Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT05292833
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2022-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Adherence to a Mediterranean Diet in a Population of Patients With Type 2 Diabetes
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Study on Adherence to a Mediterranean Diet in a Population of Patients With Type 2 Diabetes Diet-Med
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIET-MED
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-A00766-35 | OTHER | IDRCB | View |