Study on Adherence to a Mediterranean Diet in a Population of Patients With Type 2 Diabetes Diet-Med
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- The percentage of patients adhering to the Mediterranean Diet
研究概览
简要总结
In randomized clinical studies, the mediterranean diet has demonstrated beneficial effects on glucose and lipids levels, on body composition, on waist to hip ratio, especially in patients with type 2 diabetes. Consequently, the meditteranean diet is now recommended by experts in cardiology, nutrition and diabetology. However, many of these publications have been generated in populations living around the Mediterranean Basin. Thus, it is not sure that this diet can be used by people living outside this geographic area. We aimed to study the capacity of consecutive patients admitted in diabetology to follow the mediterranean diet recommandations during 12 months. The adherence will be studied in the real life in order to identify all limitations to follow this diet. Therefore, this study may help to find solutions to reinforce adherence to this diet.
详细描述
Patients older than 18 years of age and consequently admitted in the Dpt of Diabetology in the Pitié-Salpêtrière and the Georges Pompidou Euopean Hospitals will be enroled in this study. After a survey of eating habits, the 14 items of the mediterranean diet (accordingly to Schröder H et al., J Nutr 2011) will be explained. Adherence to the diet is defined by the achievement of more than 9 items from the original list of 14 items. Adhesion to the diet will be studied à 3 and 12 months by questionnaires and the analysis of olive oil consumption (urine levels of hydroxytyrosol and alpha linoleic acid levels in bloood). Consequences of adhesion to the diet on body weight, body composition, glucose and lipids levels, HbA1c and liver enzymes in blood will be collected at 3 and 12 months. At the end of the study, patients will complete a semi-quantitative questionnaire with a sociologist in order to identify main limitations to achieve items of the diet.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years old.
- •Patient with type 2 diabetes regardless of the hypoglycaemic treatments used and their HbA1c level.
- •Patient referred to the Diabetology day hospital of the CHU Pitié-Salpêtrière and Nutrition of the HEGP for assessment of diabetes and/or for obesity assessment and dietary education as part of routine care.
- •Patient accepting the constraints of the protocol after explanation of it and not opposing to participate in it.
- •Patient benefiting from or entitled to health insurance coverage outside of the AME.
排除标准
- •Patient with current or recent infections (<10 days).
- •Patient with unstable neoplastic (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), hematological, psychiatric (with the exception of eating disorders (ED)).
- •Pregnant or breastfeeding patient.
- •Person under legal protection.
结局指标
主要结局
The percentage of patients adhering to the Mediterranean Diet
时间窗: 12 months
This pourcentage is defined as an adherence score ≥ 9 in response to the 14-item questionnaire adapted from Schröder H et al., J Nutr 2011
次要结局
- Association between adherence and variations in the values of blood alpha linolenic acid(at inclusion, at 3 months and at 12 months)
- Association between variations in blood alpha linolenic acid values compared to inclusion and the declaration of increased consumption of hazelnuts during follow-up.(at 3 and 12 months)
- Association between adherence and variations in the values of urinary hydroxytyrosol(at inclusion, at 3 months and at 12 months)
- Association between variations in blood alpha linolenic acid values compared to inclusion and the declaration of increased consumption of walnuts during follow-up.(at 3 and 12 months)
- Association between variations in urinary hydroxytyrosol values compared to inclusion and the declaration of an increase in olive oil consumption during follow-up.(at 3 months and 12 months)
- Describe the difficulties/barriers to the initiation of the Mediterranean Diet(at 12 months)
- Association between variations in blood alpha linolenic acid values compared to inclusion and the declaration of increased consumption of almonds during follow-up.(at 3 and 12 months)
- To study whether adherence at baseline predicts adherence to Mediterranean Diet.(at 3 months and 12 months)
- Study whether adherence to the Mediterranean Diet modifies the frequency of food consumption(during follow-up (12 months))
- Describe the difficulties/barriers to the initiation of the Mediterranean Diet(at Day 15, at Day 60 and at Day 180)