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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06229899
Other study ID # Metabolic health-Follistatin
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2022
Est. completion date January 15, 2023

Study information

Verified date January 2024
Source Goztepe Prof Dr Suleyman Yalcin City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date January 15, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Serum follistatin levels
blood samples are taken

Locations

Country Name City State
Turkey Istanbul Medeniyet University Goztepe Research and TRaining Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Goztepe Prof Dr Suleyman Yalcin City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 baseline
Primary threshold for follistatin in metabolic evaluation of obesity The establishment of a threshold value for follistatin levels in assessing metabolic health in obese individuals. baseline
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