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

NCT ID: NCT06607068

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-28
• Study Completion Date: 2026-01-30

Brief Summary

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.

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.

Conditions

Obesity and Type 2 Diabetes

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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)

None (Observational study)

Intervention Type: OTHER

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)

None (Observational study)

Intervention Type: OTHER

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.

None (Observational study)

Intervention Type: OTHER

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.

None (Observational study)

Intervention Type: OTHER

None (Observational study)

Interventions

None (Observational study)

None (Observational study)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Adelino Sanchez Ramos da Silva

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adelino Sanchez Ramos da Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Escola de Educação Física e Esporte de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

2023/15008-9

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

75476423.4.0000.5659

Identifier Type: -

Identifier Source: org_study_id