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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05748444
• Other study ID #: busrabasp92
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2023
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Glucose Metabolism Disorders
• Metabolic Diseases

Locations

Country	Name	City	State
Turkey	Ankara University, Faculty of medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
büsra baspinar

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ]	90 days
Primary	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.	90 days
Primary	Oral glucose tolerance test	The glucose values given in mmol/l after 30', 60', 90' and 120 minutes during OGTT.	14 days
Primary	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	14 days
Primary	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	14 days
Primary	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	14 days
Primary	Weight in kilograms	Children's growth and development will be evaluated according to WHO's percentile scores.	30 days
Primary	Height in meters	Children's growth and development will be evaluated according to WHO's percentile scores.	30 days
Primary	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).	3 days
Primary	Serum C-reactive protein (CRP)	Participants' serum C-reactive protein (CRP) levels will be determined.	14 days
Primary	Serum malondialdehyde (MDA)	Participants' serum malondialdehyde (MDA) levels will be determined.	14 days
Primary	Serum Interleukin-1-beta (IL-1B)	Participants' serum Interleukin-1-beta (IL-1B) levels will be determined.	14 days
Primary	Serum tumor necrosis factor-alpha (TNF-a)	Participants' serum tumor necrosis factor-alpha (TNF-a) levels will be determined.	14 days
Primary	Serum interleukin-6 (IL-6)	Participants' serum interleukin-6 (IL-6) levels will be determined.	14 days
Primary	Serum interferon-gamma	Participants' serum interferon-gamma levels will be determined.	14 days