Diet, Physical Activity & Glucose Tolerance in Cystic Fibrosis.

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04249466
Study type	Observational
Source	Hospices Civils de Lyon
Contact
Status	Completed
Phase
Start date	June 5, 2020
Completion date	November 8, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Diet, Physical Activity and Glucose Tolerance in Cystic Fibrosis. Exploratory Study. — MONA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms