Obesity, AbdominalNCT05612282
The Impact of the Distribution of Adipose Tissue on the Occurrence of Metabolic Disorders and the Level of Cardiopulmonary Fitness
An observational study of Obesity, Abdominal, run by Medical University of Bialystok.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- body composition analysis, anthropometric measurements and Interview questionnaire
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2016to 31 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- primary obesity
- BMI ≥ 30kg/m2 - ≤ 39,99 kg/m2
- gender: women and men
- age: 20-65 lat
Who cannot join
- secondry obesity
- BMI ≥ 40 kg/m2
- diabetes type 2 or insulin resistance (occurance or treatment)
- endocrine disorders
- eating disorders
- hormonal contraception/hormone replacement therapy
Show all 15Show fewer
- after steroid therapy
- antiretroviral therapy
- musculoskeletal dysfunctions
- patients after surgery (min 3 months)
- bariatric surgery
- coronary artery disease
- cardiac pacemaker
- pregnancy
- breast - feeding
About this study
Official title: The Impact of the Distribution of Adipose Tissue on the Occurrence of Metabolic Disorders and and the Level of Cardiopulmonary Fitness
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.
Read the 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.
- Conditions
- Obesity, Abdominal
- Being tested
- body composition analysis, anthropometric measurements, Interview questionnaire, biochemical parameters, cardiopulmonary fitness test
- Keywords
- Adipose tissue, obesity, metabolic disorders
- Medical subject headings
- Obesity, Abdominal, Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body composition analysisDiagnostic test
A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer
anthropometric measurementsOther
An assessment of the status of nutrition based on anthropometric measurements was carried out.
Interview questionnaireOther
An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.
biochemical parametersDiagnostic test
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.
cardiopulmonary fitness testDiagnostic test
Cardiopulmonary fitness was assessed using the Modified Bruce protocol
nutritional interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| G1a - women | The G1a group consisted of women with obesity, in whom no additional components of the metabolic syndrome were found (n =16) Receives: Diagnostic Test: body composition analysis; Other: anthropometric measurements; Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cardiopulmonary fitness test; Other: nutritional interview | |
| G1b - men | The G1b group consisted of men with obesity, in whom no additional components of the metabolic syndrome were founds (n =6) Receives: Diagnostic Test: body composition analysis; Other: anthropometric measurements; Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cardiopulmonary fitness test; Other: nutritional interview | |
| G2a - women | 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) Receives: Diagnostic Test: body composition analysis; Other: anthropometric measurements; Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cardiopulmonary fitness test; Other: nutritional interview | |
| G2b - men | 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) Receives: Diagnostic Test: body composition analysis; Other: anthropometric measurements; Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cardiopulmonary fitness test; Other: nutritional interview | |
| G3a - women | Group G3a consisted of women who met the full criteria for diagnosing the metabolic syndrome (n=24) Receives: Diagnostic Test: body composition analysis; Other: anthropometric measurements; Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cardiopulmonary fitness test; Other: nutritional interview | |
| G3b - men | Group G3a consisted of men who met the full criteria for diagnosing the metabolic syndrome (n=15) Receives: Diagnostic Test: body composition analysis; Other: anthropometric measurements; Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cardiopulmonary fitness test; Other: nutritional interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start11 Nov 2016
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katarzyna Witczak - Sawczuk, PhD, Study director, Medical University of BialystokLucyna Ostrowska, Professor, Study chair, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612282
- Sponsor's protocol ID
- N/ST/MN/17/003/3316
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mongraw-Chaffin M, Foster MC, Anderson CAM, Burke GL, Haq N, Kalyani RR, Ouyang P, Sibley CT, Tracy R, Woodward M, Vaidya D. Metabolically Healthy Obesity, Transition to Metabolic Syndrome, and Cardiovascular Risk. J Am Coll Cardiol. 2018 May 1;71(17):1857-1865. doi: 10.1016/j.jacc.2018.02.055.
PubMed 29699611Pimentel Ade C, Scorsatto M, de Oliveira GM, Rosa G, Luiz RR. Characterization of metabolically healthy obese Brazilians and cardiovascular risk prediction. Nutrition. 2015 Jun;31(6):827-33. doi: 10.1016/j.nut.2014.12.024. Epub 2015 Jan 10.
PubMed 25933489Hoddy KK, Axelrod CL, Mey JT, Hari A, Beyl RA, Blair JB, Dantas WS, Kirwan JP. Insulin resistance persists despite a metabolically healthy obesity phenotype. Obesity (Silver Spring). 2022 Jan;30(1):39-44. doi: 10.1002/oby.23312. Epub 2021 Nov 24.
PubMed 34816598Perreault M, Zulyniak MA, Badoud F, Stephenson S, Badawi A, Buchholz A, Mutch DM. A distinct fatty acid profile underlies the reduced inflammatory state of metabolically healthy obese individuals. PLoS One. 2014 Feb 10;9(2):e88539. doi: 10.1371/journal.pone.0088539. eCollection 2014.
