Effect of Body Composition on Thyroid Hormone Levels Amon... | NCT04327375

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

NCT04327375

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Status

Completed

Last Update Posted

Mar 31, 2020Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Obesity

Interventions

Observational

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Dec 1, 2019Actual

First Submitted Date

Mar 27, 2020

First Submission Date that Met QC Criteria

Mar 27, 2020

First Posted Date

Mar 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2020

Last Update Posted Date

Mar 31, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gianluigi Giannelli, Clinical Professor, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
observational		observational	Other: Observational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	Observational	observational

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Vitamin D	Vitamin D (ng/mL) concentration in serum	Baseline
Insulin	Insulin (mIU/L) concentration in serum	Baseline

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Roberta Zupo		Bari	BA	70123	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33117281	Derived	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.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration