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

M

Medical University of Bialystok

Status

Completed

Conditions

Obesity, Abdominal

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT05612282
N/ST/MN/17/003/3316

Details and patient eligibility

About

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.

Full 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.

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Enrollment

91 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

91 participants in 6 patient groups

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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