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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04327375
Acronym
3/2020
Enrollment
250
Registered
2020-03-31
Start date
2019-01-01
Completion date
2019-12-01
Last updated
2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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

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.

Interventions

OTHERObservational

Observational

Sponsors

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

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

Design outcomes

Primary

MeasureTime frameDescription
TSHAt baselineTSH (mU/L) concentration in serum
Thyroid hormones (FT3, FT4)BaselineFT3 (pg/mL), FT4 (pg/mL) concentration in serum
skeletal muscle massBaselineskeletal muscle mass (kg)

Secondary

MeasureTime frameDescription
Total cholesterolBaselineTotal cholesterol (mg/dL) concentrations in serum
HDL cholesterolBaselineHDL cholesterol (mg/dL) concentrations in serum
BMIBaselineBMI (kg/m\^2)
Vitamin DBaselineVitamin D (ng/mL) concentration in serum
InsulinBaselineInsulin (mIU/L) concentration in serum
eGFR (estimated glomerular filtration rate)BaselineeGFR (ml/min/1.73 mq)
CreatininBaselineCreatinin (mg/dl) concentration in serum
LDL cholesterolBaselineLDL cholesterol (mg/dL) concentrations in serum
HeightBaselineHeight in meters
WeightBaselineWeight in kilograms

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026