Obesity3/2020NCT04327375
Effect of Body Composition on Thyroid Hormone Levels Among Overweight and Obese Subjects
An observational study of Obesity, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial 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) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity
- What is being tested?
- Observational
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older 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.
Who may be able to join
- Overweight or obesity (BMI> 25 Kg/m2)
Who cannot join
- Any kind of drug
- Hypertension
- Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
- Chronic inflammatory diseases
- Renal failure
- Liver failure
Show all 10Show fewer
- Angina pectoris
- Myocardial infarction and heart failure
- Genetic heart diseases
- Thrombocytopenias
Trial locations and contacts
1 site in 1 country.
About this study
The study was aimed at investigating the relationship between body composition and thyroid hormone levels in overweight and obese subjects (BMI≥25 Kg/m2)
Read the 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.
- Conditions
- Obesity
- Being tested
- Observational
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| observational | observational Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid hormones (FT3, FT4)
FT3 (pg/mL), FT4 (pg/mL) concentration in serum
Measured: Baseline
skeletal muscle mass
skeletal muscle mass (kg)
Measured: Baseline
TSH
TSH (mU/L) concentration in serum
Measured: At baseline
Secondary outcomes (10)
Vitamin D
Vitamin D (ng/mL) concentration in serum
Measured: Baseline
Insulin
Insulin (mIU/L) concentration in serum
Measured: Baseline
eGFR (estimated glomerular filtration rate)
eGFR (ml/min/1.73 mq)
Measured: Baseline
Creatinin
Creatinin (mg/dl) concentration in serum
Measured: Baseline
Total cholesterol
Total cholesterol (mg/dL) concentrations in serum
Measured: Baseline
HDL cholesterol
HDL cholesterol (mg/dL) concentrations in serum
Measured: Baseline
LDL cholesterol
LDL cholesterol (mg/dL) concentrations in serum
Measured: Baseline
BMI
BMI (kg/m^2)
Measured: Baseline
Height
Height in meters
Measured: Baseline
Weight
Weight in kilograms
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Jan 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluigi Giannelli, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327375
- Sponsor's protocol ID
- 3/2020
- Acronym
- 3/2020
- Status last verified
- Mar 2020
- First submitted
- 27 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33117281
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Body Composition on Thyroid Hormone Levels Among Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT04327375
- Acronym / sponsor ID
- 3/2020 / 3/2020
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational | – | Other: Observationalobservational |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- Overweight or obesity (BMI> 25 Kg/m2)
Key exclusion criteria (10 listed)
- Any kind of drug
- Hypertension
- Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
- Chronic inflammatory diseases
- Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | observational |
Primary outcome
Thyroid hormones (FT3, FT4)
Time frame: Baseline
FT3 (pg/mL), FT4 (pg/mL) concentration in serum
skeletal muscle mass
Time frame: Baseline
skeletal muscle mass (kg)
TSH
Time frame: At baseline
TSH (mU/L) concentration in serum
10 secondary outcomes
Vitamin D
Time frame: Baseline
Insulin
Time frame: Baseline
eGFR (estimated glomerular filtration rate)
Time frame: Baseline
Creatinin
Time frame: Baseline
Total cholesterol
Time frame: Baseline
HDL cholesterol
Time frame: Baseline
LDL cholesterol
Time frame: Baseline
BMI
Time frame: Baseline
Height
Time frame: Baseline
Weight
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Derived from this study: PubMed 33117281Zupo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid hormones (FT3, FT4) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04327375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.