Effect of Body Composition on Thyroid Hormone Levels Among Overweight and Obese Subjects (3/2020)

March 27, 2020 updated by: Gianluigi Giannelli, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
The study was aimed at investigating the relationship between body composition and thyroid hormone levels in overweight and obese subjects (BMI≥25 Kg/m2)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • BA
      • Bari, BA, Italy, 70123
        • Roberta Zupo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
observational
Observational

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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