Clinical trial NCT05748444: The Relationship Between Diet and Glycemic Response and Inflammatory Markers in Children With Cystic Fibrosis
Official title: The Relationship Between Diet and Glycemic Response and Inflammatory Markers in Children With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis
Glucose Metabolism Disorders
Keywords: Inflammation
Cystic fibrosis
Glycemic response
Diet
Glycemic index
Blood glucose excursion
Inflammatory markers
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with cystic fibrosis between the ages of 6 and 18 with normal glucose tolerance will be included in the study.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulmonary function test
timeFrame: 90 days
measure: Distance of shuttle walk test
timeFrame: 90 days
measure: Oral glucose tolerance test
timeFrame: 14 days
measure: Continuous glucose monitoring system (Percentage of time spent above 8mmol/l)
timeFrame: 14 days
measure: Continuous glucose monitoring system (The area under the curve)
timeFrame: 14 days
measure: Continuous glucose monitoring system (The mean glucose value (in mmol/l))
timeFrame: 14 days
measure: Weight in kilograms
timeFrame: 30 days
measure: Height in meters
timeFrame: 30 days
measure: Food record for three days
timeFrame: 3 days
measure: Serum C-reactive protein (CRP)
timeFrame: 14 days
measure: Serum malondialdehyde (MDA)
timeFrame: 14 days
measure: Serum Interleukin-1-beta (IL-1B)
timeFrame: 14 days
measure: Serum tumor necrosis factor-alpha (TNF-a)
timeFrame: 14 days
measure: Serum interleukin-6 (IL-6)
timeFrame: 14 days
measure: Serum interferon-gamma
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University, Faculty of medicine
Study officials:
References: