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Completed

NCT Number: NCT05232695

Brown Fat Tissue Related Hormone Levels in Metabolically Healthy and Unhealthy Obese Individuals

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcın City Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metabolically healthy obese

Diagnostic Test

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

Other names: metabolically unhealthy obese

Primary outcomes

  1. Specific batokine concentrations in metabolically healthy end unhealthy obese individuals.

    Time frame: 1 year

    The participants' irisin, FGF-21 and NRG-4 levels will be measured to compare their concentrations in metabolically healthy and unhealthy obese individuals.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

Comparison of Brown Fat Tissue-related Hormone Levels in Metabolically Healthy and Unhealthy Obese Individuals

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 10, 2022
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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