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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264091
• Other study ID #: 1/2020
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: February 2020
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Observational
Observational

Locations

Country	Name	City	State
Italy	National Institute of Gastroenterology IRCCS S. de Bellis	Castellana Grotte	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interventricular septum thickness	interventricular septum thickness (mm)	Baseline
Primary	skeletal muscle mass	skeletal muscle mass (kg)	Baseline
Secondary	Vitamin D	Vitamin D (ng/mL) concentration in serum	Baseline
Secondary	Insulin	Insulin (mIU/L) concentration in serum	Baseline
Secondary	eGFR (estimated glomerular filtration rate)	eGFR (ml/min/1.73 mq)	Baseline
Secondary	Creatinin	Creatinin (mg/dl) concentration in serum	Baseline
Secondary	Total cholesterol	Total cholesterol (mg/dL) concentrations in serum	Baseline
Secondary	Thyroid hormones (FT3, FT4)	FT3 (pg/mL), FT4 (pg/mL) concentration in serum	Baseline
Secondary	HDL cholesterol	HDL cholesterol (mg/dL) concentrations in serum	Baseline
Secondary	LDL cholesterol	LDL cholesterol (mg/dL) concentrations in serum	Baseline
Secondary	TSH	TSH (mU/L) concentration in serum	Baseline
Secondary	BMI	BMI (kg/m^2)	Baseline
Secondary	Height	Height in meters	Baseline
Secondary	Weight	Weight in kilograms	Baseline