Brief Summary

The aim of the research was to assess the impact of the distribution of abdominal fat (subcutaneous SAT and visceral VAT estimated at the height of the navel) on selected metabolic parameters and on specific parameters of cardiopulmonary fitness in terms of people with obesity.

Trial Health

100

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Nov 2016

Shorter than P25 for all trials

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

12 months study duration

Study Start

First participant enrolled

November 11, 2016

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed

5 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed

15 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed

Last Updated

November 10, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

October 26, 2022

Last Update Submit

November 4, 2022

Conditions

Obesity, Abdominal

Keywords

Adipose tissueobesitymetabolic disorders

Outcome Measures

Primary Outcomes (5)

The impact of the body compositon parameters (BioScan 920-2) on the risk of metabolic complications of obesity with to use biochemical parameters.
The body weight (kg) was measured using a scale with stadiometer. The height (cm) was measured using a scale with stadiometer. This measurment is needed to calculate BMI (Body Mass Index) and to do a body composition analysis. The body composition parameters was determined using the bioimpedance method with a BioScan 920-2 body composition analyzer (Maltron,UK): fat mass (kg), percentage of body fat (%), muscle mass (kg),total body water (kg), basal metabolic rate (kcal). Laboratory tests were performed to determine the following serum levels: fasting glucose, fasting insulin, total cholesterol, LDL cholesterol fraction, HDL cholesterol fraction, triglycerides, C-reactive protein (CRP), uric acid, creatinine, and aminotrasferases: alanine (ALT) and aspartate (AST). On the basis of fasting glucose and fasting insulin. The HOMA - IR insulin resistance index was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
1 week
The impact of the abdominal adipose tissue (VAT, SAT or VAT/SAT) on the risk of metabolic complications of obesity with to use biochemical parameters.
Abdominal adipose tissue was determined using the bioimpedance method with a BioScan 920-2 body composition analyzer (Maltron,UK): visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) and VAT/SAT. Laboratory tests were performed to determine the following serum levels: fasting glucose, fasting insulin, total cholesterol, LDL cholesterol fraction, HDL cholesterol fraction, triglycerides, C-reactive protein (CRP), uric acid, creatinine, and aminotrasferases: alanine (ALT) and aspartate (AST). On the basis of fasting glucose and fasting insulin. The HOMA - IR insulin resistance index was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
1 week
The impact of abdominal adipose tissue distribution (VAT and SAT) on the parameters of cardiopulmonary efficiency.
Abdominal adipose tissue was determined using the bioimpedance method with a BioScan 920-2 body composition analyzer (Maltron,UK): visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) and VAT/SAT. Cardiopulmonary fitness was assessed using the Modified Bruce protocol.
1 week
Verification of the usefulness of selected anthropometric parameters in the assessment of the risk of developing metabolic disorders in obesity and their relationship with cardiovascular and respiratory efficiency.
An assessment of the status of nutrition based on anthropometric measurements was carried out: body mass index (body weight-kg/weight m2), Waist circumference measurements have been made to the nearest 0.1 centimeter using a tape measure at the uppermost lateral border of the hip crest, Hip circumference was measured at the greater trochanters at the widest part of the hips, Relative fat mass was calculated by the equation: 64-(20 x (height/waist circumference) Laboratory tests were performed to determine the following serum levels: fasting glucose, fasting insulin, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, C-reactive protein (CRP), uric acid, creatinine, and aminotrasferases: alanine and aspartate. On the basis of fasting glucose and fasting insulin The HOMA - IR insulin resistance index was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5 Cardiopulmonary fitness was assessed using the Modified Bruce protocol
1 week
The impact of dietary habbits and typicaly diet on on the risk of metabolic complications of obesity with to use biochemical parameters.
An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed. A 7-day nutrition interview was collected. The supply of energy, protein (including amino acids), fat (including fatty acids), carbohydrates, dietary fiber, vitamins and minerals in the usual diet was assessed. Laboratory tests were performed to determine the following serum levels: fasting glucose, fasting insulin, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, C-reactive protein (CRP), uric acid, creatinine, and aminotrasferases: alanine and aspartate. On the basis of fasting glucose and fasting insulin The HOMA - IR insulin resistance index was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5
1 week

Study Arms (6)

G1a - women

The G1a group consisted of women with obesity, in whom no additional components of the metabolic syndrome were found (n =16)

Diagnostic Test: body composition analysisOther: anthropometric measurementsOther: Interview questionnaireDiagnostic Test: biochemical parametersDiagnostic Test: cardiopulmonary fitness testOther: nutritional interview

G1b - men

The G1b group consisted of men with obesity, in whom no additional components of the metabolic syndrome were founds (n =6)

G2a - women

The G2a group consisted of women with obesity, in whom only one additional component of the metabolic syndrome was found (e.g. triglycerides ≥ 150 mg/dl, HDL cholesterol in women \< 50 mg/dl, and in men \< 40 mg/dl, or glycaemia ≥ 100 mg/dl), but it was not a disease previously diagnosed and treated (n=19)

G2b - men

The G2a group consisted of men with obesity, in whom only one additional component of the metabolic syndrome was found (e.g. triglycerides ≥ 150 mg/dl, HDL cholesterol in women \< 50 mg/dl, and in men \< 40 mg/dl, or glycaemia ≥ 100 mg/dl), but it was not a disease previously diagnosed and treated (n=11)

G3a - women

Group G3a consisted of women who met the full criteria for diagnosing the metabolic syndrome (n=24)

G3b - men

Group G3a consisted of men who met the full criteria for diagnosing the metabolic syndrome (n=15)

Interventions

body composition analysisDIAGNOSTIC_TEST

A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer