Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
Study NCT ID:
NCT04249466
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2020-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diet, Physical Activity and Glucose Tolerance in Cystic Fibrosis. Exploratory Study.
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
Diet, Physical Activity and Glucose Tolerance in Cystic Fibrosis. Exploratory Study.
Status:
COMPLETED
Status Verified Date:
2023-03
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:
MONA
Brief Summary:
Background :
Diabetes is correlated to an increase in patient morbidity and mortality. The pathophysiology of diabetes is still poorly understood. Significant variations in blood sugar have been shown over time in patients with cystic fibrosis with or without diabetes. No study has evaluated the association between the nutritional profile and the glucose tolerance in adult with cystic fibrosis, by integrating data on energy consumption (detailed nutritional profile) and energy expenditure (rest energy expenditure, body composition, and physical activity).
Given the epidemiological changes in cystic fibrosis correlated to the increased prevalence of diabetes and the clinical impact of nutritional status, the association between these factors remains to be studied.
Objectives of the study :
\- Main objective :
To describe adult patients with cystic fibrosis in terms of :
* Nutritional profile
* Food behaviour
* Physical activity
* Rest energy expenditure
* Body composition - Secondary objectives : To research the association between the nutritional profile and the glucose tolerance.
Diabetes is correlated to an increase in patient morbidity and mortality. The pathophysiology of diabetes is still poorly understood. Significant variations in blood sugar have been shown over time in patients with cystic fibrosis with or without diabetes. No study has evaluated the association between the nutritional profile and the glucose tolerance in adult with cystic fibrosis, by integrating data on energy consumption (detailed nutritional profile) and energy expenditure (rest energy expenditure, body composition, and physical activity).
Given the epidemiological changes in cystic fibrosis correlated to the increased prevalence of diabetes and the clinical impact of nutritional status, the association between these factors remains to be studied.
Objectives of the study :
\- Main objective :
To describe adult patients with cystic fibrosis in terms of :
* Nutritional profile
* Food behaviour
* Physical activity
* Rest energy expenditure
* Body composition - Secondary objectives : To research the association between the nutritional profile and the glucose tolerance.
Detailed Description:
Study design :
The study will last 12 months. It's an observational cross-sectional study; patients are include during a scheduled review at the Cystic Fibrosis Resource and Competence Centre (CRCM de Lyon) and their participation lasts only one day. The inclusion period will last 12 months.
Expected results
The expected results are:
* Identify the inter-relationships between nutritional profile and glucose tolerance in adult patients with cystic fibrosis
* Describe the body composition and consumption on resting energy of adults with cystic fibrosis
The perspectives are:
* Propose nutritional and dietetic measures to limit the deterioration of the glucose tolerance in adult patients with cystic fibrosis
* Develop equations for evaluating consumption on resting energy specific to adult patients with cystic fibrosis in order to more specifically adapt the nutritional recommendations to each patient
The research perspectives are to compare adult patients with cystic fibrosis followed in France and Quebec in terms of:
* nutritional profiles, nutritional quality index of food and eating behaviours, resting energy expenditure, body composition
* nutritional medical practices (dietary monitoring, recommendations given to patients, intake of pancreatic enzyme).
The study will last 12 months. It's an observational cross-sectional study; patients are include during a scheduled review at the Cystic Fibrosis Resource and Competence Centre (CRCM de Lyon) and their participation lasts only one day. The inclusion period will last 12 months.
Expected results
The expected results are:
* Identify the inter-relationships between nutritional profile and glucose tolerance in adult patients with cystic fibrosis
* Describe the body composition and consumption on resting energy of adults with cystic fibrosis
The perspectives are:
* Propose nutritional and dietetic measures to limit the deterioration of the glucose tolerance in adult patients with cystic fibrosis
* Develop equations for evaluating consumption on resting energy specific to adult patients with cystic fibrosis in order to more specifically adapt the nutritional recommendations to each patient
The research perspectives are to compare adult patients with cystic fibrosis followed in France and Quebec in terms of:
* nutritional profiles, nutritional quality index of food and eating behaviours, resting energy expenditure, body composition
* nutritional medical practices (dietary monitoring, recommendations given to patients, intake of pancreatic enzyme).
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?: