Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT04249466
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2020-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diet, Physical Activity and Glucose Tolerance in Cystic Fibrosis. Exploratory Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2020-01-29', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of glycemia and insulinemia at T0, T60 and T120 min', 'timeFrame': 'At baseline', 'description': "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.\n\nCarbohydrate status will be determined using the international classification:\n\n* Normal Glucose Tolerance (NGT) (G0 ≤ 7.0 mmol / L and G2 ≤ 7.7 mmol / L),\n* 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)\n* Diabetic status (CFRD) (G0\\> 7.0 mmol / L or G2 ≥ 11.1 mmol / L)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Background :\n\nDiabetes 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).\n\nGiven 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.\n\nObjectives of the study :\n\n\\- Main objective :\n\nTo describe adult patients with cystic fibrosis in terms of :\n\n* Nutritional profile\n* Food behaviour\n* Physical activity\n* Rest energy expenditure\n* Body composition - Secondary objectives : To research the association between the nutritional profile and the glucose tolerance.', 'detailedDescription': "Study design :\n\nThe 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.\n\nExpected results\n\nThe expected results are:\n\n* Identify the inter-relationships between nutritional profile and glucose tolerance in adult patients with cystic fibrosis\n* Describe the body composition and consumption on resting energy of adults with cystic fibrosis\n\nThe perspectives are:\n\n* Propose nutritional and dietetic measures to limit the deterioration of the glucose tolerance in adult patients with cystic fibrosis\n* 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\n\nThe research perspectives are to compare adult patients with cystic fibrosis followed in France and Quebec in terms of:\n\n* nutritional profiles, nutritional quality index of food and eating behaviours, resting energy expenditure, body composition\n* nutritional medical practices (dietary monitoring, recommendations given to patients, intake of pancreatic enzyme)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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:\n\n* Nutritional profile\n* Eating behaviour\n* Physical activity\n* Resting energy expenditure\n* Body composition', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient (male or female) with cystic fibrosis aged 18 years and over\n* pancreatic insufficiency\n* followed at the CRCM adult in Lyon\n* patient able to understand the information given to him\n* patient having previously had a medical examination during the selection visit\n\nExclusion Criteria:\n\n* FEV \\< 30%\n* lung transplant\n* patient treated with insulin\n* parenteral feeding on nasogastric tube or gastrostomy\n* patient under guardianship or protected by law\n* patient deprived of his liberty by judicial or administrative decision\n* patient currently in an another clinical study'}, 'identificationModule': {'nctId': 'NCT04249466', 'acronym': 'MONA', 'briefTitle': 'Diet, Physical Activity and Glucose Tolerance in Cystic Fibrosis. Exploratory Study.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Diet, Physical Activity and Glucose Tolerance in Cystic Fibrosis. Exploratory Study.', 'orgStudyIdInfo': {'id': '69HCL18_0698'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with cystic fibrosis', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'During this consult, several parameters will be measured :\n\n* 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\n* 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\n* 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.', 'armGroupLabels': ['Patient with cystic fibrosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Service de médecine interne - CRCM Lyon Adultes, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}