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)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- A composite of metabolic and functional indices
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Allocation concealment and blinding of primary outcome assessors will be implemented
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%.
排除标准
- •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.
研究组 & 干预措施
Circuit resistance training (CRT)
2-3 circuits * 10 exercises * 3 times per week
干预措施: Circuit resistance training (CRT) (Behavioral)
Empagliflozin 10 MG
10 mg once daily
干预措施: Empagliflozin 10 MG (Drug)
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.
干预措施: Vegeterranean diet (V-Med diet) (Behavioral)
结局指标
主要结局
A composite of metabolic and functional indices
时间窗: After 10 weeks (for all 3 arms) and after 20 weeks (for diet and drug arms only)
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).
次要结局
- 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))