Effect of Body Composition on Thyroid Hormone Levels Among Overweight and Obese Subjects
3/2020
1 other identifier
observational
250
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 31, 2020
CompletedMarch 31, 2020
March 1, 2020
11 months
March 27, 2020
March 27, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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 (10)
Vitamin D
Baseline
Insulin
Baseline
eGFR (estimated glomerular filtration rate)
Baseline
Creatinin
Baseline
Total cholesterol
Baseline
- +5 more secondary outcomes
Study Arms (1)
observational
observational
Interventions
Eligibility Criteria
Patients who came to the Outpatient Clinic of Nutrition at the National Institute of Gastroenterology "S. de Bellis," Research Hospital, Castellana Grotte, Italy.
You may qualify if:
- Overweight or obesity (BMI\> 25 Kg/m2)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roberta Zupo
Bari, BA, 70123, Italy
Related Publications (1)
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.
PMID: 33117281DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
March 27, 2020
First Posted
March 31, 2020
Study Start
January 1, 2019
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
March 31, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share