Cystic FibrosisNCT05748444
The Relationship Between Diet and Glycemic Response and Inflammatory Markers in Children With Cystic Fibrosis
An observational study of Cystic Fibrosis and Glucose Metabolism Disorders, run by büşra başpınar at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the relationship between diets of children with cystic fibrosis and glycemic responses and some inflammatory markers. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cystic Fibrosis, Glucose Metabolism Disorders
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Aug 2024
- How long will I take part?
- 14 Days
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with cystic fibrosis between the ages of 6 and 18 with normal glucose tolerance will be included in the study.
Who may be able to join
- A child with cystic fibrosis between the ages of 6 and 18 who had normal glucose tolerance and volunteered to participate in the study will be included in the study.
Who cannot join
- Children with known chronic diseases such as diabetes, thyroid, liver disease (hepatitis, cirrhosis, etc.), hospitalization and/or surgery at least one month before the start of the study,
- Children who use oral/inhaled steroids, use oral antidiabetic agents, use insulin in the last month,
- Children who have had allergic bronchopulmonary aspergillosis, using intravenous or oral/inhaled antibiotic drugs at least one month ago,
- Children who wear the continuous glucose monitoring sensor for less than three days and do not keep a record of food consumption during the time it is worn
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University, Faculty of medicine
Ankara, 06080
büşra başpınar, +905534375414, busrabaspinar92@gmail.com
About this study
The aim of this study is to determine the relationship between diets of children with cystic fibrosis and glycemic responses and some inflammatory markers.
Read the detailed description
Cystic fibrosis is an autosomal recessive genetic disease; thick, sticky mucus accumulates in the mucin-secreting organs due to the absence or dysfunction of the cystic fibrosis transmembrane regülatör (CFTR) protein. The most commonly affected organ is the lung and the respiratory system disorder is the leading cause of death in patients with cystic fibrosis (CF). Pancreatic insufficiency is also a frequent complication in this patient group in older ages and significantly reduces life expectancy. It is argued that growth and development are adversely affected even in the stages before pancreatic insufficiency occurs. The challenges in the treatment of CFRD include dealing with increased caloric requirements for people with CF, resulting in high carbohydrate intake and frequent snacking, which exacerbates hyperglycemia. This situation causes difficulty in providing glycemic control in patients. In addition, decreased insulin secretion, as well as increased insulin resistance, delay the response to dietary glucose. This leads to an excursion of blood glucose and impaired respiratory function during the day. In addition, increased inflammation exacerbates pancreatic damage. The aim of this study is to determine the relationship between the diets of children with cystic fibrosis and glycemic responses and some inflammatory markers. In this study, general information and anthropometric measurements of patients with cystic fibrosis aged 6-18 will be recorded and their growth and development will be evaluated. With the continuous glucose monitoring system (CGMS) of the participants, the times (at least three, maximum fourteen days) when the blood glucose is below and above the target, the time in the target interval, and glucose fluctuations will be monitored. During the days of monitoring, total energy, macro-micronutrients intakes, glycemic index, and load will be calculated by asking individuals to keep a record of food consumption. The data obtained from the study will be evaluated with the SPSS package program using appropriate statistical analysis.
- Conditions
- Cystic Fibrosis, Glucose Metabolism Disorders
- Keywords
- Inflammation, Cystic fibrosis, Glycemic response, Diet, Glycemic index, Blood glucose excursion, Inflammatory markers
- Medical subject headings
- Cystic Fibrosis, Glucose Metabolism Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with cystic fibrosis | Voluntary children with cystic fibrosis aged 6-18 years with normal glucose tolerance will be included in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function test
FEV1% (forced expiratory volume at one second) out of the lung function testing [ Time Frame: Within 3 months of the 7 day course of CGMS ]
Measured: 90 days
Distance of shuttle walk test
Distance of shuttle walk test will be walked by children with cystic fibrosis. Shuttle walk test is made on floor with ten meters distance. Speed is determined according to signals from CD player.
