Evaluation Of DNA Methylation Pattern In Healthy, Sarcopenic, Obese And Sarcopenic Obese Older Women: A Cross-Sectional Study

NCT06618430 | Active Not Recruiting DMC

• 1 other identifier: 73189623.6.0000.5659
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION: Sarcopenic obesity (SO), a functional and clinical condition, is characterized by the coexistence of obesity, marked by excess fat mass and sarcopenia, characterized by reduced strength and muscle mass. SO is associated with a greater risk of health-related adverse clinical outcomes than older adults with obesity and sarcopenia alone. Aging is accompanied by numerous changes epigenetic. These aging-associated epigenetic changes include DNA methylation, histone modification, chromatin remodeling, non-coding RNA (ncRNA) regulation, and RNA modification. DNA methylation occurs at cytosines in CpG dinucleotides in the genome and undergoes changes with age in various human tissues. Furthermore, many genes can be hypermethylated or hypomethylated on CpG islands with the aging process. Soon, a broad exploration of candidate genes may provide insights into the pathogenesis of Sarcopenic obesity. Therefore, understanding how aging, specifically sarcopenia, obesity and Sarcopenic obesity, is regulated by epigenetic factors, favors the development of new treatment therapies. Thus, the objective will be to evaluate the epigenetic influence on sarcopenic obesity in older women. METHODS: This cross-sectional study will include 32 older women who will be classified as healthy, with sarcopenia, obesity and sarcopenic obesity living in the city of Ribeirão Preto - SP. The older adults will perform total and regional body scan using iDXA, anthropometric assessment, functional capacity tests, peripheral blood collection for analysis of biochemical markers and epigenetics. For statistical analysis will be used t test, ANOVA, linear regression models and Pearson correlation. Analyzes of the complete methylome will be performed using bioinformatics tools, including specific software. EXPECTED RESULTS: It is expected that there will be differences in the patterns of methylation and gene expression in the diseases analyzed. In addition, it is expected to clarify how epigenetic changes occur throughout this process.

Conditions

Sarcopenic Obesity; Sarcopenia; Obesity; Epigenesis, Genetic; Aging

Keywords

Sarcopenic Obesity; DNA Methylation; Aging

Outcome Measures

Primary Outcomes (1)

• Investigate whether the health condition (healthy, sarcopenic, obese or with sarcopenic obesity) promotes changes in DNA methylation

  For this purpose, blood samples will be collected in the morning after 12 hours of fasting in EDTA tubes by experienced nurses. 5 ml of blood will be collected for analysis of biochemical markers and genetic markers (DNA methylation and gene expression). DNA extraction from peripheral blood will be performed with the AllPrepDNA/RNA/miRNA Universal kit (Qiagen), according to the instructions, using 200 µL of the extracted material. The quality of the extracted DNA will be assessed with the Greends DNA Quantification Reagent (Invitrogen, Carlsbad, CA, USA). After extraction, the samples will be stored in a freezer at -80°C for analysis. DNA will be bisulfite converted using the EZ DNA Methylation-Gold Conversion Kit (Zymo Research, CA, USA) according to the instructions, with conversion of unmethylated cytosine to uracil. Array-based specific DNA methylation analysis will be performed using the Infinium Human Methylation 850K (EPIC) Beadchip technology.

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Study Arms (4)

Healthy older women

Older women who do not have sarcopenia, obesity or sarcopenic obesity.

Other: None (Observational Study)

Older women with sarcopenia

Older women with sarcopenia, i.e. low handgrip strength and low muscle mass index.

Other: None (Observational Study)

Older women with obesity

Older women with obesity

Other: None (Observational Study)

Older women with sarcopenic obesity

Older women with sarcopenic obesity, i.e. low handgrip strength, low muscle mass index and high body mass index.

Other: None (Observational Study)

Interventions

None (Observational Study) OTHER

None (Observational Study)

Healthy older women; Older women with obesity; Older women with sarcopenia; Older women with sarcopenic obesity

Eligibility Criteria

• Age: 60 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited through social media and on the website of the USP School of Physical Education and Sports (EEFERP/USP). Interested participants must register online and the researcher will then contact them by phone to schedule an interview.

You may qualify if:

• body mass (menor 120 kg);
• sedentary (not practicing physical exercise for at least 3 months);
• not using vitamin or mineral supplements, anxiolytic medications, hypoglycemic agents with activity on cytochrome P450 (CYP450) enzymes;
• classified within the criteria for sarcopenic obesity, sarcopenia and obesity.

You may not qualify if:

• alcoholics;
• smokers;
• infectious diseases;
• coronary diseases;
• chronic kidney diseases and
• presenting a score ≤ 13 for the cognitive examination in the Mini-Mental State Examination (MMSE).

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

University of Sao Paulo, School of Physical Education and Sports of Ribeirao Preto

Ribeirão Preto, São Paulo, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood collection Blood samples will be collected in the morning after a 12-hour fast in EDTA tubes by experienced nurses. 5 ml of blood will be collected for analysis of biochemical markers (after centrifugation and separation of the plasma, it will be stored in a freezer at -80 °C for analysis) and genetic markers (DNA methylation, gene expression). Blood collection has minimal risk (Category 2; 45 CFR 46.110). All blood samples will be coded at the time of collection.

MeSH Terms

Conditions

Sarcopenia; Obesity

Interventions

Observation

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: February 21, 2024
• Primary Completion: September 5, 2024
• Study Completion: October 5, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)