PubMed 24520395Kim H, Yoon E, Kim OY, Kim EM. Short-term Effects of Eating Behavior Modification on Metabolic Syndrome-Related Risks in Overweight and Obese Korean Adults. J Obes Metab Syndr. 2022 Mar 30;31(1):70-80. doi: 10.7570/jomes21074.
PubMed 35296564Zhou YH, Guo Y, Wang F, Zhou CL, Tang CY, Tang HN, Yan DW, Zhou HD. Association of Sex Hormones and Fat Distribution in Men with Different Obese and Metabolic Statuses. Int J Gen Med. 2022 Feb 9;15:1225-1238. doi: 10.2147/IJGM.S351282. eCollection 2022.
PubMed 35173463Numao S, So R, Matsuo T, Nakagaichi M, Tanaka K. A favorable metabolic profile in metabolically healthy obesity is associated with physical activity level rather than abdominal fat volume in Japanese males. J Phys Ther Sci. 2021 Feb;33(2):137-141. doi: 10.1589/jpts.33.137. Epub 2021 Feb 13.
PubMed 33642688Matsha TE, Ismail S, Speelman A, Hon GM, Davids S, Erasmus RT, Kengne AP. Visceral and subcutaneous adipose tissue association with metabolic syndrome and its components in a South African population. Clin Nutr ESPEN. 2019 Aug;32:76-81. doi: 10.1016/j.clnesp.2019.04.010. Epub 2019 Jun 3.
PubMed 31221294Osorio-Conles O, Vega-Beyhart A, Ibarzabal A, Balibrea JM, Vidal J, de Hollanda A. Biological Determinants of Metabolic Syndrome in Visceral and Subcutaneous Adipose Tissue from Severely Obese Women. Int J Mol Sci. 2022 Feb 21;23(4):2394. doi: 10.3390/ijms23042394.
PubMed 35216509Schorr M, Dichtel LE, Gerweck AV, Valera RD, Torriani M, Miller KK, Bredella MA. Sex differences in body composition and association with cardiometabolic risk. Biol Sex Differ. 2018 Jun 27;9(1):28. doi: 10.1186/s13293-018-0189-3.
PubMed 29950175Chashmniam S, Hashemi Madani N, Nobakht Mothlagh Ghoochani BF, Safari-Alighiarloo N, Khamseh ME. The metabolome profiling of obese and non-obese individuals: Metabolically healthy obese and unhealthy non-obese paradox. Iran J Basic Med Sci. 2020 Feb;23(2):186-194. doi: 10.22038/IJBMS.2019.37885.9004.
PubMed 32405361Kaess BM, Pedley A, Massaro JM, Murabito J, Hoffmann U, Fox CS. The ratio of visceral to subcutaneous fat, a metric of body fat distribution, is a unique correlate of cardiometabolic risk. Diabetologia. 2012 Oct;55(10):2622-2630. doi: 10.1007/s00125-012-2639-5. Epub 2012 Aug 17.
PubMed 22898763
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Distribution of Adipose Tissue on the Occurrence of Metabolic Disorders and and the Level of Cardiopulmonary Fitness
- ClinicalTrials.gov ID
- NCT05612282
- Acronym / sponsor ID
- N/ST/MN/17/003/3316
- Conditions
- Obesity, Abdominal
- Keywords
- Adipose tissue, obesity, metabolic disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| G1a - women | – | Diagnostic Test: body composition analysis, Other: anthropometric measurements, Other: Interview questionnaire, Diagnostic Test: biochemical parameters, Diagnostic Test: cardiopulmonary fitness test, Other: nutritional interviewThe G1a group consisted of women with obesity, in whom no additional components of the metabolic syndrome were found (n =16) |
| G1b - men | – | Diagnostic Test: body composition analysis, Other: anthropometric measurements, Other: Interview questionnaire, Diagnostic Test: biochemical parameters, Diagnostic Test: cardiopulmonary fitness test, Other: nutritional interviewThe G1b group consisted of men with obesity, in whom no additional components of the metabolic syndrome were founds (n =6) |
| G2a - women | – | Diagnostic Test: body composition analysis, Other: anthropometric measurements, Other: Interview questionnaire, Diagnostic Test: biochemical parameters, Diagnostic Test: cardiopulmonary fitness test, Other: nutritional interviewThe 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 | – | Diagnostic Test: body composition analysis, Other: anthropometric measurements, Other: Interview questionnaire, Diagnostic Test: biochemical parameters, Diagnostic Test: cardiopulmonary fitness test, Other: nutritional interviewThe 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 | – | Diagnostic Test: body composition analysis, Other: anthropometric measurements, Other: Interview questionnaire, Diagnostic Test: biochemical parameters, Diagnostic Test: cardiopulmonary fitness test, Other: nutritional interviewGroup G3a consisted of women who met the full criteria for diagnosing the metabolic syndrome (n=24) |
| G3b - men | – | Diagnostic Test: body composition analysis, Other: anthropometric measurements, Other: Interview questionnaire, Diagnostic Test: biochemical parameters, Diagnostic Test: cardiopulmonary fitness test, Other: nutritional interviewGroup G3a consisted of men who met the full criteria for diagnosing the metabolic syndrome (n=15) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- primary obesity
- BMI ≥ 30kg/m2 - ≤ 39,99 kg/m2
