Biomarkers of Metabolic Obesity.

NCT05604196 | Completed

• 2 other identifiers: SUB/3/DN/20/001/3316SUB/3/DN/21/001/3316
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

The main aims of the work: Analysis of the concentration of selected pro-inflammatory parameters in blood serum and saliva of people with different distribution of subcutaneous and visceral adipose tissue. Analysis of metabolic obesity biomarkers in saliva and blood serum. Evaluation of new diagnostic methods for the early determination of the risk of metabolic obesity and its complications. Based on the inclusion and exclusion criteria the observational study was conducted among 119 people (79 women and 41 men). Study group included 79 people (48 women and 31 men with obesity), and control group included 41 people (31 women and 10 men with normal body weight). The study consisted of three visits. The first included qualification for the study, body composition measurements, ankle-brachial index test and completing the questionnaires and 3-day nutrition diaries. At the second visit blood was collected to conduct the morphological test. At the third visit saliva was collected to determine the proinflammatory cytokine and adipokine concentration.

Conditions

Obesity

Keywords

obesity; saliva; blood serum; BMI; proinflammatory cytokines; proinflammatory adipokines; IL-6; IL-23; IL-1beta; resistin; TNF-alpha; MMP-2; MMP-9

Outcome Measures

Primary Outcomes (9)

• Analysis of the concentration of selected pro-inflammatory cytokines and adipokines in the saliva of patients with normal and excess body weight (obesity).

  Analysis of the concentration in saliva of MMP-9, MMP-2, IL-6, TNF-α, resistin, IL-1β, IL-23 in patients with normal and excess body weight (obesity).

  24 months (analyzes were performed throughout the study period).

• Analysis of the concentration of selected pro-inflammatory cytokines and adipokines in the blood serum of patients with normal and excess body weight (obesity).

  Analysis of the concentration in saliva of adiponectin, IL-6,TNF-α, MMP-9, MMP-2, resistin, IL-1β, IL-23 in patients with normal and excess body weight (obesity).

  24 months (analyzes were performed throughout the study period).

• Analysis of body composition of people with normal and excess body weight (obesity).

  In order to determine the body composition of the study participants, an electrical bioimpedance body composition analysis was carried out using the InBody 270 (South Korea, Seoul) device, which enabled the assessment of the following parameters: total body fat percentage, total lean body mass percentage, total body fat mass, total skeletal muscle mass, total body water (L), extracellular (L) and intracellular (L) water.

  24 months (analyzes were performed throughout the study period).

• Analysis of body composition and adipose tissue redistribution of people with normal and excess body weight (obesity).

  In order to determine the body composition of the study participants an electrical bioimpedance body composition analysis was carried out using the device: BioScan 920-2 (Great Britain, Essex), which enabled the assessment of the following parameters: total body fat percentage, total lean body mass percentage, total body fat mass, total skeletal muscle mass, total body water (L), extracellular (L) and intracellular (L) water. Also, the area of adipose tissue in the abdominal cross-section was determined: visceral (VAT- Visceral Adipose Tissue) and subcutaneous (SAT- Subcutaneous Adipose Tissue), and visceral to subcutaneous fat ratio (VAT / SAT ratio).

  24 months (analyzes were performed throughout the study period).

• Analysis of differences in the eating habits of people with normal and excessive body weight (obesity).

  All participants completed "Beliefs and Eating Habits Questionnaire" created by Behavioral Conditions of Nutrition Team Committee of Human Nutrition Science, Polish Academy of Science.

  24 months (analyzes were performed throughout the study period).

• Analysis of differences in the diet of people with normal and excessive body weight (obesity).

  All participants completed 3-day Nutrition Diary.

  24 months (analyzes were performed throughout the study period).

• Analysis of differences in physical activity of people with normal and excessive body weight (obesity).

  All participants completed "International Physical Activity Questionnaire - IPAQ".

  24 months (analyzes were performed throughout the study period).

• Analysis of differences in quality of life of people with normal and excessive body weight (obesity).

  All participants completed The World Health Organization Quality of Life (WHOQOL- BREF) survey.

