NCT04524936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

10 months

First QC Date

August 19, 2020

Last Update Submit

August 27, 2020

Conditions

Keywords

irisinobesitychildrennon-alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (1)

  • serum irisin levels

    Serum irisin levels were measured and compared in three groups

    1 day

Study Arms (3)

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

Interventions

blood sampleDIAGNOSTIC_TEST
control groupobese patient with non-alcoholic fatty liver diseaseobese patient without non-alcoholic fatty liver disease

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

pubertal children

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Osmangazi University Faculty of Medicine

Eskişehir, Eyalet/Yerleşke, 11111, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityNon-alcoholic Fatty Liver Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 24, 2020

Study Start

June 3, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

August 31, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations