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

NCT05748444 | Unknown

• 1 other identifier: busrabasp92
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Glucose Metabolism Disorders

Keywords

Inflammation; Cystic fibrosis; Glycemic response; Diet; Glycemic index; Blood glucose excursion; Inflammatory markers

Outcome Measures

Primary Outcomes (15)

• 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

• 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

• Oral glucose tolerance test

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

  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

  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

  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

  14 days

• Weight in kilograms

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

  30 days

• Height in meters

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

  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).

  3 days

• Serum C-reactive protein (CRP)

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

  14 days

• Serum malondialdehyde (MDA)

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

  14 days

• Serum Interleukin-1-beta (IL-1B)

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

  14 days

• Serum tumor necrosis factor-alpha (TNF-a)

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

  14 days

• Serum interleukin-6 (IL-6)

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

  14 days

• Serum interferon-gamma

  Participants' serum interferon-gamma levels will be determined.

  14 days

Study Arms (1)

Children with cystic fibrosis

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

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• büşra başpınar: lead

Study Sites (1)

Ankara University, Faculty of medicine

Ankara, 06080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Glucose Metabolism Disorders; Inflammation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Busra Baspinar

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 28, 2023
• Study Start: January 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

TU (1)