Assessment of Taurine Concentration in Older Women With/Without Obesity And With/Without Type 2 Diabetes Mellitus
- Conditions
- Obesity and Type 2 Diabetes
- Interventions
- Other: None (Observational study)
- Registration Number
- NCT06607068
- Lead Sponsor
- University of Sao Paulo
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 40
Have not exercised regularly for at least 3 months;
- use of insulin;
- consumption of multivitamin supplements or antioxidant vitamins;
- consumption of mineral supplements such as Copper, Zinc and/or Manganese;
- liver disease;
- chronic kidney disease;
- coronary disease;
- thyroid disorders;
- infectious diseases;
- regular consumption of alcoholic beverages;
- smoking;
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description GIObDM - Older women with obesity and type 2 diabetes mellitus None (Observational study) 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) GIOb - Older women with obesity and without type 2 diabetes mellitus None (Observational study) 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) GIDM - Older women without obesity and with type 2 diabetes mellitus None (Observational study) 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. GIEut - Eutrophic older women None (Observational study) 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.
- Primary Outcome Measures
Name Time Method Plasma taurine concentration 1 day at baseline Collected in EDTA tubes, were centrifuged and the plasma taurine concentration was evaluated using HPLC (high performance liquid chromatography).
- Secondary Outcome Measures
Name Time Method Lipid Profile 1 day at baseline Serum levels of HDL, total cholesterol and triglycerides will be assayed (mg/dL)
Glycemic Profile 1 day at baseline Serum levels of estimated average blood glucose (mg/dL)
Glycated hemoglobin 1 day at baseline Serum levels glycated hemoglobin (%)
Macronutrients intake 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
Microminerals intake 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
Level of consumption of ultra-processed foods 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.
Upper limb strength endurance test: forearm flexion 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.
Sit-to-Stand-Test 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.
Lower limb muscle strength on an adjustable isokinetic dynamometer. 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.
Body fat percentage (%) 1 day at baseline Using the total body scan from the Dual-energy X-ray absorptiometry (DXA), body fat percentage will be assessed
Six-minute walk test 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.
Measurement of manual grip strength 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.
Trial Locations
- Locations (1)
Escola de Educação Física e Esporte de Ribeirão Preto
🇧🇷Ribeirão Preto, SP, Brazil