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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05200910
Other study ID # 7645
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 16, 2018
Est. completion date January 1, 2020

Study information

Verified date January 2022
Source Kayseri City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study; Changes in appetite, hormones and growth of ventricular septal defect patients treated with non-surgical method were evaluated.


Description:

The study included 20 patients whose ventricular septal defect closed percutaneously and 26 children as control group. The symptoms, anthropometric measurements and laboratory tests of patient group were recorded at initial, 1st month and 6th months after closure. Anthropometric measurements; weight for age (WFA), height for age (HFA), body mass index (BMI) and their z scores, triceps skinfold thickness (TSF) and mid-upper arm circumference (MUAC) were recorded on admission. Patients with weight for height z score less than -2 were defined as malnutrition. Questions about the symptoms like appetite, weight gain, frequency of illness, rate of breathing, fatigue were asked to all parents at initial. These questionnaires15 and visual analogue scale (for appetite) were repeated at 1st and 6th month visits. During the initial evaluation, approximately 6 ml of venous blood samples were taken between 9:00-10:00 am after an average of 10 hours fasting. On the same day, IGFBP-3, Ghrelin and leptin,fasting blood glucose, insulin, IGF-1, IGFBP-3, aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total protein, and albumin were measured. Anthropometric measurements and laboratory tests were repeated at 1st and 6th month visits.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date January 1, 2020
Est. primary completion date June 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Months to 18 Years
Eligibility Inclusion Criteria: Pediatric patients who underwent transcatheter VSD closure Exclusion Criteria: - Chromosomal abnormalities - Additional systemic disease - Systemic infections

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Süleyman Sunkak Kayseri Kocasinan

Sponsors (1)

Lead Sponsor Collaborator
Kayseri City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight Z score The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD 6 months
Primary Height Z score The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD 6 month
Primary Body mass index Z score The change in the Z scores of the body mass index according to the age of the patients after the interventional closure of the VSD 6 month
Primary Ghrelin Change in serum ghrelin level of patients after interventional closure of VSD 6 month
Primary Leptin Change in serum leptin level of patients after interventional closure of VSD 6 month
Primary Visual analogue scale Change in Visual analogue scale of patients and parent after interventional closure of VSD. Values in this scale vary between 0-100 mm, values close to '0' are composed of words and images expressing a decrease in the patient's appetite, values close to '100' representing an increase in appetite. 6 month
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