Effect of Body Composition on Thyroid Hormone Levels Among Overweight and Obese Subjects

Study Overview
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Brief Summary
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The study was aimed at investigating the relationship between body composition and thyroid hormone levels in overweight and obese subjects (BMI≥25 Kg/m2)

Detailed Description
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Subjects were enrolled at the first examination whether they were not taking any medication, including oral contraceptives or drugs for osteoporosis, and free of significant medical illnesses, except obesity. Exclusion criteria were history of endocrinological diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), chronic inflammatory diseases, stable known hypertension, angina pectoris, stroke, transient ischemic attack, heart infarction, congenital heart disease, malignancies, chronic inflammatory diseases, renal and liver failure, angina pectoris, myocardial infarction, heart failure, congenital heart diseases, minor and major stroke, and inherited thrombocytopenias and other major malignancies. Subjects were examined by means of the medical history, hormonal, metabolic and routine hematochemical parameters. The investigators provided for a clinical baseline evaluation that included extemporaneous ambulatory blood pressure (BP), bioimpedance and a physical assessment of body weight, Body Mass Index (BMI) and Waist Circumference (WC) as anthropometric parameters.

Official Title
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Effect of Body Composition on Thyroid Hormone Levels Among Overweight and Obese Subjects

Conditions
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Obesity

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight or obesity (BMI> 25 Kg/m2) Exclusion Criteria: Any kind of drug Hypertension Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), Chronic inflammatory diseases Renal failure Liver failure Angina pectoris Myocardial infarction and heart failure Genetic heart diseases Thrombocytopenias
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observational<br>observational | Other: Observational<br>* Observational<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroid hormones (FT3, FT4) | FT3 (pg/mL), FT4 (pg/mL) concentration in serum | Baseline | 
| skeletal muscle mass | skeletal muscle mass (kg) | Baseline | 
| TSH | TSH (mU/L) concentration in serum | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D | Vitamin D (ng/mL) concentration in serum | Baseline | 
| Insulin | Insulin (mIU/L) concentration in serum | Baseline | 
| eGFR (estimated glomerular filtration rate) | eGFR (ml/min/1.73 mq) | Baseline | 
| Creatinin | Creatinin (mg/dl) concentration in serum | Baseline | 
| Total cholesterol | Total cholesterol (mg/dL) concentrations in serum | Baseline | 
| HDL cholesterol | HDL cholesterol (mg/dL) concentrations in serum | Baseline | 
| LDL cholesterol | LDL cholesterol (mg/dL) concentrations in serum | Baseline | 
| BMI | BMI (kg/m^2) | Baseline | 
| Height | Height in meters | Baseline | 
| Weight | Weight in kilograms | Baseline |