Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in Waist Circumference
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Nutritional Counseling (Behavioral)
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.
干预措施: Nutritional Counseling (Behavioral)
结局指标
主要结局
Change in Waist Circumference
时间窗: 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).
次要结局
- Percentage of body fat(The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months))
- Insulin Sensitivity(The outcome will be calculated at admission, visit 7 (3 months) and visit 10 (6 months))
- Lipid profile(The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months))
- Glycemic variability(The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months))
- Body Mass Index (BMI)(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.)
- Systolic and diastolic Blood pressure(The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months))
- Mediterranean Diet Score(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).)