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

University of Sao Paulo

Status: Active, not recruiting

Conditions: Obesity and Type 2 Diabetes

Treatments: Other: None (Observational study)

Study type: Observational

Funder types: Other

Identifiers

NCT06607068

75476423.4.0000.5659

2023/15008-9 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 4 patient groups

GIObDM - Older women with obesity and type 2 diabetes mellitus

Description:

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)

Treatment:

Other: None (Observational study)

GIOb - Older women with obesity and without type 2 diabetes mellitus

Description:

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)

Treatment:

Other: None (Observational study)

GIDM - Older women without obesity and with type 2 diabetes mellitus

Description:

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.

Treatment:

Other: None (Observational study)

GIEut - Eutrophic older women

Description:

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.

Treatment:

Other: None (Observational study)