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临床试验/NCT06607068
NCT06607068进行中(未招募)不适用

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

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Plasma taurine concentration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Have not exercised regularly for at least 3 months;

排除标准

  • 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;
  • 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

结局指标

主要结局

Plasma taurine concentration

时间窗: 1 day at baseline

Collected in EDTA tubes, were centrifuged and the plasma taurine concentration was evaluated using HPLC (high performance liquid chromatography).

次要结局

  • Lipid Profile(1 day at baseline)
  • Glycemic Profile(1 day at baseline)
  • Glycated hemoglobin(1 day at baseline)
  • Macronutrients intake(1 day at baseline)
  • Microminerals intake(1 day at baseline)
  • Level of consumption of ultra-processed foods(1 day at baseline)
  • Upper limb strength endurance test: forearm flexion(1 day at baseline)
  • Sit-to-Stand-Test(1 day at baseline)
  • Lower limb muscle strength on an adjustable isokinetic dynamometer.(1 day at baseline)
  • Body fat percentage (%)(1 day at baseline)
  • Six-minute walk test(1 day at baseline)
  • Measurement of manual grip strength(1 day at baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adelino Sanchez Ramos da Silva

PhD

University of Sao Paulo

研究点 (1)

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