Clinical trial NCT06229899: Follistatin Levels in Metabolically Healthy and Unhealthy Obese Individuals
Official title: Can Follistatin Levels Help Distinguish Between Metabolically Healthy and Unhealthy Obese Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: relation between follistatin and metabolically healthy and unhealthy obesity
timeFrame: baseline
measure: threshold for follistatin in metabolic evaluation of obesity
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Goztepe Research and TRaining Hospital
Study officials:
affiliation: Istanbul Medeniyet University Goztepe Research and TRaining Hospital
name: Ayşe N Erbakan, MD
role: PRINCIPAL_INVESTIGATOR
References: