Clinical trial NCT06607068: Assessment of Taurine Concentration in Older Women With/Without Obesity And With/Without Type 2 Diabetes Mellitus
Official title: Assessment of Taurine Concentration in Older Women With/Without Obesity And With/Without Type 2 Diabetes Mellitus: a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity and Type 2 Diabetes
Keywords: diabetes mellitus
obesity
aging
taurine
oxidative stress
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2024-09-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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\&#39;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.

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

Primary outcomes:
measure: Plasma taurine concentration
timeFrame: 1 day at baseline
Secondary outcomes:
measure: Lipid Profile
timeFrame: 1 day at baseline
measure: Glycemic Profile
timeFrame: 1 day at baseline
measure: Glycated hemoglobin
timeFrame: 1 day at baseline
measure: Macronutrients intake
timeFrame: 1 day at baseline
measure: Microminerals intake
timeFrame: 1 day at baseline
measure: Level of consumption of ultra-processed foods
timeFrame: 1 day at baseline
measure: Upper limb strength endurance test: forearm flexion
timeFrame: 1 day at baseline
measure: Sit-to-Stand-Test
timeFrame: 1 day at baseline
measure: Lower limb muscle strength on an adjustable isokinetic dynamometer.
timeFrame: 1 day at baseline
measure: Body fat percentage (%)
timeFrame: 1 day at baseline
measure: Six-minute walk test
timeFrame: 1 day at baseline
measure: Measurement of manual grip strength
timeFrame: 1 day at baseline
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Escola de Educação Física e Esporte de Ribeirão Preto
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Adelino Sanchez Ramos da Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References: