Serum Irisin Levels in Obese ChildrenNCT04524936
Serum Irisin Levels in Obese Children
An observational study of Serum Irisin Levels in Obese Children, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Serum Irisin Levels in Obese Children
- What is being tested?
- blood sample
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2016to 1 Apr 2017
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: pubertal children
Who may be able to join
- BMI≥95.p
- Puberty
- The control group will be similar in age and sex to the obese group.
Who cannot join
- viral hepatitis,
- autoimmune hepatitis,
- primary sclerosing cholangitis,
- hemochromatosis,
- drug-induced liver disease,
- Wilson disease,
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University Faculty of Medicine
Eskişehir, Eyalet/Yerleşke, 11111
About this study
Official title: 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.
Read the 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
- Conditions
- Serum Irisin Levels in Obese Children
- Being tested
- blood sample
- Keywords
- irisin, obesity, children, non-alcoholic fatty liver disease
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| obese patient with non-alcoholic fatty liver disease | Not described Receives: Diagnostic Test: blood sample | |
| obese patient without non-alcoholic fatty liver disease | Not described Receives: Diagnostic Test: blood sample | |
| control group | Not described Receives: Diagnostic Test: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum irisin levels
Serum irisin levels were measured and compared in three groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start3 Jun 2016
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serum Irisin Levels in Obese ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gökçen ulualan, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524936
- Sponsor's protocol ID
- I-OBESITY
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Serum Irisin Levels, Non-Alcoholic Fatty Liver Disease, Glucose and Lipid Metabolism Parameters in Obese Children
- ClinicalTrials.gov ID
- NCT04524936
- Acronym / sponsor ID
- I-OBESITY
- Conditions
- Serum Irisin Levels in Obese Children
- Keywords
- irisin, obesity, children, non-alcoholic fatty liver disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 3 Jun 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- pubertal children
Key inclusion criteria (3 listed)
- BMI≥95.p
- Puberty
- The control group will be similar in age and sex to the obese group.
Key exclusion criteria (12 listed)
- viral hepatitis,
- autoimmune hepatitis,
- primary sclerosing cholangitis,
- hemochromatosis,
- drug-induced liver disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample | Diagnostic test | control group, obese patient with non-alcoholic fatty liver disease, obese patient without non-alcoholic fatty liver disease |
Primary outcome
serum irisin levels
Time frame: 1 day
Serum irisin levels were measured and compared in three groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serum Irisin Levels in Obese Children, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum irisin levels (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.