The Project ATA: Adipose Tissue & Adipokines

Obesity Clinical Trial

— ATA  

Official title:

Adipose Tissue & Adipokines (ATA): From Laboratory to Clinical Practice - The Project ATA

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05758311
• Other study ID #: ATA_DBSS
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Dynamical Business and Science Society - DBSS International SAS
• Contact: Diego A Bonilla, MSc
• Phone: (57)3203352050
• Email: dabonilla[@]dbss.pro
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 378
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Sedentary Behavior

Locations

Country	Name	City	State
Colombia	DBSS	Bogotá

Sponsors (3)

Lead Sponsor	Collaborator
Dynamical Business and Science Society - DBSS International SAS	CES University, Universidad de Córdoba

Country where clinical trial is conducted

Colombia, 

References & Publications (3)

Apovian CM. Obesity: definition, comorbidities, causes, and burden. Am J Manag Care. 2016 Jun;22(7 Suppl):s176-85. — View Citation

Bonilla DA, De Leon LG, Alexander-Cortez P, Odriozola-Martinez A, Herrera-Amante CA, Vargas-Molina S, Petro JL. Simple anthropometry-based calculations to monitor body composition in athletes: Scoping review and reference values. Nutr Health. 2022 Mar;28(1):95-109. doi: 10.1177/02601060211002941. Epub 2021 Apr 1. — View Citation

Bremner JD, Moazzami K, Wittbrodt MT, Nye JA, Lima BB, Gillespie CF, Rapaport MH, Pearce BD, Shah AJ, Vaccarino V. Diet, Stress and Mental Health. Nutrients. 2020 Aug 13;12(8):2428. doi: 10.3390/nu12082428. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometric Assessment	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.	July 2023 to August 2024
Primary	Anthropometry-Based Analysis of Body Composition	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 - (p x skinfold).	July 2023 to August 2024
Primary	Bioelectrical Impedance Analysis	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.	July 2023 to August 2024
Primary	Adipokines and blood screening	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.	July 2023 to August 2024