The Impact of the Distribution of Adipose Tissue on the Occurrence of Metabolic Disorders and the Level of Cardiopulmonary Fitness
NCT ID: NCT05612282
Last Updated: 2022-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
91 participants
OBSERVATIONAL
2016-11-11
2017-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Biomarkers of Metabolic Obesity.
NCT05604196
Visceral Adiposity and CVD Risk in Women
NCT00021879
Association Between Abdominal Body Composition, Inflammation, and Risk for Cardiovascular Disease (The MESA ABD Study)
NCT00612365
Effect of Weight Loss on Cardiovascular Disease Risk Factors in Obese Women
NCT01353001
Sex and Obesity: Effects on Heart Failure Study
NCT00776035
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CROSSOVER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
G1a - women
The G1a group consisted of women with obesity, in whom no additional components of the metabolic syndrome were found (n =16)
body composition analysis
A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer
anthropometric measurements
An assessment of the status of nutrition based on anthropometric measurements was carried out.
Interview questionnaire
An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.
biochemical parameters
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 test
Cardiopulmonary fitness was assessed using the Modified Bruce protocol
nutritional interview
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.
G1b - men
The G1b group consisted of men with obesity, in whom no additional components of the metabolic syndrome were founds (n =6)
body composition analysis
A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer
anthropometric measurements
An assessment of the status of nutrition based on anthropometric measurements was carried out.
Interview questionnaire
An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.
biochemical parameters
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 test
Cardiopulmonary fitness was assessed using the Modified Bruce protocol
nutritional interview
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.
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)
body composition analysis
A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer
anthropometric measurements
An assessment of the status of nutrition based on anthropometric measurements was carried out.
Interview questionnaire
An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.
biochemical parameters
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 test
Cardiopulmonary fitness was assessed using the Modified Bruce protocol
nutritional interview
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.
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)
body composition analysis
A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer
anthropometric measurements
An assessment of the status of nutrition based on anthropometric measurements was carried out.
Interview questionnaire
An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.
biochemical parameters
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 test
Cardiopulmonary fitness was assessed using the Modified Bruce protocol
nutritional interview
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.
G3a - women
Group G3a consisted of women who met the full criteria for diagnosing the metabolic syndrome (n=24)
body composition analysis
A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer
anthropometric measurements
An assessment of the status of nutrition based on anthropometric measurements was carried out.
Interview questionnaire
An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.
biochemical parameters
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 test
Cardiopulmonary fitness was assessed using the Modified Bruce protocol
nutritional interview
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.
G3b - men
Group G3a consisted of men who met the full criteria for diagnosing the metabolic syndrome (n=15)
body composition analysis
A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer
anthropometric measurements
An assessment of the status of nutrition based on anthropometric measurements was carried out.
Interview questionnaire
An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.
biochemical parameters
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 test
Cardiopulmonary fitness was assessed using the Modified Bruce protocol
nutritional interview
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
body composition analysis
A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer
anthropometric measurements
An assessment of the status of nutrition based on anthropometric measurements was carried out.
Interview questionnaire
An interview questionnaire concerning the duration of obesity and past diseases was collected. Moreover, the diet and nutritional status were assessed.
biochemical parameters
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 test
Cardiopulmonary fitness was assessed using the Modified Bruce protocol
nutritional interview
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI ≥ 30kg/m2 - ≤ 39,99 kg/m2
* gender: women and men
* age: 20-65 lat
Exclusion Criteria
* 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
20 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Bialystok
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Katarzyna Witczak - Sawczuk, PhD
Role: STUDY_DIRECTOR
Medical University of Bialystok
Lucyna Ostrowska, Professor
Role: STUDY_CHAIR
Medical University of Bialystok
References
Explore related publications, articles, or registry entries linked to this study.
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.
Pimentel 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.
Hoddy 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.
Perreault 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.
Kim 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.
Zhou 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.
Numao 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.
Matsha 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.
Osorio-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.
Schorr 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.
Chashmniam 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.
Kaess 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
N/ST/MN/17/003/3316
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.