- gender: women and men
- age: 20-65 lat
Key exclusion criteria (15 listed)
- secondry obesity
- BMI ≥ 40 kg/m2
- diabetes type 2 or insulin resistance (occurance or treatment)
- endocrine disorders
- eating disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| body composition analysisA body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer | Diagnostic test | G1a - women, G1b - men, G2a - women, G2b - men, G3a - women, G3b - men |
| anthropometric measurementsAn assessment of the status of nutrition based on anthropometric measurements was carried out. | Other | G1a - women, G1b - men, G2a - women, G2b - men, G3a - women, G3b - men |
| Interview questionnaireAn interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed. | Other | G1a - women, G1b - men, G2a - women, G2b - men, G3a - women, G3b - men |
| biochemical parametersThe 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. | Diagnostic test | G1a - women, G1b - men, G2a - women, G2b - men, G3a - women, G3b - men |
| cardiopulmonary fitness testCardiopulmonary fitness was assessed using the Modified Bruce protocol | Diagnostic test | G1a - women, G1b - men, G2a - women, G2b - men, G3a - women, G3b - men |
| nutritional interviewA 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. | Other | G1a - women, G1b - men, G2a - women, G2b - men, G3a - women, G3b - men |
Primary outcome
The impact of the body compositon parameters (BioScan 920-2) on the risk of metabolic complications of obesity with to use biochemical parameters.
Time frame: 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 the abdominal adipose tissue (VAT, SAT or VAT/SAT) on the risk of metabolic complications of obesity with to use biochemical parameters.
Time frame: 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.
Time frame: 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.
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.
Time frame: 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 dietary habbits and typicaly diet on on the risk of metabolic complications of obesity with to use biochemical parameters.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Background: PubMed 29699611Mongraw-Chaffin M, Foster MC, Anderson CAM, Burke GL, Haq N, Kalyani RR, Ouyang P, Sibley CT, Tracy R, Woodward M, Vaidya D. Metabolically Healthy Obesity, Transition to Metabolic Syndrome, and Cardiovascular Risk. J Am Coll Cardiol. 2018 May 1;71(17):1857-1865. doi: 10.1016/j.jacc.2018.02.055.
- Background: PubMed 25933489Pimentel Ade C, Scorsatto M, de Oliveira GM, Rosa G, Luiz RR. Characterization of metabolically healthy obese Brazilians and cardiovascular risk prediction. Nutrition. 2015 Jun;31(6):827-33. doi: 10.1016/j.nut.2014.12.024. Epub 2015 Jan 10.
- Background: PubMed 34816598Hoddy KK, Axelrod CL, Mey JT, Hari A, Beyl RA, Blair JB, Dantas WS, Kirwan JP. Insulin resistance persists despite a metabolically healthy obesity phenotype. Obesity (Silver Spring). 2022 Jan;30(1):39-44. doi: 10.1002/oby.23312. Epub 2021 Nov 24.
- Background: PubMed 24520395Perreault M, Zulyniak MA, Badoud F, Stephenson S, Badawi A, Buchholz A, Mutch DM. A distinct fatty acid profile underlies the reduced inflammatory state of metabolically healthy obese individuals. PLoS One. 2014 Feb 10;9(2):e88539. doi: 10.1371/journal.pone.0088539. eCollection 2014.
- Background: PubMed 35296564Kim H, Yoon E, Kim OY, Kim EM. Short-term Effects of Eating Behavior Modification on Metabolic Syndrome-Related Risks in Overweight and Obese Korean Adults. J Obes Metab Syndr. 2022 Mar 30;31(1):70-80. doi: 10.7570/jomes21074.
- Background: PubMed 35173463Zhou YH, Guo Y, Wang F, Zhou CL, Tang CY, Tang HN, Yan DW, Zhou HD. Association of Sex Hormones and Fat Distribution in Men with Different Obese and Metabolic Statuses. Int J Gen Med. 2022 Feb 9;15:1225-1238. doi: 10.2147/IJGM.S351282. eCollection 2022.
- Background: PubMed 33642688Numao S, So R, Matsuo T, Nakagaichi M, Tanaka K. A favorable metabolic profile in metabolically healthy obesity is associated with physical activity level rather than abdominal fat volume in Japanese males. J Phys Ther Sci. 2021 Feb;33(2):137-141. doi: 10.1589/jpts.33.137. Epub 2021 Feb 13.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna Witczak - Sawczuk, PhD study director
Medical University of Bialystok
Lucyna Ostrowska, Professor study chair
Medical University of Bialystok
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Abdominal, run by Medical University of Bialystok.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of the body compositon parameters (BioScan 920-2) on the risk of metabolic complications of obesity with to use biochemical parameters. (time frame: 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05612282, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.