Completed

NCT Number: NCT04249466

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Pierre-Bénite, 69495, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: At baseline
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).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: MONA

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jan 31, 2020
Registry last updated: Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed