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Relationship Between Skeletal Muscle Mass and Interventricular Septum Thickness in Apparently Healthy Overweight and Obese Subjects

Relationship Between Skeletal Muscle Mass and Interventricular Septum Thickness in Apparently Healthy Overweight and Obese Subjects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04264091
Enrollment
120
Registered
2020-02-11
Start date
2019-01-01
Completion date
2019-11-01
Last updated
2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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.

Interventions

OTHERObservational

Observational

Sponsors

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
interventricular septum thicknessBaselineinterventricular septum thickness (mm)
skeletal muscle massBaselineskeletal muscle mass (kg)

Secondary

MeasureTime frameDescription
eGFR (estimated glomerular filtration rate)BaselineeGFR (ml/min/1.73 mq)
CreatininBaselineCreatinin (mg/dl) concentration in serum
Total cholesterolBaselineTotal cholesterol (mg/dL) concentrations in serum
Thyroid hormones (FT3, FT4)BaselineFT3 (pg/mL), FT4 (pg/mL) concentration in serum
HDL cholesterolBaselineHDL cholesterol (mg/dL) concentrations in serum
Vitamin DBaselineVitamin D (ng/mL) concentration in serum
TSHBaselineTSH (mU/L) concentration in serum
BMIBaselineBMI (kg/m\^2)
HeightBaselineHeight in meters
WeightBaselineWeight in kilograms
LDL cholesterolBaselineLDL cholesterol (mg/dL) concentrations in serum
InsulinBaselineInsulin (mIU/L) concentration in serum

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026