  24 months (analyzes were performed throughout the study period).

• Risk assessment of lower limb atherosclerosis.

  An ankle-brachial index test compares the blood pressure measured at the ankle with the blood pressure measured at the arm was used in the study.

  24 months (analyzes were performed throughout the study period).

Study Arms (2)

STUDY GROUP

Study group included 79 people (48 women and 31 men), with BMI = 30.0-39.9 kg / m2) and excessive total body fat percent (TBF%) content (\>30% TBF women and \>25% TBF men).

CONTROL GROUP

Control group included 41 people (31 women and 10 men), with BMI = 18.5-24.9 kg / m2) and normal total body fat percent (TBF%) content (20-30% TBF women and 15-20% TBF men).

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

200 people volunteered for the study. The participants came from the Podlaskie Voivodeship, Poland. The first visit took place in the Department of Dietetics and Clinical Nutrition at the Medical University of Bialystok. Based on the inclusion and exclusion criteria the observational study was conducted among 119 people (79 women and 41 men).

You may qualify if:

• women and men aged 20-55
• primary obesity
• certificate from the dentist confirming the absence of periodontitis and inflammation in the oral cavity.

You may not qualify if:

• secondary obesity,
• type I and II diabetes,
• exacerbated coronary artery disease,
• endocrine disorders,
• eating disorders,
• pregnancy and lactation period,
• use of hormonal contraception or hormone replacement therapy, steroid therapy, antiretroviral therapy,
• surgical or pharmacological history obesity treatment,
• pacemaker

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

Medical University of Bialystok

Bialystok, 15-089, Poland

Location

Related Publications (5)

• Zhang CZ, Cheng XQ, Li JY, Zhang P, Yi P, Xu X, Zhou XD. Saliva in the diagnosis of diseases. Int J Oral Sci. 2016 Sep 29;8(3):133-7. doi: 10.1038/ijos.2016.38.

  PMID: 27585820 BACKGROUND

• Duffles LF, Hermont AP, Abreu LG, Pordeus IA, Silva TA. Association between obesity and adipokines levels in saliva and gingival crevicular fluid: A systematic review and meta-analysis. J Evid Based Med. 2019 Nov;12(4):313-324. doi: 10.1111/jebm.12363. Epub 2019 Sep 4.

  PMID: 31482694 BACKGROUND

• Zysk B, Ostrowska L, Smarkusz-Zarzecka J. Salivary Adipokine and Cytokine Levels as Potential Markers for the Development of Obesity and Metabolic Disorders. Int J Mol Sci. 2021 Oct 28;22(21):11703. doi: 10.3390/ijms222111703.

  PMID: 34769133 BACKGROUND

• Kunz HE, Hart CR, Gries KJ, Parvizi M, Laurenti M, Dalla Man C, Moore N, Zhang X, Ryan Z, Polley EC, Jensen MD, Vella A, Lanza IR. Adipose tissue macrophage populations and inflammation are associated with systemic inflammation and insulin resistance in obesity. Am J Physiol Endocrinol Metab. 2021 Jul 1;321(1):E105-E121. doi: 10.1152/ajpendo.00070.2021. Epub 2021 May 17.

  PMID: 33998291 BACKGROUND

• Ostrowska L, Gornowicz A, Pietraszewska B, Bielawski K, Bielawska A. Which salivary components can differentiate metabolic obesity? PLoS One. 2020 Jun 29;15(6):e0235358. doi: 10.1371/journal.pone.0235358. eCollection 2020.

  PMID: 32598403 BACKGROUND

Related Links

• World Health Assembly: Follow-up to the Political Declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases. (Paper WHA66.10) 2013, 1-55.
• World Obesity Federation: Global trends in obesity. \[in:\] Obesity: missing the 2025 global targets. Trends, Costs and Country Reports 2020, 16-33.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucyna Ostrowska, Professor

  Department of Dietetics and Clinical Nutrition Medical University of Bialystok

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 3, 2022
• Study Start: January 8, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-10

Locations

PL (1)