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OpenTrials
Completed

NCT Number: NCT06229899

Follistatin Levels in Metabolically Healthy and Unhealthy Obese Individuals

There is no clear boundary on which obese individuals should be considered metabolically healthy and which should be considered metabolically unhealthy. It is also not very clear whether the individuals who are considered metabolically healthy will remain healthy in the future. The objective of this study was to assess potential disparities in serum follistatin levels between these two distinct groups. Furthermore, the study sought to investigate whether this disparity could serve as a reliable indicator for distinguishing between metabolically healthy and unhealthy obese individuals.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medeniyet University Goztepe Research and TRaining Hospital

Istanbul, Turkey (Türkiye)

About this study

Individuals with similar body mass indexes may have different metabolic health and cardiovascular risks. Research shows that some individuals with comparable body mass index (BMI) are metabolically healthy and have a lower risk of cardiovascular issues, while others are metabolically unhealthy and have a higher risk. Studies indicate that the lifestyles of metabolically healthy and unhealthy obese individuals, such as diet, physical activity, and sleep patterns, do not differ significantly, even though the individuals have similar levels of total or subcutaneous adiposity. However, it has been shown that metabolically healthy obese individuals tend to have lower levels of visceral adiposity compared to unhealthy ones.

Patients with BMI≥30, who applied to the internal medicine clinic, were included in the study. Among these patients, those without criteria of metabolic syndrome other than an increase in waist circumference (blood pressure ≥130/85 mmHg, fasting blood sugar ≥100 mg/dl, triglycerides ≥150 mg/dl, HDL-cholesterol <40 mg/dl in men and <50 mg/dl in women) and without prediabetes were defined as metabolically healthy obese individuals. Those with at least 1 metabolic syndrome criterion other than an increase in waist circumference were classified as metabolically unhealthy obese individuals. The participants' fasting blood sugar levels, HbA1c levels, insulin levels, lipid panel results, liver enzymes levels,urea levels, creatinine levels, whole blood count, and thyroid hormones were examined. Anthropometric measurements including height,weight and waist circumference were also taken for each individual.

Participants were then invited back to repeat follistatin levels.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Having given consent to the study
  • Being over 18 years of age
  • Being under 60 years of age
  • Body mass index >=30 kg/m2

Exclusion criteria

  • Antidiabetic medication usage
  • obesity surgery
  • Antihypertensive medication usage
  • Those receiving lipid-lowering therapy
  • Pregnant women
  • Those with hypo/hyperthyroidism
  • Steroid use
  • Benign/malignant tumors
  • Advanced liver disease
  • Secondary causes of obesity

Treatment and study plan

Serum follistatin levels

Diagnostic Test

blood samples are taken

Primary outcomes

  1. relation between follistatin and metabolically healthy and unhealthy obesity

    Time frame: baseline

    This study aims to examine the correlation between follistatin levels and both metabolically healthy and unhealthy individuals with obesity

  2. threshold for follistatin in metabolic evaluation of obesity

    Time frame: baseline

    The establishment of a threshold value for follistatin levels in assessing metabolic health in obese individuals.

Sponsors and collaborators

Lead sponsor

Goztepe Prof Dr Suleyman Yalcın City Hospital

Other

Registry information

Official study title

Can Follistatin Levels Help Distinguish Between Metabolically Healthy and Unhealthy Obese Individuals

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 29, 2024
Registry last updated
Jan 30, 2024

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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