Measured: 90 days
Oral glucose tolerance test
The glucose values given in mmol/l after 30', 60', 90' and 120 minutes during OGTT.
Measured: 14 days
Continuous glucose monitoring system (Percentage of time spent above 8mmol/l)
Percentage of time spent above 8mmol/l. These measurement will be gained out of the 14 day CGMS-course
Measured: 14 days
Continuous glucose monitoring system (The area under the curve)
The area under the curve. These measurements will be gained out of the 14 day CGMS-course
Measured: 14 days
Continuous glucose monitoring system (The mean glucose value (in mmol/l))
The mean glucose value (in mmol/l). These measurements will be gained out of the 14 day CGMS-course
Measured: 14 days
Weight in kilograms
Children's growth and development will be evaluated according to WHO's percentile scores.
Measured: 30 days
Height in meters
Children's growth and development will be evaluated according to WHO's percentile scores.
Measured: 30 days
Food record for three days
The food consumed by the children will be recorded for 3 days (on the days when the CGMS is installed).
Measured: 3 days
Serum C-reactive protein (CRP)
Participants' serum C-reactive protein (CRP) levels will be determined.
Measured: 14 days
Serum malondialdehyde (MDA)
Participants' serum malondialdehyde (MDA) levels will be determined.
Measured: 14 days
Serum Interleukin-1-beta (IL-1B)
Participants' serum Interleukin-1-beta (IL-1B) levels will be determined.
Measured: 14 days
Serum tumor necrosis factor-alpha (TNF-a)
Participants' serum tumor necrosis factor-alpha (TNF-a) levels will be determined.
Measured: 14 days
Serum interleukin-6 (IL-6)
Participants' serum interleukin-6 (IL-6) levels will be determined.
Measured: 14 days
Serum interferon-gamma
Participants' serum interferon-gamma levels will be determined.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Jan 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- büşra başpınar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, büşra başpınar, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748444
- Sponsor's protocol ID
- busrabasp92
- Status last verified
- Jul 2023
- First submitted
- 24 Jan 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Diet and Glycemic Response and Inflammatory Markers in Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05748444
- Acronym / sponsor ID
- busrabasp92
- Conditions
- Cystic Fibrosis, Glucose Metabolism Disorders
- Keywords
- Inflammation, Cystic fibrosis, Glycemic response, Diet, Glycemic index, Blood glucose excursion, Inflammatory markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- büşra başpınarUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 28 Feb 2023 (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.
The aim of this study is to determine the relationship between diets of children with cystic fibrosis and glycemic responses and some inflammatory markers.
Detailed description
Cystic fibrosis is an autosomal recessive genetic disease; thick, sticky mucus accumulates in the mucin-secreting organs due to the absence or dysfunction of the cystic fibrosis transmembrane regülatör (CFTR) protein. The most commonly affected organ is the lung and the respiratory system disorder is the leading cause of death in patients with cystic fibrosis (CF). Pancreatic insufficiency is also a frequent complication in this patient group in older ages and significantly reduces life expectancy. It is argued that growth and development are adversely affected even in the stages before pancreatic insufficiency occurs. The challenges in the treatment of CFRD include dealing with increased caloric requirements for people with CF, resulting in high carbohydrate intake and frequent snacking, which exacerbates hyperglycemia. This situation causes difficulty in providing glycemic control in patients. In addition, decreased insulin secretion, as well as increased insulin resistance, delay the response to dietary glucose. This leads to an excursion of blood glucose and impaired respiratory function during the day. In addition, increased inflammation exacerbates pancreatic damage. The aim of this study is to determine the relationship between the diets of children with cystic fibrosis and glycemic responses and some inflammatory markers. In this study, general information and anthropometric measurements of patients with cystic fibrosis aged 6-18 will be recorded and their growth and development will be evaluated. With the continuous glucose monitoring system (CGMS) of the participants, the times (at least three, maximum fourteen days) when the blood glucose is below and above the target, the time in the target interval, and glucose fluctuations will be monitored. During the days of monitoring, total energy, macro-micronutrients intakes, glycemic index, and load will be calculated by asking individuals to keep a record of food consumption. The data obtained from the study will be evaluated with the SPSS package program using appropriate statistical analysis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 14 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cystic fibrosis | – | –Voluntary children with cystic fibrosis aged 6-18 years with normal glucose tolerance will be included in the study. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with cystic fibrosis between the ages of 6 and 18 with normal glucose tolerance will be included in the study.
