Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
90 participants
OBSERVATIONAL
2016-06-03
2017-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Irisin, a myokine, first described by Boström et al. (5) in 2012, is released into the circulation as a product of Fibronectin type III domain-containing 5 (FNDC5) gene activated by increased expression of peroxisome proliferator-activated receptor-ɣ coactivator-1' (PGC1)-α in the muscle cell along with exercise. The circulating irisin increases the expression of UCP1 mRNA in WAT cells. As a result, WAT cells are converted into BAT cells. Thus, irisin is involved in termogenesis and energy consumption.
Conflicting results have been reported in studies investigating the relationship between irisin level and obesity and related complications. Irisin was thought to play a role in the development of obesity. It has been suggested that it may be an alternative treatment agent for obesity and glucose tolerance. In some studies, irisin levels were found to be higher in obese children and adults than in healthy controls, low in some, and not different in others.
There is limited data in the relevant literature about the relationships between childhood obesity and irisin, as well as between NAFLD and irisin. In our study, we aimed to determine whether serum irisin levels are related to anthropometric measurements and metabolic and biochemical parameters in obese children with and without NAFLD.
Sixty obese pubertal patients (31 girls, 29 boys), aged between 11-18 years, admitted to the pediatric endocrinology outpatient clinic of our hospital wiil be included in the study. These patients will be divided into two groups with and without NAFLD. Patients with another disease or any drug use will be not included in the study. The control group consisted of 28 healthy children (14 girls, 14 boys) who will be similar in age and sex to the obese group.
Physical examination will be done in all children. Body weight (BW) and height will be measured. Body mass index (BMI) values will be compared with BMI curves according to age and gender. BMI≥95.p will be considered as obese. Subcutaneous fat thickness will be measured from the triceps and biceps regions by using a caliper. Waist circumference will be measured in the horizontal plane midway between lowest rib and the iliac crest. Hip circumference will be measured over the widest area of the hips. Waist-to-hip ratio will be calculated.
After one night fasting, two venous serum samples will be taken for irisin levels and biochemical analysis. Glucose, total cholesterol (TC), triglycerides (TG), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), ALT, AST, GGT levels, insulin levels will be determined.
Venous serum samples for the irisin levels will be stored at -80°C until the analysis. Serum irisin levels will be measured.
The homeostasis model assessment of insulin resistance (HOMA-IR) will be calculated using the following formula: fasting insulin level (uIU/ml) x fasting glucose (mg/dl) / 405. A HOMA-IR value \>5.22 in males and \>3.82 in females will be considered having IR.
Hepatobiliary ultrasound (US) will performed for NAFLD
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
obese patient with non-alcoholic fatty liver disease
blood sample
obese patient without non-alcoholic fatty liver disease
blood sample
control group
blood sample
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
blood sample
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Puberty
* The control group will be similar in age and sex to the obese group.
Exclusion Criteria
* autoimmune hepatitis,
* primary sclerosing cholangitis,
* hemochromatosis,
* drug-induced liver disease,
* Wilson disease,
* α-1 antitrypsin deficiency,
* type 1 DM,
* pancreatitis,
* thyroid disease,
* renal failure,
* estrogen, progesterone, glucocorticoids, insulin, UDCA, iron, interferon, antibiotics, levothyroxine sodium, metformin, antiepileptic drug used
11 Years
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eskisehir Osmangazi University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
gökçen ulualan
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Eskişehir Osmangazi University Faculty of Medicine
Eskişehir, Eyalet/Yerleşke, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I-OBESITY
Identifier Type: -
Identifier Source: org_study_id