Skip to main content
OpenTrials
Completed

NCT Number: NCT05200910

The Effect of Transcatheter VSD Closure on Children's Appetite, Hormones and Growth

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ventricular Septal Defect Anorexia Appetite Loss Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Growth Delay Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

3 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Süleyman Sunkak

Kayseri, Kocasinan, 38030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pediatric patients who underwent transcatheter VSD closure

Exclusion criteria

  • Chromosomal abnormalities
  • Additional systemic disease
  • Systemic infections

Treatment and study plan

Primary outcomes

  1. Weight Z score

    Time frame: 6 months

    The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD

  2. Height Z score

    Time frame: 6 month

    The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD

  3. Body mass index Z score

    Time frame: 6 month

    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

  4. Ghrelin

    Time frame: 6 month

    Change in serum ghrelin level of patients after interventional closure of VSD

  5. Leptin

    Time frame: 6 month

    Change in serum leptin level of patients after interventional closure of VSD

  6. Visual analogue scale

    Time frame: 6 month

    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.

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Registry information

Official study title

Nutritional, Hormonal and Anthropometric Evaluation of Children After Transcatheter VSD Closure

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 21, 2022
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.