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CompletedNCT06229899Updated Jan 30, 2024

Follistatin Levels in Metabolically Healthy and Unhealthy Obese Individuals

An observational study in Obesity, sponsored by Goztepe Prof Dr Suleyman Yalcın City Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by Goztepe Prof Dr Suleyman Yalcın City Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
62
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Obesity
03

In context

Lead sponsor

Goztepe Prof Dr Suleyman Yalcın City Hospital is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Individuals between 18-60 years old, with a BMI of ≥ 30, who are not using any medication or have any disease that may effect their glycemia, lipid profiles or blood pressure.

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
62 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • metabolically healthy individuals with obesity

    Individuals with BMI ≥30 , 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

    Diagnostic Test: Serum follistatin levels

  • metabolically unhealthy individuals with obesity

    Individuals with BMI ≥30 , and have one of the followings: 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

    Diagnostic Test: Serum follistatin levels

Interventions

  • Diagnostic testSerum follistatin levels

    blood samples are taken

06

What researchers measure

Primary outcomes

  1. relation between follistatin and metabolically healthy and unhealthy obesity

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

    Time frame: baseline

  2. threshold for follistatin in metabolic evaluation of obesity

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

    Time frame: baseline

07

Study locations

1 site
  • Istanbul Medeniyet University Goztepe Research and TRaining Hospital
    Istanbul, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06229899
Lead sponsor
Goztepe Prof Dr Suleyman Yalcın City Hospital
Responsible party
Ayse N Erbakan (Principal investigator, Goztepe Prof Dr Suleyman Yalcın City Hospital) — Principal investigator
First posted
Jan 29, 2024
Start date
Jan 15, 2022
Primary completion
Jan 15, 2023
Completion
Jan 15, 2023
Last update
Jan 30, 2024

Study contacts

Ayşe N Erbakan, MD
principal investigator · Istanbul Medeniyet University Goztepe Research and TRaining Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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