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Clinical Trials/NCT04264091
NCT04264091
Completed
Not Applicable

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

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis1 site in 1 country120 target enrollmentJanuary 1, 2019
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Enrollment
120
Locations
1
Primary Endpoint
interventricular septum thickness
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
November 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Responsible Party
Principal Investigator
Principal Investigator

Gianluigi Giannelli

Clinical Professor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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

Outcomes

Primary Outcomes

interventricular septum thickness

Time Frame: Baseline

interventricular septum thickness (mm)

skeletal muscle mass

Time Frame: Baseline

skeletal muscle mass (kg)

Secondary Outcomes

  • Creatinin(Baseline)
  • Vitamin D(Baseline)
  • Insulin(Baseline)
  • eGFR (estimated glomerular filtration rate)(Baseline)
  • Thyroid hormones (FT3, FT4)(Baseline)
  • HDL cholesterol(Baseline)
  • LDL cholesterol(Baseline)
  • TSH(Baseline)
  • BMI(Baseline)
  • Weight(Baseline)
  • Total cholesterol(Baseline)
  • Height(Baseline)

Study Sites (1)

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