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临床试验/NCT05612282
NCT05612282已完成不适用

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

Medical University of Bialystok0 个研究点目标入组 91 人开始时间: 2016年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
91
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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.

时间窗: 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.

时间窗: 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.

时间窗: 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.

时间窗: 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.

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Medical University of Bialystok
申办方类型
Other
责任方
Sponsor

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