Clinical trial NCT05612282: The Impact of the Distribution of Adipose Tissue on the Occurrence of Metabolic Disorders and the Level of Cardiopulmonary Fitness
Official title: The Impact of the Distribution of Adipose Tissue on the Occurrence of Metabolic Disorders and and the Level of Cardiopulmonary Fitness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Abdominal
Keywords: Adipose tissue
obesity
metabolic disorders
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The research included 91 obese people (59 women and 32 men) who met the criteria for being included in the study and who did not possess exclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The impact of the body compositon parameters (BioScan 920-2) on the risk of metabolic complications of obesity with to use biochemical parameters.
timeFrame: 1 week
measure: 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.
timeFrame: 1 week
measure: The impact of abdominal adipose tissue distribution (VAT and SAT) on the parameters of cardiopulmonary efficiency.
timeFrame: 1 week
measure: 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.
timeFrame: 1 week
measure: The impact of dietary habbits and typicaly diet on on the risk of metabolic complications of obesity with to use biochemical parameters.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Bialystok
name: Katarzyna Witczak - Sawczuk, PhD
role: STUDY_DIRECTOR
affiliation: Medical University of Bialystok
name: Lucyna Ostrowska, Professor
role: STUDY_CHAIR
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