The Relationship Between Diet and Glycemic Response and Inflammatory Markers in Children With Cystic Fibrosis

Sponsor
büşra başpınar (Other)
Overall Status
Recruiting
CT.gov ID
NCT05748444
Collaborator
(none)
24
1
3.9
6.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    24 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Relationship Between Diet and Glycemic Response and Inflammatory Markers in Children With Cystic Fibrosis
    Actual Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Children with cystic fibrosis

    Voluntary children with cystic fibrosis aged 6-18 years with normal glucose tolerance will be included in the study.

    Outcome Measures

    Primary Outcome Measures

    1. Pulmonary function test [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 ]

    2. Distance of shuttle walk test [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.

    3. Oral glucose tolerance test [14 days]

      The glucose values given in mmol/l after 30', 60', 90' and 120 minutes during OGTT.

    4. Continuous glucose monitoring system (Percentage of time spent above 8mmol/l) [14 days]

      Percentage of time spent above 8mmol/l. These measurement will be gained out of the 14 day CGMS-course

    5. Continuous glucose monitoring system (The area under the curve) [14 days]

      The area under the curve. These measurements will be gained out of the 14 day CGMS-course

    6. Continuous glucose monitoring system (The mean glucose value (in mmol/l)) [14 days]

      The mean glucose value (in mmol/l). These measurements will be gained out of the 14 day CGMS-course

    7. Weight in kilograms [30 days]

      Children's growth and development will be evaluated according to WHO's percentile scores.

    8. Height in meters [30 days]

      Children's growth and development will be evaluated according to WHO's percentile scores.

    9. Food record for three days [3 days]

      The food consumed by the children will be recorded for 3 days (on the days when the CGMS is installed).

    10. Serum C-reactive protein (CRP) [14 days]

      Participants' serum C-reactive protein (CRP) levels will be determined.

    11. Serum malondialdehyde (MDA) [14 days]

      Participants' serum malondialdehyde (MDA) levels will be determined.

    12. Serum Interleukin-1-beta (IL-1B) [14 days]

      Participants' serum Interleukin-1-beta (IL-1B) levels will be determined.

    13. Serum tumor necrosis factor-alpha (TNF-a) [14 days]

      Participants' serum tumor necrosis factor-alpha (TNF-a) levels will be determined.

    14. Serum interleukin-6 (IL-6) [14 days]

      Participants' serum interleukin-6 (IL-6) levels will be determined.

    15. Serum interferon-gamma [14 days]

      Participants' serum interferon-gamma levels will be determined.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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.
    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara University, Faculty of medicine Ankara Turkey 06080

    Sponsors and Collaborators

    • büşra başpınar

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    büşra başpınar, Busra Baspinar, Ankara University
    ClinicalTrials.gov Identifier:
    NCT05748444
    Other Study ID Numbers:
    • busrabasp92
    First Posted:
    Feb 28, 2023
    Last Update Posted:
    Feb 28, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by büşra başpınar, Busra Baspinar, Ankara University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 28, 2023