Assessment of Taurine Concentration in Older Women With/Without Obesity And With/Without Type 2 Diabetes Mellitus

September 20, 2024 updated by: Adelino Sanchez Ramos da Silva, University of Sao Paulo

Assessment of Taurine Concentration in Older Women With/Without Obesity And With/Without Type 2 Diabetes Mellitus: a Cross-Sectional Study

Aging is a multifactorial process marked by several epigenetic and molecular changes, such as telomere shortening, DNA exposure to damage, mitochondrial dysfunction, accumulation of senescent cells, and oxidative stress. Such changes lead to the degeneration of cells and molecules, which affects tissues, organs, and systems over time, reducing the human body's ability to resist damage and favoring the development of chronic diseases such as Type 2 Diabetes Mellitus (T2DM). Taurine, a semi-essential amino acid, appears to be related to oxidative homeostasis, glucose control, and inflammation. Therefore, knowing the plasma concentrations of this amino acid in different populations is necessary to obtain a better understanding of the role of taurine in the pathophysiology of obesity and T2DM in older population, in addition to generating hypotheses regarding interventions capable of attenuating oxidative stress and inflammation, which are important hallmarks of aging.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study is to investigate whether health status (women with obesity, T2DM and no comorbidities) promotes changes in plasma taurine concentration and to correlate this concentration with biochemical markers (e.g. blood glucose, total cholesterol, insulin, glycated hemoglobin, triglycerides and HDL cholesterol). As well as to evaluate and compare the physical capacities of the different groups. Methods: Forty older women will participate in the cross-sectional study and will be allocated into four distinct groups, and will be classified as follows: older women with obesity and T2DM, older women with obesity and no T2DM, older women without obesity and with T2DM; eutrophic older women, with 10 older women in each group. The following will be performed: body composition assessment by total and regional body scanning using iDXA, anthropometry, tests to assess physical performance, peripheral blood collection for analysis of biochemical markers and the Physical Activity Level will be assessed using the Modified Baecke Questionnaire for Olders. For statistical analysis, One-way ANOVA will be used to verify the differences and compare the four groups. Expected results: It is expected that older women with obesity and T2DM will have lower plasma taurine concentration and also lower performance in physical tests, compared to the other groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Ribeirão Preto, SP, Brazil, 14040900
        • Escola de Educação Física e Esporte de Ribeirão Preto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The sample will consist of 40 elderly women who will be allocated into four distinct groups with 10 elderly women in each group.

Description

Inclusion Criteria:

Have not exercised regularly for at least 3 months;

Exclusion Criteria:

  1. use of insulin;
  2. consumption of multivitamin supplements or antioxidant vitamins;
  3. consumption of mineral supplements such as Copper, Zinc and/or Manganese;
  4. liver disease;
  5. chronic kidney disease;
  6. coronary disease;
  7. thyroid disorders;
  8. infectious diseases;
  9. regular consumption of alcoholic beverages;
  10. smoking;
  11. the Mini Mental State Examination (MMSE) will be applied, which has a total score ranging from 0-30 points. For the elderly women to be included in the study, they must have a score greater than or equal to 13 points

