The Effect of High Protein on Body Composition and Markers of Sarcopenia in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- C reactive protein
研究概览
简要总结
This study will investigate the impact of dietary protein intake on progressive muscle loss and functionality (sarcopenia) in older adults with type 2 diabetes mellitus. Sarcopenia is known to have a bidirectional interaction with type 2 diabetes mellitus. Therefore in order to address this bidirectional complication we suggest that an increased intake of dietary protein at 1.5 gr/kg/day (current official recommendation is 0.8 gr/kg/day) could help to treat the sarcopenia, which in turn will help to ameliorate the type 2 diabetes mellitus progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must have been diagnosed with type 2 diabetes mellitus during the last 5 years
- •must have BMI 18.5-34.9
排除标准
- •receive dietary supplements
- •extreme dietary habits
- •chronic inflammation disease
- •autoimmune disease
研究组 & 干预措施
intervention group
Dietary intervention with protein intake 1.5 gr/kg/day
干预措施: 1.5 protein (Other)
control group
Dietary intervention with protein intake 0.8 gr/kg/day
干预措施: 0.8 protein (Other)
结局指标
主要结局
C reactive protein
时间窗: Week 0, week 6, week 12
Change from baseline in C reactive protein and will be assessed by commercially available kit
Dietary intake of macro- and micro-nutrients
时间窗: Week 0, week 3 , week 6, week 9, week 12
Change from baseline in macro- and micro- nutrients and will be assessed with -3 day recall
handgrip strength
时间窗: Week 0, week 6, week 12
Change from baseline in handgrip strength and will be assessed by handgrip dynamometer
Sit to stand test
时间窗: Week 0, week 6, week 12
Change from baseline in "Sit to stand" test which measures muscle functionality and will be assessed by chronometer
blood glucose
时间窗: Week 0, week 6, week 12
Change from baseline in blood glucose and will be assessed by commercially available kit
skeletal muscle mass index
时间窗: Week 0, week 12
Change from baseline in skeletal muscle mass index and will be assessed by dual energy x-ray absorptiometry ((leg lean mass+arm lean mass)/height\^2)
calf circumference
时间窗: Week 0, week 6, week 12
Change from baseline in calf circumference and will be assessed by measuring tape
Timed up and go test
时间窗: Week 0, week 6, week 12
Change from baseline in "Timed up and go" test which measures muscle functionality and will be assessed by chronometer
10 meters walking test
时间窗: Week 0, week 6, week 12
Change from baseline in 10 meters walking test which measures muscle functionality and will be assessed by chronometer
Serum insulin
时间窗: Week 0, week 6, week 12
Change from baseline in serum insulin and will be assessed by commercially available kit
Glycosylated hemoglobin (HbA1)
时间窗: Week 0, week 6, week 12
Change from baseline in HbA1 and will be assessed by commercially available kit
次要结局
- low-density lipoprotein (LDL)(Week 0, week 6, week 12)
- high-density lipoprotein (HDL)(Week 0, week 6, week 12)
- Enzymatic activity of glutathione peroxidase in red blood cell lysate(Week 0, week 6, week 12)
- Enzymatic activity of superoxide dismutase in plasma(Week 0, week 6, week 12)
- triglycerides level(Week 0, week 6, week 12)
- Enzymatic activity of glutathione peroxidase in plasma(Week 0, week 6, week 12)
- cholesterol level(Week 0, week 6, week 12)
- Enzymatic activity of superoxide dismutase in red blood cell lysate(Week 0, week 6, week 12)
- Protein carbonyls in plasma(Week 0, week 6, week 12)
研究者
Vassilis Paschalis
Professor
National and Kapodistrian University of Athens