The Impact of the Distribution of Adipose Tissue on the Occurrence of Metabolic Disorders and the Level of Cardiopulmonary Fitness

Completed

• Conditions: Obesity, Abdominal
• Interventions: Diagnostic Test: body composition analysis; Other: anthropometric measurements; Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cardiopulmonary fitness test; Other: nutritional interview

• Registration Number: NCT05612282
• Lead Sponsor: Medical University of Bialystok

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.

Detailed Description

The research was carried out in 3 stages. Stage 1 was carried out at the Department of Dietetics and Clinical Nutrition of the UMB. During the visit, the subjects were provided with detailed information concerning the research and every participant signed a voluntary consent to participate in the research. Furthermore, an interview questionnaire concerning the duration of obesity and past diseases was collected, and an assessment of the status of nutrition based on anthropometric measurements was carried out, and a body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer. Then, patients were issued a referral for laboratory examinations. Stage 2 was carried out at the Medical Laboratory at the University Clinical Hospital in Bialystok, where blood was taken from the ulnar vein (in the amount of 15ml). The concentrations of the following parameters were determined from the blood serum: 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. Stage 3 was carried out at the Maniac Gym Fitness Club in Bialystok, where cardiopulmonary fitness was assessed using the Modified Bruce protocol.

Study Timeline

• Study Start: 2016-11-11
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2022-10
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-11-04
• Last Update Submitted: 2022-11-04
• Study First Posted: 2022-11-10
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• primary obesity
• BMI ≥ 30kg/m2 - ≤ 39,99 kg/m2
• gender: women and men
• age: 20-65 lat

Exclusion Criteria

• secondry obesity
• BMI ≥ 40 kg/m2
• diabetes type 2 or insulin resistance (occurance or treatment)
• endocrine disorders
• eating disorders
• hormonal contraception/hormone replacement therapy
• after steroid therapy
• antiretroviral therapy
• musculoskeletal dysfunctions
• patients after surgery (min 3 months)
• bariatric surgery
• coronary artery disease
• cardiac pacemaker
• pregnancy
• breast - feeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
G3a - women	cardiopulmonary fitness test	Group G3a consisted of women who met the full criteria for diagnosing the metabolic syndrome (n=24)
G1b - men	biochemical parameters	The G1b group consisted of men with obesity, in whom no additional components of the metabolic syndrome were founds (n =6)
G3a - women	Interview questionnaire	Group G3a consisted of women who met the full criteria for diagnosing the metabolic syndrome (n=24)
G3a - women	anthropometric measurements	Group G3a consisted of women who met the full criteria for diagnosing the metabolic syndrome (n=24)
G1a - women	anthropometric measurements	The G1a group consisted of women with obesity, in whom no additional components of the metabolic syndrome were found (n =16)
G1b - men	Interview questionnaire	The G1b group consisted of men with obesity, in whom no additional components of the metabolic syndrome were founds (n =6)
G2b - men	body composition analysis	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)
G2b - men	nutritional interview	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	body composition analysis	Group G3a consisted of women who met the full criteria for diagnosing the metabolic syndrome (n=24)
G1a - women	biochemical parameters	The G1a group consisted of women with obesity, in whom no additional components of the metabolic syndrome were found (n =16)
G1b - men	body composition analysis	The G1b group consisted of men with obesity, in whom no additional components of the metabolic syndrome were founds (n =6)
G1b - men	anthropometric measurements	The G1b group consisted of men with obesity, in whom no additional components of the metabolic syndrome were founds (n =6)
G2a - women	cardiopulmonary fitness test	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)
G2a - women	nutritional interview	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)
G1a - women	body composition analysis	The G1a group consisted of women with obesity, in whom no additional components of the metabolic syndrome were found (n =16)
G1b - men	cardiopulmonary fitness test	The G1b group consisted of men with obesity, in whom no additional components of the metabolic syndrome were founds (n =6)
G1b - men	nutritional interview	The G1b group consisted of men with obesity, in whom no additional components of the metabolic syndrome were founds (n =6)
G2a - women	body composition analysis	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)
G2a - women	anthropometric measurements	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)
G2a - women	Interview questionnaire	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	anthropometric measurements	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)
G2b - men	Interview questionnaire	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)
G1a - women	Interview questionnaire	The G1a group consisted of women with obesity, in whom no additional components of the metabolic syndrome were found (n =16)
G1a - women	cardiopulmonary fitness test	The G1a group consisted of women with obesity, in whom no additional components of the metabolic syndrome were found (n =16)
G1a - women	nutritional interview	The G1a group consisted of women with obesity, in whom no additional components of the metabolic syndrome were found (n =16)
G2a - women	biochemical parameters	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	biochemical parameters	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)
G2b - men	cardiopulmonary fitness test	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	biochemical parameters	Group G3a consisted of women who met the full criteria for diagnosing the metabolic syndrome (n=24)
G3b - men	body composition analysis	Group G3a consisted of men who met the full criteria for diagnosing the metabolic syndrome (n=15)
G3b - men	cardiopulmonary fitness test	Group G3a consisted of men who met the full criteria for diagnosing the metabolic syndrome (n=15)
G3b - men	nutritional interview	Group G3a consisted of men who met the full criteria for diagnosing the metabolic syndrome (n=15)
G3a - women	nutritional interview	Group G3a consisted of women who met the full criteria for diagnosing the metabolic syndrome (n=24)
G3b - men	Interview questionnaire	Group G3a consisted of men who met the full criteria for diagnosing the metabolic syndrome (n=15)
G3b - men	biochemical parameters	Group G3a consisted of men who met the full criteria for diagnosing the metabolic syndrome (n=15)
G3b - men	anthropometric measurements	Group G3a consisted of men who met the full criteria for diagnosing the metabolic syndrome (n=15)

Primary Outcome Measures

Name	Time	Method
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.	1 week	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
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.	1 week	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.
The impact of abdominal adipose tissue distribution (VAT and SAT) on the parameters of cardiopulmonary efficiency.	1 week	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.
The impact of the body compositon parameters (BioScan 920-2) on the risk of metabolic complications of obesity with to use biochemical parameters.	1 week	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.
The impact of dietary habbits and typicaly diet on on the risk of metabolic complications of obesity with to use biochemical parameters.	1 week	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