High Protein Effect on Body Composition and Sarcopenia Markers in Older Patients With Type 2 Diabetes Mellitus
2022年7月8日 更新者：Vassilis Paschalis、National and Kapodistrian University of Athens
The Effect of High Protein on Body Composition and Markers of Sarcopenia in Patients With Type 2 Diabetes Mellitus
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.
研究概览
研究类型
介入性
注册 (预期的)
25
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Vassilis Paschalis, Phd
- 电话号码：0030 2107276033
- 邮箱：vpaschalis@phed.uoa.gr
学习地点
-
-
Attiki
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Athens、Attiki、希腊
- 招聘中
- National and Kapodistrian University of Athens
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接触：
- Vassilis Paschalis, PhD
- 电话号码：00302107276033
- 邮箱：vpaschalis@phed.uoa.gr
-
副研究员：
- Dionysia Argyropoulou, Msc
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首席研究员：
- Vassilis Paschalis, PhD
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- must have been diagnosed with type 2 diabetes mellitus during the last 5 years
- must have BMI 18.5-24.9
Exclusion Criteria:
- receive dietary supplements
- extreme dietary habits
- chronic inflammation disease
- cancer
- autoimmune disease
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：intervention group
Dietary intervention with protein intake 1.5 gr/kg/day
|
dietary plan having dietary protein of 1.5 gr/kg/day
|
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实验性的：control group
Dietary intervention with protein intake 0.8 gr/kg/day
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dietary plan having dietary protein of 0.8 gr/kg/day
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
skeletal muscle mass index
大体时间：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)
|
Week 0, week 12
|
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calf circumference
大体时间：Week 0, week 6, week 12
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Change from baseline in calf circumference and will be assessed by measuring tape
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Week 0, week 6, week 12
|
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handgrip strength
大体时间：Week 0, week 6, week 12
|
Change from baseline in handgrip strength and will be assessed by handgrip dynamometer
|
Week 0, week 6, week 12
|
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Sit to stand test
大体时间：Week 0, week 6, week 12
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Change from baseline in "Sit to stand" test which measures muscle functionality and will be assessed by chronometer
|
Week 0, week 6, week 12
|
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Timed up and go test
大体时间：Week 0, week 6, week 12
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Change from baseline in "Timed up and go" test which measures muscle functionality and will be assessed by chronometer
|
Week 0, week 6, week 12
|
|
10 meters walking test
大体时间：Week 0, week 6, week 12
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Change from baseline in 10 meters walking test which measures muscle functionality and will be assessed by chronometer
|
Week 0, week 6, week 12
|
|
blood glucose
大体时间：Week 0, week 6, week 12
|
Change from baseline in blood glucose and will be assessed by commercially available kit
|
Week 0, week 6, week 12
|
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Serum insulin
大体时间：Week 0, week 6, week 12
|
Change from baseline in serum insulin and will be assessed by commercially available kit
|
Week 0, week 6, week 12
|
|
Glycosylated hemoglobin (HbA1)
大体时间：Week 0, week 6, week 12
|
Change from baseline in HbA1 and will be assessed by commercially available kit
|
Week 0, week 6, week 12
|
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C reactive protein
大体时间：Week 0, week 6, week 12
|
Change from baseline in C reactive protein and will be assessed by commercially available kit
|
Week 0, week 6, week 12
|
|
Dietary intake of macro- and micro-nutrients
大体时间：Week 0, week 3 , week 6, week 9, week 12
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Change from baseline in macro- and micro- nutrients and will be assessed with -3 day recall
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Week 0, week 3 , week 6, week 9, week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
cholesterol level
大体时间：Week 0, week 6, week 12
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Change from baseline in cholesterol level and will be assessed by commercially available kit
|
Week 0, week 6, week 12
|
|
triglycerides level
大体时间：Week 0, week 6, week 12
|
Change from baseline in triglycerides level and will be assessed by commercially available kit
|
Week 0, week 6, week 12
|
|
low-density lipoprotein (LDL)
大体时间：Week 0, week 6, week 12
|
Change from baseline in LDL and will be assessed by commercially available kit
|
Week 0, week 6, week 12
|
|
high-density lipoprotein (HDL)
大体时间：Week 0, week 6, week 12
|
Change from baseline in HDL and will be assessed by commercially available kit
|
Week 0, week 6, week 12
|
|
Enzymatic activity of glutathione peroxidase in plasma
大体时间：Week 0, week 6, week 12
|
Change from baseline in enzymatic activity of glutathione peroxidase in plasma and will be assessed by commercially available kit
|
Week 0, week 6, week 12
|
|
Enzymatic activity of glutathione peroxidase in red blood cell lysate
大体时间：Week 0, week 6, week 12
|
Change from baseline in enzymatic activity of glutathione peroxidase in red blood cell lysate and will be assessed by commercially available kit
|
Week 0, week 6, week 12
|
|
Enzymatic activity of superoxide dismutase in plasma
大体时间：Week 0, week 6, week 12
|
Change from baseline in superoxide dismutase in plasma and will be assessed by commercially available kit
|
Week 0, week 6, week 12
|
|
Enzymatic activity of superoxide dismutase in red blood cell lysate
大体时间：Week 0, week 6, week 12
|
Change from baseline in superoxide dismutase in red blood cell lysate and will be assessed by commercially available kit
|
Week 0, week 6, week 12
|
|
Protein carbonyls in plasma
大体时间：Week 0, week 6, week 12
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Change from baseline in protein carbonyls in plasma and will be assessed by commercially available kit
|
Week 0, week 6, week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年11月1日
初级完成 (预期的)
2022年10月31日
研究完成 (预期的)
2022年10月31日
研究注册日期
首次提交
2022年7月8日
首先提交符合 QC 标准的
2022年7月8日
首次发布 (实际的)
2022年7月13日
研究记录更新
最后更新发布 (实际的)
2022年7月13日
上次提交的符合 QC 标准的更新
2022年7月8日
最后验证
2022年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
2型糖尿病的临床试验
1.5 protein的临床试验
-
University of Illinois at ChicagoRush University Medical Center; American Society for Parenteral and Enteral Nutrition完全的
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Société des Produits Nestlé (SPN)Nutrasource Pharmaceutical and Nutraceutical Services, Inc.; Bruyere Research Institute终止
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University of HohenheimUniversity Hospital Tuebingen完全的
-
U.S. Army Medical Research and Development Command完全的