Cystic FibrosisMONANCT04249466
Diet, Physical Activity and Glucose Tolerance in Cystic Fibrosis. Exploratory Study.
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Questionnaire
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2020to 8 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de médecine interne - CRCM Lyon Adultes, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69495
About this 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).
Read more
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.
Read the detailed 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).
- Conditions
- Cystic Fibrosis
- Being tested
- Questionnaire
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient with cystic fibrosis | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start5 Jun 2020
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249466
- Sponsor's protocol ID
- 69HCL18_0698
- Acronym
- MONA
- Status last verified
- Mar 2023
- First submitted
- 29 Jan 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet, Physical Activity and Glucose Tolerance in Cystic Fibrosis. Exploratory Study.
- ClinicalTrials.gov ID
- NCT04249466
- Acronym / sponsor ID
- MONA / 69HCL18_0698
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with cystic fibrosis | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- FEV < 30%
- lung transplant
- patient treated with insulin
- parenteral feeding on nasogastric tube or gastrostomy
- patient under guardianship or protected by law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireDuring 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. | Other | Patient with cystic fibrosis |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of glycemia and insulinemia at T0, T60 and T120 min (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.