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

NCT04249466 | Completed

• 1 other identifier: 69HCL18_0698
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Measurement of glycemia and insulinemia at T0, T60 and T120 min

  Glucose tolerance is the factor studied. It's established on the basis of Oral Glucose Tolerance Test (OGTT) data, with measurement of glycemia and insulinemia at T0, T60 and T120 min. Carbohydrate status will be determined using the international classification: * Normal Glucose Tolerance (NGT) (G0 ≤ 7.0 mmol / L and G2 ≤ 7.7 mmol / L), * Abnormal glucose tolerance (AGT) defined by indeterminate status (INDET) (G0 ≤ 7.0 mmol / L and G2 ≤ 7.7 mmol / L, but G1 ≥ 11.1 mmol / L) or Impaired Glucose Tolerance (IGT) (G0 ≤ 7.0 mmol / L and G2\> 7.7 mmol / L but \<11.1 mmol / L) * Diabetic status (CFRD) (G0\> 7.0 mmol / L or G2 ≥ 11.1 mmol / L).

  At baseline

Study Arms (1)

Patient with cystic fibrosis

Other: Questionnaire

Interventions

Questionnaire OTHER

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.

Patient with cystic fibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient (male or female) with cystic fibrosis or pancreatic insufficiency aged 18 years and over will answer a questionnaire to identify them in terms of: * Nutritional profile * Eating behaviour * Physical activity * Resting energy expenditure * Body composition

You may qualify if:

• patient (male or female) with cystic fibrosis aged 18 years and over
• pancreatic insufficiency
• followed at the CRCM adult in Lyon
• patient able to understand the information given to him
• patient having previously had a medical examination during the selection visit

You may not qualify if:

• FEV \< 30%
• lung transplant
• patient treated with insulin
• parenteral feeding on nasogastric tube or gastrostomy
• patient under guardianship or protected by law
• patient deprived of his liberty by judicial or administrative decision
• patient currently in an another clinical study

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de médecine interne - CRCM Lyon Adultes, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: June 5, 2020
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

FR (1)