Follistatin Levels in Metabolically Healthy and Unhealthy Obese Individuals

NCT06229899 | Completed

• 1 other identifier: Metabolic health-Follistatin
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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

Serum follistatin levels DIAGNOSTIC_TEST

blood samples are taken

metabolically healthy individuals with obesity; metabolically unhealthy individuals with obesity

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Goztepe Prof Dr Suleyman Yalcın City Hospital: lead

Study Sites (1)

Istanbul Medeniyet University Goztepe Research and TRaining Hospital

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples for follistatin

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşe N Erbakan, MD

  Istanbul Medeniyet University Goztepe Research and TRaining Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 29, 2024
• Study Start: January 15, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

TU (1)