseline and multiplied by 100.
- Secondary Outcome Measures
Name Time Method Change in fasting plasma glucose After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only) 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.
Change in sarcopenia After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only) 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
Change in strength After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only) 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.
Relative lean mass change after 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only) 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
Change in frailty syndrome After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only) Will be assessed using a modification of the Fried assessment (Fried LP et al. J Gerontol A Biol Sci Med Sci. 2001 Mar 1;56(3):M146-57) based on low hand grip strength, low four meters average walking speed, low caloric expenditure on physical activity, self-reporting of extreme fatigue or low functionality and a spontaneous reduction of at least 4.5 kg in the past year. In this method, the low hand grip criterion is met when grip strength, assessed as the average of 3 readings of the dominant hand by a handheld dynamometer is less than or equal to the sex- and body mass index-specific cutoff points provided by Fried et al. The slow gait speed criterion is met if the participant scored more than 4 seconds. Frailty scores range from 0 to 5 (ie, 1 point for each component; 0 = best score, 5 = worst score) and are further categorized into: frail (3-5), pre-frail (1-2), and robust (0). Frailty change will be considered as "improved vs. not improved"; change from one level to the other.
Trial Locations
- Locations (1)
The Institute of Endocrinology Metabolism and Hypertension
🇮🇱Tel Aviv, Israel