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

NCT ID: NCT04327375

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-01

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.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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observational

observational

Observational

Intervention Type OTHER

Observational

Interventions

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Observational

Observational

Intervention Type OTHER

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

OTHER

Sponsor Role lead

Responsible Party

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Gianluigi Giannelli

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Roberta Zupo

Bari, BA, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 33117281 (View on PubMed)

Other Identifiers

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3/2020

Identifier Type: -

Identifier Source: org_study_id