Sarcopenic ObesityNCT06618430
Evaluation Of DNA Methylation Pattern In Healthy, Sarcopenic, Obese And Sarcopenic Obese Older Women: A Cross-Sectional Study
An observational study of Sarcopenic Obesity and Sarcopenia, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenic Obesity, Sarcopenia, Obesity
- What is being tested?
- None (Observational Study)
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Feb 2024to 5 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo, School of Physical Education and Sports of Ribeirao Preto
Ribeirão Preto, São Paulo
About this study
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.
Read the detailed description
The sample size was calculated a priori, considering DNA methylation as the primary outcome, on an exploratory basis. The analyses were conducted using R software (https://www.r-project.org). For the calculation, an effect size of 0.65, alpha 0.05 and statistical power of 0.80 were used. Thus, a total of 32 participants will be included in the study (n = 8 in each group). The degree of methylation will be determined by measuring the amount of marker incorporated for each probe. The image intensities will be extracted using the Illumina Genome Studio 2011.1, Methylation module 1.9.0 software. The methylation score will be represented as a beta value (β) according to the fluorescence intensity ratio. Beta values can assume any value between 0 (unmethylated) and 1 (completely methylated). Subsequently, the image intensities will be extracted from the raw data (IDATS) using the Champ package for R (Statistical Computing, VIE, Austria). All genome-wide methylation data will be analyzed by t-test (within groups), followed by the Benjamini Hochberg test. Pathway enrichment analysis will be performed using WEBGestalt and Reactome. The normality of data distribution will be verified by the Shapiro Wilk test, and descriptive statistics will consist of mean and standard deviation values. ANOVA will be used to compare groups. Pearson correlations will be used to assess the correlation of DNA methylation patterns with phenotypic variables. Linear regression models will be applied to analyze the prediction of methylation pattern and selected variables. The multinomial logistic regression model will be used in the groups for association with telomere length adjusted for BMI, age, ALST). Statistical significance will be set at 5%, and all analyses will be performed using the Statistical Package for Social Sciences software (SPSS version 17.0 Inc. Chicago, IL).
- Conditions
- Sarcopenic Obesity, Sarcopenia, Obesity, Epigenesis, Genetic, Aging
- Being tested
- None (Observational Study)
- Keywords
- Sarcopenic Obesity, DNA Methylation, Aging
- Medical subject headings
- Sarcopenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational Study)Other
None (Observational Study)
| Study group | Role | What they receive |
|---|---|---|
| Healthy older women | Older women who do not have sarcopenia, obesity or sarcopenic obesity. Receives: Other: None (Observational Study) | |
| Older women with sarcopenia | Older women with sarcopenia, i.e. low handgrip strength and low muscle mass index. Receives: Other: None (Observational Study) | |
| Older women with obesity | Older women with obesity Receives: 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. Receives: Other: None (Observational Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start21 Feb 2024
- Primary completion5 Sep 2024
- Study completion5 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Ellen Cristini de Freitas, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618430
- Sponsor's protocol ID
- 73189623.6.0000.5659
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of DNA Methylation Pattern In Healthy, Sarcopenic, Obese And Sarcopenic Obese Older Women: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06618430
- Acronym / sponsor ID
- 73189623.6.0000.5659
- Conditions
- Sarcopenic Obesity, Sarcopenia, Obesity, Epigenesis, Genetic, Aging
- Keywords
- Sarcopenic Obesity, DNA Methylation, Aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Oct 2024 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The sample size was calculated a priori, considering DNA methylation as the primary outcome, on an exploratory basis. The analyses were conducted using R software (https://www.r-project.org). For the calculation, an effect size of 0.65, alpha 0.05 and statistical power of 0.80 were used. Thus, a total of 32 participants will be included in the study (n = 8 in each group). The degree of methylation will be determined by measuring the amount of marker incorporated for each probe. The image intensities will be extracted using the Illumina Genome Studio 2011.1, Methylation module 1.9.0 software. The methylation score will be represented as a beta value (β) according to the fluorescence intensity ratio. Beta values can assume any value between 0 (unmethylated) and 1 (completely methylated). Subsequently, the image intensities will be extracted from the raw data (IDATS) using the Champ package for R (Statistical Computing, VIE, Austria). All genome-wide methylation data will be analyzed by t-test (within groups), followed by the Benjamini Hochberg test. Pathway enrichment analysis will be performed using WEBGestalt and Reactome. The normality of data distribution will be verified by the Shapiro Wilk test, and descriptive statistics will consist of mean and standard deviation values. ANOVA will be used to compare groups. Pearson correlations will be used to assess the correlation of DNA methylation patterns with phenotypic variables. Linear regression models will be applied to analyze the prediction of methylation pattern and selected variables. The multinomial logistic regression model will be used in the groups for association with telomere length adjusted for BMI, age, ALST). Statistical significance will be set at 5%, and all analyses will be performed using the Statistical Package for Social Sciences software (SPSS version 17.0 Inc. Chicago, IL).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy older women | – | Other: None (Observational Study)Older women who do not have sarcopenia, obesity or sarcopenic obesity. |
| Older women with sarcopenia | – | Other: None (Observational Study)Older women with sarcopenia, i.e. low handgrip strength and low muscle mass index. |
| Older women with obesity | – | Other: None (Observational Study)Older women with obesity |
| Older women with sarcopenic obesity | – | Other: None (Observational Study)Older women with sarcopenic obesity, i.e. low handgrip strength, low muscle mass index and high body mass index. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- alcoholics;
- smokers;
- infectious diseases;
- coronary diseases;
- chronic kidney diseases and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational Study)None (Observational Study) | Other | Healthy older women, Older women with obesity, Older women with sarcopenia, Older women with sarcopenic obesity |
Primary outcome
Investigate whether the health condition (healthy, sarcopenic, obese or with sarcopenic obesity) promotes changes in DNA methylation
Time frame: 1 day
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenic Obesity and Sarcopenia, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate whether the health condition (healthy, sarcopenic, obese or with sarcopenic obesity) promotes changes in DNA methylation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.