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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Abdominal

Intervention / Treatment
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* Diagnostic Test: body composition analysis
* Other: anthropometric measurements
* Other: Interview questionnaire
* Diagnostic Test: biochemical parameters
* Diagnostic Test: cardiopulmonary fitness test
* Other: nutritional interview


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| G1a - women<br>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 analysis<br>* A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer<br>Other: anthropometric measurements<br>* An assessment of the status of nutrition based on anthropometric measurements was carried out.<br>Other: Interview questionnaire<br>* An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.<br>Diagnostic Test: biochemical parameters<br>* 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.<br>Diagnostic Test: cardiopulmonary fitness test<br>* Cardiopulmonary fitness was assessed using the Modified Bruce protocol<br>Other: nutritional interview<br>* 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.<br>|
| G1b - men<br>The G1b group consisted of men with obesity, in whom no additional components of the metabolic syndrome were founds (n =6) | Diagnostic Test: body composition analysis<br>* A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer<br>Other: anthropometric measurements<br>* An assessment of the status of nutrition based on anthropometric measurements was carried out.<br>Other: Interview questionnaire<br>* An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.<br>Diagnostic Test: biochemical parameters<br>* 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.<br>Diagnostic Test: cardiopulmonary fitness test<br>* Cardiopulmonary fitness was assessed using the Modified Bruce protocol<br>Other: nutritional interview<br>* 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.<br>|
| G2a - women<br>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) | Diagnostic Test: body composition analysis<br>* A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer<br>Other: anthropometric measurements<br>* An assessment of the status of nutrition based on anthropometric measurements was carried out.<br>Other: Interview questionnaire<br>* An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.<br>Diagnostic Test: biochemical parameters<br>* 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.<br>Diagnostic Test: cardiopulmonary fitness test<br>* Cardiopulmonary fitness was assessed using the Modified Bruce protocol<br>Other: nutritional interview<br>* 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.<br>|
| G2b - men<br>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) | Diagnostic Test: body composition analysis<br>* A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer<br>Other: anthropometric measurements<br>* An assessment of the status of nutrition based on anthropometric measurements was carried out.<br>Other: Interview questionnaire<br>* An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.<br>Diagnostic Test: biochemical parameters<br>* 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.<br>Diagnostic Test: cardiopulmonary fitness test<br>* Cardiopulmonary fitness was assessed using the Modified Bruce protocol<br>Other: nutritional interview<br>* 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.<br>|
| G3a - women<br>Group G3a consisted of women who met the full criteria for diagnosing the metabolic syndrome (n=24) | Diagnostic Test: body composition analysis<br>* A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer<br>Other: anthropometric measurements<br>* An assessment of the status of nutrition based on anthropometric measurements was carried out.<br>Other: Interview questionnaire<br>* An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.<br>Diagnostic Test: biochemical parameters<br>* 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.<br>Diagnostic Test: cardiopulmonary fitness test<br>* Cardiopulmonary fitness was assessed using the Modified Bruce protocol<br>Other: nutritional interview<br>* 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.<br>|
| G3b - men<br>Group G3a consisted of men who met the full criteria for diagnosing the metabolic syndrome (n=15) | Diagnostic Test: body composition analysis<br>* A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer<br>Other: anthropometric measurements<br>* An assessment of the status of nutrition based on anthropometric measurements was carried out.<br>Other: Interview questionnaire<br>* An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.<br>Diagnostic Test: biochemical parameters<br>* 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.<br>Diagnostic Test: cardiopulmonary fitness test<br>* Cardiopulmonary fitness was assessed using the Modified Bruce protocol<br>Other: nutritional interview<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adipose tissue, obesity, metabolic disorders