The Project ATA: Adipose Tissue & Adipokines

Sponsor
Dynamical Business and Science Society - DBSS International SAS (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05758311
Collaborator
CES University (Other), Universidad de Córdoba (Other)
378
1
18
21

Study Details

Study Description

Brief Summary

It is essential to delve deeper into the molecular and tissue aspects that allow us to recognize the roles of adipose tissue and its interaction with the musculoskeletal (i.e., adipomyokines) to facilitate the identification of biomarkers that can complement the assessment of body composition. Thus, investigators posed the following research question: what characteristics of adipose tissue can investigators consider to rethink assessment for the diagnosis and treatment of obesity? The 'Project ATA' is a cross-sectional study based on the Strengthening the Reporting of Observational Studies in Epidemiology-Nutritional Epidemiology (STROBE-nut) guidelines, an Extension of the STROBE Statement. The FINER strategy (Feasible, Interesting, Novel, Ethical, and Relevant) and previously published guidelines for organizing a multicenter study will be followed. The 'Project ATA' will test the associations of several morphological metrics and adipomyokines in order to both profile populations with excess body fat and to establish practical geographical-based recommendations for practitioners.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Obesity is a multifactorial disease characterized by excess and accumulation of body fat, which implies hypertrophy and hyperplasia of adipocytes (i.e. adipose tissue cells). However, obesity is not only related to lipid accumulation in adipose tissue but could also generate morpho-functional changes in other tissues. The deleterious effects of lipid accumulation in non-adipose tissues are known as lipotoxicity. Lipotoxicity generates certain metabolic alterations, which affect overall metabolic health, leading to ectopic fat accumulation (i.e. fat accumulation outside its proper place). These factors can result in an increased likelihood of chronic diseases, including cardiovascular disease, type 2 diabetes mellitus, non-alcoholic fatty liver disease, chronic kidney disease, and different types of cancer. There is substantial variation between individuals, some obese people may remain metabolically healthy and some lean people may have metabolic diseases. Additionally, adipose tissue in addition to having an energy storage role produces hormones that regulate different physiological processes, such as inflammatory responses, mechanical cushioning and insulation, and participation in heat production for body temperature regulation. These processes can change adaptively (or maladaptation) during the loss or gain of body mass. Importantly, insufficient adipose tissue (lipodystrophy) or adipose tissue dysfunction (e.g. obesity) leads to excessive lipid deposition in other organs such as the liver and muscle.

    Obesity comprises much damage in different tissues of the organism; however, these changes are potentially reversible by taking advantage of the innate property of biological systems to favor adaptation to repeated stimuli (e.g., changes in habits and lifestyles). The particularity of obesity is the expansion of adipose tissue, although this does not always mean that it is pathological. A clear example is natural obesity in various mammals during the pre-hibernation stage and subsequent periods of high physical activity. Healthy adipose tissue expansion is accompanied by adequate capillary angiogenesis and mitochondria-centered metabolic control. On the other hand, unhealthy adipose tissue expansion is associated with capillary and mitochondrial impairment, resulting in immune cell deposition and excessive production of proinflammatory cytokines. In addition, some pathologies of metabolically healthy obese individuals have well-preserved adipose tissue function, associated with fewer comorbidities and lower mortality rates compared to lean individuals.

    The reasons for studying beyond the energetic function of adipose tissue are based on the plasticity of adipose tissue and its different types (both morphological and metabolic). Traditionally, adipose tissue is classified as white adipose tissue (WAT), brown adipose tissue (BAT), and beige adipose tissue (bAT). However, other types of adipose tissue have been identified, including pink and yellow (bone marrow) adipose tissue, highlighting their physiological functions after trans-differentiation processes. It is necessary to establish an understanding of the complexity of adipose tissue and its endocrine interaction with other tissues to determine the physiological response to external stimuli (e.g., overenergetic diet, physical inactivity, sedentary lifestyle, cancer, etc.). In fact, a geographical variation of obesity and the associated risk factors has been reported by different research groups. This questions and highlights the need to improve the obesity metrics for diagnosis and monitoring.

