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Serum Irisin Levels in Obese Children

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ClinicalTrials.gov Identifier: NCT04524936
Recruitment Status : Completed
First Posted : August 24, 2020
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
gökçen ulualan, Eskisehir Osmangazi University

Study Description
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Brief Summary:
Irisin is a myokine induced by exercise, that converts white fat tissue to brown fat tissue, thereby increases thermogenesis and energy expenditure. The aim of this study is to determine the relationships between serum irisin levels and glucose and lipid parameters in obese children with and without non-alcoholic fatty liver disease (NAFLD). A total of 60 pubertal obese children (age range: 11-18 years) will be included in the study. 30 of these patients will be had NAFLD. The control group consisted of 28 healthy children who will be similar in age and sex to the obese group.

Condition or disease Intervention/treatment
Serum Irisin Levels in Obese Children Diagnostic Test: blood sample

Detailed Description:

Obesity and related complications (non-alcoholic fatty liver disease (NAFLD), type 2 diabetes mellitus (DM)) have become an important public health problem. Their prevalence continues to increase worldwide in children. Therefore, estimating potential biomarkers that can cause obesity and related complications can be important in their treatment.

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

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Relation of Serum Irisin Levels, Non-Alcoholic Fatty Liver Disease, Glucose and Lipid Metabolism Parameters in Obese Children
Actual Study Start Date : June 3, 2016
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
obese patient with non-alcoholic fatty liver disease Diagnostic Test: blood sample
obese patient without non-alcoholic fatty liver disease Diagnostic Test: blood sample
control group Diagnostic Test: blood sample


Outcome Measures
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Primary Outcome Measures :
  1. serum irisin levels [ Time Frame: 1 day ]
    Serum irisin levels were measured and compared in three groups


Eligibility Criteria
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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
pubertal children
Criteria

Inclusion Criteria:

  • BMI≥95.p
  • Puberty
  • The control group will be similar in age and sex to the obese group.

Exclusion Criteria:

  • viral hepatitis,
  • 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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524936


Locations
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Turkey
Eskişehir Osmangazi University Faculty of Medicine
Eskişehir, Eyalet/Yerleşke, Turkey, 11111
Sponsors and Collaborators
Eskisehir Osmangazi University
More Information
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Responsible Party: gökçen ulualan, Principal Investigator, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier: NCT04524936    
Other Study ID Numbers: I-OBESITY
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by gökçen ulualan, Eskisehir Osmangazi University:
irisin
obesity
children
non-alcoholic fatty liver disease
Additional relevant MeSH terms:
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Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Fatty Liver