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NCT Number: NCT06607068

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity and Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Escola de Educação Física e Esporte de Ribeirão Preto

Ribeirão Preto, São Paulo, 14040900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Have not exercised regularly for at least 3 months;

Exclusion criteria

  • 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

Treatment and study plan

None (Observational study)

Other

None (Observational study)

Primary outcomes

  1. Plasma taurine concentration

    Time frame: 1 day at baseline

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

Secondary outcomes

  1. Lipid Profile

    Time frame: 1 day at baseline

    Serum levels of HDL, total cholesterol and triglycerides will be assayed (mg/dL)

  2. Glycemic Profile

    Time frame: 1 day at baseline

    Serum levels of estimated average blood glucose (mg/dL)

  3. Glycated hemoglobin

    Time frame: 1 day at baseline

    Serum levels glycated hemoglobin (%)

  4. Macronutrients intake

    Time frame: 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

  5. Microminerals intake

    Time frame: 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

  6. Level of consumption of ultra-processed foods

    Time frame: 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.

  7. Upper limb strength endurance test: forearm flexion

    Time frame: 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.

  8. Sit-to-Stand-Test

    Time frame: 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.

  9. Lower limb muscle strength on an adjustable isokinetic dynamometer.

    Time frame: 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.

  10. Body fat percentage (%)

    Time frame: 1 day at baseline

    Using the total body scan from the Dual-energy X-ray absorptiometry (DXA), body fat percentage will be assessed

  11. Six-minute walk test

    Time frame: 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.

  12. Measurement of manual grip strength

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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