Key inclusion criteria (1 listed)
- A child with cystic fibrosis between the ages of 6 and 18 who had normal glucose tolerance and volunteered to participate in the study will be included in the study.
Key exclusion criteria (4 listed)
- Children with known chronic diseases such as diabetes, thyroid, liver disease (hepatitis, cirrhosis, etc.), hospitalization and/or surgery at least one month before the start of the study,
- Children who use oral/inhaled steroids, use oral antidiabetic agents, use insulin in the last month,
- Children who have had allergic bronchopulmonary aspergillosis, using intravenous or oral/inhaled antibiotic drugs at least one month ago,
- Children who wear the continuous glucose monitoring sensor for less than three days and do not keep a record of food consumption during the time it is worn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary function test
Time frame: 90 days
FEV1% (forced expiratory volume at one second) out of the lung function testing [ Time Frame: Within 3 months of the 7 day course of CGMS ]
Distance of shuttle walk test
Time frame: 90 days
Distance of shuttle walk test will be walked by children with cystic fibrosis. Shuttle walk test is made on floor with ten meters distance. Speed is determined according to signals from CD player.
Oral glucose tolerance test
Time frame: 14 days
The glucose values given in mmol/l after 30', 60', 90' and 120 minutes during OGTT.
Continuous glucose monitoring system (Percentage of time spent above 8mmol/l)
Time frame: 14 days
Percentage of time spent above 8mmol/l. These measurement will be gained out of the 14 day CGMS-course
Continuous glucose monitoring system (The area under the curve)
Time frame: 14 days
The area under the curve. These measurements will be gained out of the 14 day CGMS-course
Continuous glucose monitoring system (The mean glucose value (in mmol/l))
Time frame: 14 days
The mean glucose value (in mmol/l). These measurements will be gained out of the 14 day CGMS-course
Weight in kilograms
Time frame: 30 days
Children's growth and development will be evaluated according to WHO's percentile scores.
Height in meters
Time frame: 30 days
Children's growth and development will be evaluated according to WHO's percentile scores.
Food record for three days
Time frame: 3 days
The food consumed by the children will be recorded for 3 days (on the days when the CGMS is installed).
Serum C-reactive protein (CRP)
Time frame: 14 days
Participants' serum C-reactive protein (CRP) levels will be determined.
Serum malondialdehyde (MDA)
Time frame: 14 days
Participants' serum malondialdehyde (MDA) levels will be determined.
Serum Interleukin-1-beta (IL-1B)
Time frame: 14 days
Participants' serum Interleukin-1-beta (IL-1B) levels will be determined.
Serum tumor necrosis factor-alpha (TNF-a)
Time frame: 14 days
Participants' serum tumor necrosis factor-alpha (TNF-a) levels will be determined.
Serum interleukin-6 (IL-6)
Time frame: 14 days
Participants' serum interleukin-6 (IL-6) levels will be determined.
Serum interferon-gamma
Time frame: 14 days
Participants' serum interferon-gamma levels will be determined.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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.
Ankara University, Faculty of medicine
Ankara, Turkey (Türkiye)
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 and Glucose Metabolism Disorders, run by büşra başpınar at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Jul 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function test (time frame: 90 days). The study lists 15 primary outcomes in all. 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 21 Jul 2023.