    The aim of 'Project ATA' is double: i) to profile the population with excess fat mass (overweight and obesity) using body composition data and the concentration of adipomyokines, and ii) to evaluate the association between morphophysiological and endocrine variables in order to propose practical geographical-based recommendations to assess and monitor obesity accurately.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    378 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Adipose Tissue & Adipokines (ATA): From Laboratory to Clinical Practice - The Project ATA
    Anticipated Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Multi-center study

    The study population will be inhabitants of both sexes with different levels of physical activity who reside in the metropolitan area of cities in Colombia, Mexico, Costa Rica, and Spain. The population sample will be obtained through an internal call to students and administrative personnel of universities and Smart Fit sites with an inter-institutional collaboration agreement with Dynamical Business & Science Society (DBSS International). The first study will be carried out in Colombia.

    Outcome Measures

    Primary Outcome Measures

    1. Anthropometric Assessment [July 2023 to August 2024]

      All measurements will be performed according to the International Standards for Anthropometric Evaluation published by the International Society for the Advancement of Kineanthropometry (ISAK) to obtain basic measurements expressed in absolute data. Means will be calculated and analyzed from two measurements of anthropometric data.

    2. Anthropometry-Based Analysis of Body Composition [July 2023 to August 2024]

      The whole-body fat percentage (RFM), the sum of skinfolds, the waist girth (minimal and umbilicus), the body mass to waist girth, waist girth to stature ratios. Finally, musculoskeletal index, the skinfold-corrected muscle girths for the arm, chest, waist, thigh, and calf will be calculated according to the expression: girth - (π x skinfold).

    3. Bioelectrical Impedance Analysis [July 2023 to August 2024]

      To evaluate adult subjects with excess adiposity by foot-to-foot bioelectrical impedance analysis (BIA). Estimated values of percent fat mass (FM), percent muscle mass (MA), metabolic age (ma), basal metabolic rate (BMR), and visceral fat (VFL). In addition, bioelectrical impedance vector analysis (BIVA) will be performed and raw variables related to phase angle and body composition will be reported.

    4. Adipokines and blood screening [July 2023 to August 2024]

      Will be collected peripheral blood samples, where it will be taken into account serum amyloid A, resistin, leptin, adiponectin, and visfatin concentrations will be quantified by direct chemiluminescence using acridinium ester technology.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • People over 18 years of age (under 60 years of age).

    • People born and residing in major cities or neighboring municipalities of the metropolitan area of selected cities. The first stage will take place in Medellín (Colombia) and then continue in other cities in Colombia, Costa Rica, Mexico, and Spain according to logistics procedures.

    • Those who sign the informed consent to undergo the measurements.

    Exclusion Criteria:
    • Those physically active people who exercise vigorously and systematically or at a competitive level.

    • Those diagnosed with a musculoskeletal disease and/or special condition that limits mobility during the taking of measurements (musculoskeletal injury).

    • People over 60 years of age.

    • Pregnant women.

    • People with implants or synthetic prostheses.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 DBSS Bogotá Colombia 110311

    Sponsors and Collaborators

    • Dynamical Business and Science Society - DBSS International SAS
    • CES University
    • Universidad de Córdoba

    Investigators

    • Principal Investigator: Diego A Bonilla, MSc, Research Division, Dynamical Business & Science Society - DBSS International SAS, Bogotá, Colombia
    • Principal Investigator: Luis M Gómez-Miranda, PhD, Sports School, Autonomous University of Baja California, Tijuana 22390, México
    • Principal Investigator: Daniel Rojas-Valverde, PhD, Núcleo de Estudios para el Alto Rendimiento y la Salud (CIDISAD-NARS), Heredia, Costa Rica
    • Principal Investigator: Salvador Vargas-Molina, MSc, Faculty of Sport Sciences, EADE-University of Wales Trinity Saint David, 29018 Málaga, Spain
    • Principal Investigator: Katherine Franco-Hoyos, MSc, Nutral, Universidad CES, Medellín, Colombia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dynamical Business and Science Society - DBSS International SAS
    ClinicalTrials.gov Identifier:
    NCT05758311
    Other Study ID Numbers:
    • ATA_DBSS
    First Posted:
    Mar 7, 2023
    Last Update Posted:
    Mar 7, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dynamical Business and Science Society - DBSS International SAS
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 7, 2023