Clinical trial NCT05472480: Anthropometric and Psychosocial Measurements in Vascular Disease
Official title: Association Between Anthropometric and Psychosocial Measurements in Vascular Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vascular Diseases
Psychosocial Problem
Social Functioning
Keywords: sociology
vascular disease
anthropometric measurements
Psychosocial
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with vascular diseases (CVD, CS, AAA, PAD) admitted to Vascular Surgery Units of two hospitals linked with Interuniversity Center of Phlebolymphology (CIFL) International Research and Educational Program in Clinical and Experimental Biotechnology (Mater Domini University Hospital of Catanzaro and the Federico II University Hospital of Naples).

Brief summary: This experimental study is to verify a possible correlation between vascular disease, and anthropometric, and psychosocial measurements.

Consecutive patients with vascular diseases (Chronic Venous Disease, Carotid Stenosis, Abdominal Aortic Aneurysm, Peripheral Artery Disease) will be referred to Vascular Surgery Units of two hospitals linked to Interuniversity Center of Phlebolymphology (CIFL) International Research and Educational Program in Clinical and Experimental Biotechnology (Mater Domini University Hospital of Catanzaro and the Federico II University Hospital of Naples) to be evaluated.

Since it is necessary to study the anthropometric measures and the psychosocial aspects, different types of measurements will be carried out in order to correlate them with the aforementioned vascular disease.

Detailed description: This is a cross sectional study with the aim analyze the association between the anthropometric and psychosocial measures in the following vascular disease: Chronic Venous Disease (CVD), Carotid Stenosis (CS) , Abdominal Aortic Aneurysm (AAA) , Peripheral Artery Disease (PAD).

Consecutive patients with vascular diseases (CVD, CS, AAA, PAD) referred to Vascular Surgery Units of two hospitals (Mater Domini University Hospital of Catanzaro and the Federico II University Hospital of Naples) will be evaluated.

Different types of measurements will be evaluated: body mass index (BMI), weight, height, waist circumference, waist / hip ratio (WHR), waist / stature (WSR) and the ABSI "a body" score shape index ". To complete the study, the personal experiences of the patients will be analyzed through the administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ).

The data will be extrapolated from a prospective analysis on patients, by inserting in a Microsoft Excel database: demographic characteristics (age, sex); anthropometric parameters (height, weight, BMI, waist circumference WHR WSR ABSI); comorbidities, with particular reference to Diabetes mellitus, Dyslipidemia, Hypertension, CRI, coronary heart disease; smoking as a risk factor; the questionnaire for psychosocial aspects (BIDQ) on cumulative score (1-15); the vascular disease under examination. Population variables (age) and continuous outcomes (weight, age, BMI, waist circumference, WHR, WSR, ABSI, BIDQ) will be analyzed by Kruskal-Wallis test, while categorical variables (males, smokers, hypertension, diabetes, insulin-dependent diabetes, dyslipidemia, CAD, renal insufficiency) with Pearson's Chi-square test. The statistically significant outcomes will be subjected to sub-analysis with t-test, to identify the comparisons responsible for statistical significance.

Eligibility criteria: Inclusion Criteria:

* age \>18 years, both genders, being a patient with one type of vascular disease at the time of the study.

Exclusion Criteria:

* presence of more than one contemporary vascular disease at the time of the study, to avoid overlapping of concomitant vascular disease.
* presence of any illiteracy, or psychiatric issues that may impair understanding or self-administration of the questionnaire.
* malignancies.

Primary outcomes:
measure: Analysis of BMI
timeFrame: 32 months
measure: Analysis of waist circumference
timeFrame: 32 months
measure: Analysis of waist / hip ratio (WHR)
timeFrame: 32 months
measure: Analysis of waist / stature (WSR)
timeFrame: 32 months
measure: Analysis of ABSI "a body" score shape index
timeFrame: 32 months
measure: Administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ).
timeFrame: 32 months
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: University Magna Graecia of Catanzaro
Study officials:
affiliation: University Magna Graecia of Catanzaro
name: Raffaele Serra, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Zhu Q, Wang XB, Yao Y, Ning CX, Chen XP, Luan FX, Zhao YL. Association between anthropometric measures and cardiovascular disease (CVD) risk factors in Hainan centenarians: investigation based on the Centenarian's health study. BMC Cardiovasc Disord. 2018 May 2;18(1):73. doi: 10.1186/s12872-018-0810-8.
citation: Dhana K, Ikram MA, Hofman A, Franco OH, Kavousi M. Anthropometric measures in cardiovascular disease prediction: comparison of laboratory-based versus non-laboratory-based model. Heart. 2015 Mar;101(5):377-83. doi: 10.1136/heartjnl-2014-306704. Epub 2014 Dec 11.
citation: Venkatrao M, Nagarathna R, Patil SS, Singh A, Rajesh SK, Nagendra H. A composite of BMI and waist circumference may be a better obesity metric in Indians with high risk for type 2 diabetes: An analysis of NMB-2017, a nationwide cross-sectional study. Diabetes Res Clin Pract. 2020 Mar;161:108037. doi: 10.1016/j.diabres.2020.108037. Epub 2020 Jan 29.