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

NCT06607068 | Active Not Recruiting

• 2 other identifiers: 75476423.4.0000.56592023/15008-9
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity and Type 2 Diabetes

Keywords

diabetes mellitus; obesity; aging; taurine; oxidative stress

Outcome Measures

Primary Outcomes (1)

• Plasma taurine concentration

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

  1 day at baseline

Secondary Outcomes (12)

• 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

Study Arms (4)

GIObDM - Older women with obesity and type 2 diabetes mellitus

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)

Other: None (Observational study)

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

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)

Other: None (Observational study)

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

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.

Other: None (Observational study)

GIEut - Eutrophic older women

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.

Other: None (Observational study)

Interventions

None (Observational study) OTHER

None (Observational study)

GIDM - Older women without obesity and with type 2 diabetes mellitus; GIEut - Eutrophic older women; GIOb - Older women with obesity and without type 2 diabetes mellitus; GIObDM - Older women with obesity and type 2 diabetes mellitus

Eligibility Criteria

• Age: 60 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Have not exercised regularly for at least 3 months;

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Escola de Educação Física e Esporte de Ribeirão Preto

Ribeirão Preto, São Paulo, 14040900, Brazil

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected in the morning, after 12 hours of fasting, by experienced nurses. 5 ml of blood will be collected for analysis of biochemical markers (after centrifugation and separation of plasma/serum, they will be stored in a freezer at -80°C for analysis). The evaluation of biochemical markers will involve the quantification of insulin sensitivity, glycemia, HbA1c, total cholesterol, insulin, triglycerides and HDL cholesterol. The kits Liquiform Total Cholesterol, HDL Cholesterol, Liquiform Triglycerides and Liquiform Glucose from Labtest diagnóstica® will be used, using an enzymatic system and absorbance spectrophotometer.

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Observation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Adelino Sanchez Ramos da Silva, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: February 28, 2024
• Primary Completion: September 5, 2024
• Study Completion: January 30, 2026
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)