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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05232695
Other study ID # Batokines-09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date February 1, 2023

Study information

Verified date May 2023
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There are two types of adipose tissue in humans, white and brown adipose tissue. While the main task of white adipose tissue is energy storage, the main task of brown adipose tissue is energy expenditure. It was previously thought that only infants have brown adipose tissue, however today it is known that metabolically active brown adipose tissue exists in adult humans as well. Brown adipose tissue contributes to metabolic health through both energy expenditure and the cytokines they secrete. Although obesity is frequently associated with many metabolic dysfunctions and cardiometabolic diseases such as insulin resistance, prediabetes, atherogenic dyslipidemia, metabolic syndrome, some obese individuals have been defined as metabolically healthy obese. The mechanisms underlying the formation of the metabolic healthy obese phenotype are not well understood. In experimental animal studies, it has been suggested that the molecular phenotype of adipose tissue is an important factor affecting metabolic health in obese individuals. One of the most important factors affecting the molecular phenotype of adipose tissue is the browning potential of adipose tissue. Based on this hypothesis, in this study it is aimed to investigate whether the browning of white adipose tissue has an effect on determining the metabolic phenotype of metabolically healthy and unhealthy obese individuals with the same amount of adipose tissue. It is known that irisin, FGF21 and NRG4 are hormones that have the ability to brown the white adipose tissue. In our study, it was aimed to investigate whether there is a difference in serum FGF21, irisin and Neuregulin4 (NRG4) levels, which have brown adipose tissue browning potential, in metabolically healthy and unhealthy obese. In this way, it will be found out whether serum FGF21, irisin and NRG4 hormones, which have a browning effect on white adipose tissue, have an effect on the metabolic health of obese individuals and whether these hormones can be a treatment target. In this project, participants who have BMI ≥30 kg/m2 and no criteria other than metabolic syndrome criteria, except increased waist circumference (blood pressure ≥130/85 mmHg, fasting blood glucose ≥100 mg/dl, triglyceride ≥150 mg/dl, HDL <40mg/dl in men, <50 mg/dl in women) and those without prediabetes will be defined as metabolically healthy obese, on the other hand other obese individuals will be defined as metabolic unhealthy. 10 ml blood samples will be taken from at least 60 metabolically healthy and 60 metabolically unhealthy participants. Serum FGF21, irisin and NRG4 levels will be measured and their levels in metabolically healthy and unhealthy obese individuals will be compared.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date February 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Body mass index =30 - Body fat percentage =30% in women, =25% in men Exclusion Criteria: - antidiabetic medication usage - antihypetrensive mediaction usage - lipid lowering medication usage - pregancy - hypo/hyperthyroidism - steroid usage - benign/ malign tumor diagnosis - liver disease - secondary causes of obesity

Study Design


Intervention

Diagnostic Test:
metabolically healthy obese
Obese individuals will be divided into 2 groups as metabolic healthy and unhealthy obese, and their batokine concentrations will be compared.

Locations

Country Name City State
Turkey Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

White JD, Dewal RS, Stanford KI. The beneficial effects of brown adipose tissue transplantation. Mol Aspects Med. 2019 Aug;68:74-81. doi: 10.1016/j.mam.2019.06.004. Epub 2019 Jun 21. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Specific batokine concentrations in metabolically healthy end unhealthy obese individuals. The participants' irisin, FGF-21 and NRG-4 levels will be measured to compare their concentrations in metabolically healthy and unhealthy obese individuals. 1 year
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