Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome (MEDIT)
2019年1月29日 更新者：Institut de Recherches Cliniques de Montreal
Recent studies have found that up to 45 % of patients with type 1 diabetes have metabolic syndrome, a cluster of conditions (abdominal obesity, hypertension, dyslipidemia, insulin resistance) that increase the cardiovascular risk.
The investigators have observed in previous studies a strong association between the adherence to a Mediterranean diet and the prevalence of metabolic syndrome on patients with metabolic syndrome.
However, no intervention has been realized on this population and the current recommendations (low fat diet) differ from the Mediterranean diet.
A nutritional intervention on the principles of the Mediterranean diet could therefore play a role in the treatment of the metabolic syndrome in Type 1 diabetes patients.
The main objective of this study is to examine the impact of a nutritional intervention on the waist circumference after 6 months of an intervention group (Mediterranean diet) versus a control group (low fat diet).
研究概览
研究类型
介入性
注册 (实际的)
29
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。
学习地点
-
-
Quebec
-
Montréal、Quebec、加拿大、H2W1R7
- Institut de recherches cliniques de Montréal
-
-
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
18年 至 65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:
- Type 1 Diabetes for at least 12 months
- On intensive insulin therapy with multiple daily injections or on insulin pump
- Be overweight or obese (BMI≥25 kg/m2)
- Stable weight for at least 3 months
- If on medication for thyroid, hypertension or dislipidemia: stable doses in the last 3 months
Presenting at least 3 of the 5 following criteria for metabolic syndrome:
- Waist circumference >102cm ♂ or >88cm ♀
- Triglycerides >1.7mmol/L or medication
- Cholesterol-HDL <1.0mmol/L ♂ or <1.3mmol/L ♀ or medication
- Blood pressure ≥130/85 mmHg or medication
- Estimated insulin resistance (eGDR <6.29)
Exclusion Criteria:
- Mental incapacity, refusal or linguistic barrier that could affect comprehension or cooperation with the study
- Ongoing pregnancy
- Diet corresponding to the criteria of a mediterranean diet (score≥27)
- Vegetarianism
- Major diabetes complications
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：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：Mediterranean Diet
Participants will receive nutritional lessons on the principles of the Mediterranean diet.
This type of diet is defined with a carbohydrate intake of 45-55% of total energy intake, 15-20% of proteins, 30-35% of lipids and less than 7% for saturated fat.
Nine sessions with a nutritionist are planned to cover various topics of the diet.
|
Carbohydrate counting will be reviewed, as well as hypoglycemia management.
The 9 following visits will focus on different aspects of each diets: types of fats, meat and alternatives, grain products, milk and alternatives, fruits and vegetables, salt intake, energy density and restaurants.
|
|
安慰剂比较：Low Fat Diet
Participants will receive nutritional lessons on the principles of the low fat diet.
This type of diet is defined with a carbohydrate intake greater than 45% of total energy intake, 15-20% of proteins, less than 30% of lipids and less than 7% for saturated fat.
Nine sessions with a nutritionist are planned to cover various topics of the diet.
|
Carbohydrate counting will be reviewed, as well as hypoglycemia management.
The 9 following visits will focus on different aspects of each diets: types of fats, meat and alternatives, grain products, milk and alternatives, fruits and vegetables, salt intake, energy density and restaurants.
|
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 Waist Circumference
大体时间：Change from baseline and 6 months measure of waist circumference
|
The outcome will be measured every month, at admission and visits 4 (1 month) - 6 (2 months) -7 (3 months) -8 (4 months) -9 (5 months) -10 (6 months) -11 (9 months).
|
Change from baseline and 6 months measure of waist circumference
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mediterranean Diet Score
大体时间：The outcome will be measured based on an internet food frequency questionnaire filled by patients at admission, visit 7 (3 months) and visit 10 (6 months).
|
The questionnaire allows the calculation of a score reflecting the adherence to the mediterranean diet.
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The outcome will be measured based on an internet food frequency questionnaire filled by patients at admission, visit 7 (3 months) and visit 10 (6 months).
|
|
Body Mass Index (BMI)
大体时间：Weight wil be measured every month: at admission and visit 4 (1 month), 6 (2 months), 7 (3 months), 8 (4 months), 9 (5 months) and 10 (6 months). The height will be measured only at admission.
|
Weight (kg) / (height (m) x height (m))
|
Weight wil be measured every month: at admission and visit 4 (1 month), 6 (2 months), 7 (3 months), 8 (4 months), 9 (5 months) and 10 (6 months). The height will be measured only at admission.
|
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Percentage of body fat
大体时间：The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
|
The outcome will be measured using a DEXA-scan
|
The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
|
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Insulin Sensitivity
大体时间：The outcome will be calculated at admission, visit 7 (3 months) and visit 10 (6 months)
|
The outcome will be estimated based on a formula validated for type 1 diabetes subjects.
The formula takes into account waist/hip ratio, glycated hemoglobin and hypertension.
|
The outcome will be calculated at admission, visit 7 (3 months) and visit 10 (6 months)
|
|
Systolic and diastolic Blood pressure
大体时间：The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
|
Average of 3 measures (systolic, diastolic and pulse) after a 5 minutes resting period
|
The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
|
|
Lipid profile
大体时间：The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
|
A blood test will measure level of total cholesterol, triglycerides and LDL cholesterol.
|
The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
|
|
Glycemic variability
大体时间：The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
|
Glycated hemoglobin will be measured with a blood sample.
Hypoglycemia frequency will be measured with a 4-day glycemia journal.
|
The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
|
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。
调查人员
- 研究主任：Remi Rabasa-Lhoret、IRCM
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)
2016年1月1日
初级完成 (实际的)
2018年4月1日
研究完成 (实际的)
2018年4月1日
研究注册日期
首次提交
2016年6月20日
首先提交符合 QC 标准的
2016年6月29日
首次发布 (估计)
2016年7月1日
研究记录更新
最后更新发布 (实际的)
2019年1月31日
上次提交的符合 QC 标准的更新
2019年1月29日
最后验证
2017年9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.