Celiac Disease Clinical Trial
Official title:
Colyak Hastaliginin Puberte ve Sonrasinda Over Fonksiyonlarina Etkisinin Arastirilmasi
This case-control multicentre trial was performed from January 1, 2017, to May 31, 2018, in University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital and Hitit University Hospital. Adolescents who were in compliance with the inclusion criteria were called by telephone for blood collection and ultrasound on the 3rd day of menstruation after approval from local ethical registration. On days 2-5 of the menstrual cycle, level of follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), prolactin (PRL), and AMH were measured from venous blood samples in both groups. Antral Follicle Counts (AFCs) and ovarian volumes were determined on the same day.
This case-control multicentre trial was performed from January 1, 2017, to May 31, 2018, in
University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital and
Hitit University Hospital. This study was conducted with approval from the BTRH ethical board
(number: 2018/166). This study covered 20 cases suffered from Celiac Disease and 18 were with
regular menstrual period and healthy adolescent girls. Adolescents who were in compliance
with the inclusion criteria were called by telephone for blood collection and ultrasound on
the 3rd day of menstruation after approval from local ethical registration. Data on age, body
mass index (BMI), levels of antitransglutaminase immune globulins A (IgA), positivity to
antiendomysium IgA were recorded. On days 2-5 of the menstrual cycle, level of follicle
stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), prolactin (PRL), and AMH
were measured from venous blood samples in both groups. The samples were centrifuged at 3,000
rpm for 10 minutes to aliquot the supernatants. Antral Follicle Counts (AFCs) and ovarian
volumes were determined on the same day by the same ultrasound devices. The inclusion
criteria included the following items;
- 13 ≤ Age ≤20
- At least one year after menarche
- Non-obesity or malnutrition, Non-Hyperandogenism symptoms, and blood tests, Non-Hyper or
hypothyroidism, Non-Hyperprolactinemia.
- Control group; with a normal menstrual period, Non-chronic diseases The study had
exclusion criteria such as delayed menarche, early puberty, delayed puberty, delayed
development of secondary sexual characters due to another sexual disorder.
IBM SPSS version 22.0 (IBM Corp., Armonk, NY, USA) was used for all data analyses.
Descriptive statistics are presented as numbers and percentages (%) for qualitative variables
and as mean ± standard deviation and median (range) for quantitative variables. Normality
distribution of data was evaluated using Kolmogorov-Smirnov, and Shapiro-Wilk tests to guide
statistical test choice.
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