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

Cystic Fibrosis Clinical Trial

— MONA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249466
• Other study ID #: 69HCL18_0698
• Status: Completed
• Start date: June 5, 2020
• Est. completion date: November 8, 2021

Study information

• Verified date: March 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.

Locations

Country	Name	City	State
France	Service de médecine interne - CRCM Lyon Adultes, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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