ObesityNCT04264091
Relationship Between Skeletal Muscle Mass and Interventricular Septum Thickness in Apparently Healthy 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 skeletal muscle mass and interventricular septum thickness in overweight and obese subjects (BMI≥25) Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Observational
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 1 Nov 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
- Healthy volunteers accepted
- 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.
Italy1 site
National Institute of Gastroenterology IRCCS S. de Bellis
Castellana Grotte, Bari, 70132
About this study
The study was aimed at investigating the relationship between skeletal muscle mass and interventricular septum thickness in overweight and obese subjects (BMI≥25)
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), echocardiography, 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
What is being measured
The primary outcome is the main question the study is designed to answer.
interventricular septum thickness
interventricular septum thickness (mm)
Measured: Baseline
skeletal muscle mass
skeletal muscle mass (kg)
Measured: Baseline
Secondary outcomes (12)
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
Thyroid hormones (FT3, FT4)
FT3 (pg/mL), FT4 (pg/mL) concentration 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
TSH
TSH (mU/L) concentration 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 posted11 Feb 2020
- Study start1 Jan 2019
- Primary completion1 Oct 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 120 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
- NCT04264091
- Sponsor's protocol ID
- 1/2020
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Skeletal Muscle Mass and Interventricular Septum Thickness in Apparently Healthy Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT04264091
- Acronym / sponsor ID
- 1/2020
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 11 Feb 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 skeletal muscle mass and interventricular septum thickness in overweight and obese subjects (BMI≥25)
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), echocardiography, 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
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- 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 | – |
Primary outcome
interventricular septum thickness
Time frame: Baseline
interventricular septum thickness (mm)
skeletal muscle mass
Time frame: Baseline
skeletal muscle mass (kg)
12 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
Thyroid hormones (FT3, FT4)
Time frame: Baseline
HDL cholesterol
Time frame: Baseline
LDL cholesterol
Time frame: Baseline
TSH
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 12 Feb 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 12 Feb 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?
interventricular septum thickness (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.