Clinical trial NCT04327375: Effect of Body Composition on Thyroid Hormone Levels Among Overweight and Obese Subjects
Official title: Effect of Body Composition on Thyroid Hormone Levels Among Overweight and Obese Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who came to the Outpatient Clinic of Nutrition at the National Institute of Gastroenterology "S. de Bellis," Research Hospital, Castellana Grotte, Italy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thyroid hormones (FT3, FT4)
timeFrame: Baseline
measure: skeletal muscle mass
timeFrame: Baseline
measure: TSH
timeFrame: At baseline
Secondary outcomes:
measure: Vitamin D
timeFrame: Baseline
measure: Insulin
timeFrame: Baseline
measure: eGFR (estimated glomerular filtration rate)
timeFrame: Baseline
measure: Creatinin
timeFrame: Baseline
measure: Total cholesterol
timeFrame: Baseline
measure: HDL cholesterol
timeFrame: Baseline
measure: LDL cholesterol
timeFrame: Baseline
measure: BMI
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Roberta Zupo
state: BA
Study officials:
References:
citation: Zupo R, Castellana F, Sardone R, Lampignano L, Paradiso S, Giagulli VA, Triggiani V, Di Lorenzo L, Giannelli G, De Pergola G. Higher Muscle Mass Implies Increased Free-Thyroxine to Free-Triiodothyronine Ratio in Subjects With Overweight and Obesity. Front Endocrinol (Lausanne). 2020 Sep 29;11:565065. doi: 10.3389/fendo.2020.565065. eCollection 2020.