Serum Irisin Levels in Obese Children

August 27, 2020 updated by: gökçen ulualan, Eskisehir Osmangazi University

Relation of Serum Irisin Levels, Non-Alcoholic Fatty Liver Disease, Glucose and Lipid Metabolism Parameters in Obese Children

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Eyalet/Yerleşke
      • Eskişehir, Eyalet/Yerleşke, Turkey, 11111
        • Eskisehir Osmangazi University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

pubertal children

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
control group
Diagnostic test: blood sample
obese patient with non-alcoholic fatty liver disease
Diagnostic test: blood sample
obese patient without non-alcoholic fatty liver disease
Diagnostic test: blood sample

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
serum irisin levels
Time Frame: 1 day
Serum irisin levels were measured and compared in three groups
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eskisehir Osmangazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 3, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • I-OBESITY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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