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

NCT ID: NCT05748444

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-08-01

Brief Summary

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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

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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

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Cystic Fibrosis Glucose Metabolism Disorders

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Children with cystic fibrosis

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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büşra başpınar

OTHER

Sponsor Role lead

Responsible Party

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büşra başpınar

Busra Baspinar

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ankara University, Faculty of medicine

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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büşra başpınar

Role: primary

+905534375414

Other Identifiers

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busrabasp92

Identifier Type: -

Identifier Source: org_study_id

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