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
GIObDM - Older women with obesity and type 2 diabetes mellitus
Obesity will be assessed using the Body Mass Index (BMI), with older women being considered obese if they have a BMI above 30 km/m² (OPAS, 2002)
Other: None (Observational study)
None (Observational study)
GIOb - Older women with obesity and without type 2 diabetes mellitus
Obesity will be assessed using the Body Mass Index (BMI), with elderly women being considered obese if they have a BMI above 30 km/m² (OPAS, 2002)
Other: None (Observational study)
None (Observational study)
GIDM - Older women without obesity and with type 2 diabetes mellitus
The groups with DM2 will include elderly women who have already been medically diagnosed with DM2 , have been using a hypoglycemic/antidiabetic medication for at least 6 months and have fasting blood glucose ≥ 126mg/dL and/or HbA1c ≥ 6.5% in a blood test in the last 6 months.
Other: None (Observational study)
None (Observational study)
GIEut - Eutrophic older women
For the group of eutrophic older women, they must have a BMI ≥ 23 and ≤ 28 kg/m² (OPAS, 2002). The medications used by all participants will be surveyed, as well as their dosages and daily consumption.
Other: None (Observational study)
None (Observational study)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma taurine concentration
Time Frame: 1 day at baseline
Collected in EDTA tubes, were centrifuged and the plasma taurine concentration was evaluated using HPLC (high performance liquid chromatography).
1 day at baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lipid Profile
Time Frame: 1 day at baseline
Serum levels of HDL, total cholesterol and triglycerides will be assayed (mg/dL)
1 day at baseline
Glycemic Profile
Time Frame: 1 day at baseline
Serum levels of estimated average blood glucose (mg/dL)
1 day at baseline
Glycated hemoglobin
Time Frame: 1 day at baseline
Serum levels glycated hemoglobin (%)
1 day at baseline
Macronutrients intake
Time Frame: 1 day at baseline
The participants dietary intake will be assessed using a three-day dietary recall. The records must be completed by the participants on two weekdays and one weekend day. The professional Dietbox software will be used to calculate the caloric intake of macronutrients
1 day at baseline
Microminerals intake
Time Frame: 1 day at baseline
The participants dietary intake will be assessed using a food registry of 3 days. The records must be completed by the participants on two weekdays and one weekend day. The professional Dietbox software will be used to calculate the caloric intake of microminerals
1 day at baseline
Level of consumption of ultra-processed foods
Time Frame: 1 day at baseline
This study will evaluate the level of consumption of ultra-processed foods. The NOVA classification will be used for this purpose.
1 day at baseline
Upper limb strength endurance test: forearm flexion
Time Frame: 1 day at baseline
Upper limb strength endurance test: forearm flexion for 30 seconds; To assess the strength endurance of the upper limbs, the forearm flexion test will be applied. The number of repetitions in 30 seconds will be counted.
1 day at baseline
Sit-to-Stand-Test
Time Frame: 1 day at baseline
Sit-to-Stand-Test (30 seconds). This test will be used to quantify the lower limb strength of older women, and is recommended in the literature for this population. The number of repetitions in 30 seconds will be counted.
1 day at baseline
Lower limb muscle strength on an adjustable isokinetic dynamometer.
Time Frame: 1 day at baseline
The angular velocities that will be used in the test will be 60º/s. A series of ten repetitions will be performed for the dominant limb for familiarization, followed by a 3-minute rest.
1 day at baseline
Body fat percentage (%)
Time Frame: 1 day at baseline
Using the total body scan from the Dual-energy X-ray absorptiometry (DXA), body fat percentage will be assessed
1 day at baseline
Six-minute walk test
Time Frame: 1 day at baseline
This test aims to assess aerobic capacity. The 6-minute walk test uses a 45.7 m total rectangular path: 18.28 m long by 4.57 m wide. The participant will be instructed to walk as fast as possible (without running) during the 6 minutes, as many times as they can in the rectangle. At the end of the time, the evaluator will record the total distance covered by the participant in meters.
1 day at baseline
Measurement of manual grip strength
Time Frame: 1 day at baseline
The older woman's forearm should be positioned in half pronation, with the wrist in a neutral position. The hand should be positioned on the dynamometer, which will be held by the evaluator. Three attempts will be made with the dominant hand, with 3 seconds of grip and one-minute intervals between them. Of the three attempts, the one with the highest peak force (the largest measurement) will be recorded, in kilograms of force.
1 day at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adelino Sanchez Ramos da Silva, PhD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 75476423.4.0000.5659
  • 2023/15008-9 (Other Grant/Funding Number: Fundação de Amparo à Pesquisa do Estado de São Paulo)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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