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

NCT04249466 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2023-03-14

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Questionnaire

During this consult, several parameters will be measured : * nutritional and physical activity parameters: Food Frequency Questionnaire (FFQ), International Physical Activity Questionnaire (IPAQ), Three-Factor Eating Questionnaire (TFEQ-R18), impedance test, anthropometric measurements, resting energy expenditure * demographic and clinical parameters : Family history, date of birth (month and year), sex, genotype, best forced expiratory volume (FEV) (over the 12 months preceding inclusion), bacterial colonization * patient treatment and biologic parameters: corticosteroid therapy (with dosage, over the 12 months preceding inclusion), antidiabetic treatment (oral or insulin), IV antibiotic treatment, corrective treatments, pancreatic enzymes, OGTT (blood glucose and insulin levels at three times), lipid balance, vitamin dosage.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-05
Primary Completion
2021-11-08
Completion
2021-11-08

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04249466 on ClinicalTrials.gov