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Completed

NCT Number: NCT04327375

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

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

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Roberta Zupo

Bari, BA, 70123, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

Observational

Primary outcomes

  1. Thyroid hormones (FT3, FT4)

    Time frame: Baseline

    FT3 (pg/mL), FT4 (pg/mL) concentration in serum

  2. skeletal muscle mass

    Time frame: Baseline

    skeletal muscle mass (kg)

  3. TSH

    Time frame: At baseline

    TSH (mU/L) concentration in serum

Secondary outcomes

  1. Vitamin D

    Time frame: Baseline

    Vitamin D (ng/mL) concentration in serum

  2. Insulin

    Time frame: Baseline

    Insulin (mIU/L) concentration in serum

  3. eGFR (estimated glomerular filtration rate)

    Time frame: Baseline

    eGFR (ml/min/1.73 mq)

  4. Creatinin

    Time frame: Baseline

    Creatinin (mg/dl) concentration in serum

  5. Total cholesterol

    Time frame: Baseline

    Total cholesterol (mg/dL) concentrations in serum

  6. HDL cholesterol

    Time frame: Baseline

    HDL cholesterol (mg/dL) concentrations in serum

  7. LDL cholesterol

    Time frame: Baseline

    LDL cholesterol (mg/dL) concentrations in serum

  8. BMI

    Time frame: Baseline

    BMI (kg/m^2)

  9. Height

    Time frame: Baseline

    Height in meters

  10. Weight

    Time frame: Baseline

    Weight in kilograms

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Other

Registry information

Acronym: 3/2020

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 31, 2020
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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