Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus (DiNA-D)
Dietary Strategies to Improve Metabolism and Body Weight in Type 2 Diabetes
Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.
The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.
研究概览
详细说明
Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.
The researchers therefore investigate dietary strategies such as low-carb diets and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.
An intensive intervention of 3 weeks is followed by an 11-month maintenance phase to consolidate metabolic improvements.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Stefan Kabisch, Dr. med.
- 电话号码：429 030 450 514
- 邮箱：stefan.kabisch@dife.de
研究联系人备份
- 姓名：June Inderthal
- 电话号码：033 200 88 2771
- 邮箱：june.inderthal@dife.de
学习地点
-
-
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Berlin、德国、12203
- 招聘中
- German Institute for Human Nutrition, Department for Clinical Nutrition
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接触：
- Stefan Kabisch, Dr. med.
- 电话号码：429 030 450 514
- 邮箱：stefan.kabisch@charite.de
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接触：
- Ulrike Kaiser, M.sc.
- 电话号码：428 030 450 514
- 邮箱：ulrike.kaiser@charite.de
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副研究员：
- Stefan Kabisch, Dr. med.
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副研究员：
- Ulrike Kaiser, M.sc.
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Brandenburg
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Bergholz-Rehbrücke、Brandenburg、德国、14458
- 尚未招聘
- German Institut for Human Nutrition; Department for Clinical Nutrition
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接触：
- Margrit Kemper, Dr. med.
- 电话号码：033200 88 2775
- 邮箱：margrit.kemper@dife.de
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接触：
- Silke Hornemann
- 电话号码：033200 88 2779
- 邮箱：silke.hornemann@dife.de
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副研究员：
- Margrit Kemper, Dr. med.
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副研究员：
- Silke Hornemann
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副研究员：
- Christiana Gerbracht, Dr.
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- male and female subjects
- 18-79 years old
- type 2 diabetes
Exclusion Criteria:
- renal insufficiency
- anaemia
- immunosuppression
- previous symptomatic cancer diagnosis
- acute cardiovascular disease (stroke, coronary syndrome)
- pregnancy and lactation
- severe psychiatric disorders
- corticoid or other immunosuppressive therapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：low-carb diet, followed by conventional DGE diet
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory low-carb ketogenic diet (VLCKD, below 40 g carbs per day), followed by an isocaloric or moderate hypocaloric low-carb diet (below 40 kcal% carbs per day)
|
first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
|
|
有源比较器：very-low calory diet, followed by conventional diet
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory diet (VLCD; MODIFAST substitute, approx.
1200 kcal/day), followed by a conventional isocaloric or moderate hypocaloric diet under DGE guidelines
|
first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
|
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 |
|---|---|---|
|
change in insulin secretion (glucagon stimulation test)
大体时间：3 weeks, 1 year
|
change in insulin secretion (glucagon stimulation test)
|
3 weeks, 1 year
|
|
change in hepatic fat content (MR-S)
大体时间：3 weeks, 1 year
|
change in hepatic fat content (MR-S)
|
3 weeks, 1 year
|
|
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
大体时间：3 weeks, 1 year
|
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
|
3 weeks, 1 year
|
|
change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
大体时间：3 weeks, 1 year
|
change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
|
3 weeks, 1 year
|
|
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
大体时间：3 weeks, 1 year
|
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
|
3 weeks, 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)
大体时间：3 weeks, 1 year
|
inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level)
|
3 weeks, 1 year
|
|
change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds
大体时间：3 weeks, 1 year
|
peripheral neuropathy
|
3 weeks, 1 year
|
|
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)
大体时间：3 weeks, 1 year
|
autonomic neuropathy
|
3 weeks, 1 year
|
合作者和调查者
合作者
调查人员
- 首席研究员：Andreas F.H. Pfeiffer, Prof. Dr. med.、German Institute of Human Nutrition
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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