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

Obesity, Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05612282
• Other study ID #: N/ST/MN/17/003/3316
• Status: Completed
• Start date: November 11, 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: October 2022
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Diseases
• Obesity, Abdominal

Intervention

Diagnostic Test:
• body composition analysis
A body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer

Other:
• 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.

Diagnostic Test:
• 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

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Bialystok

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Osorio-Conles Ó, 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). pii: 2394. doi: 10.3390/ijms23042394. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week
Primary	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.	1 week
Primary	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.	1 week
Primary	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	1 week
Primary	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	1 week