Obesity and Type 2 DiabetesNCT06607068
Assessment of Taurine Concentration in Older Women With/Without Obesity And With/Without Type 2 Diabetes Mellitus
An observational study of Obesity and Type 2 Diabetes, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity and Type 2 Diabetes
- What is being tested?
- None (Observational study)
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Feb 2024to 30 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Have not exercised regularly for at least 3 months;
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola de Educação Física e Esporte de Ribeirão Preto
Ribeirão Preto, São Paulo, 14040900
About this study
Official title: Assessment of Taurine Concentration in Older Women With/Without Obesity And With/Without Type 2 Diabetes Mellitus: a Cross-Sectional Study
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.
Read the 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.
- Conditions
- Obesity and Type 2 Diabetes
- Being tested
- None (Observational study)
- Keywords
- diabetes mellitus, obesity, aging, taurine, oxidative stress
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational study)Other
None (Observational study)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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. Receives: 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. Receives: Other: None (Observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma taurine concentration
Collected in EDTA tubes, were centrifuged and the plasma taurine concentration was evaluated using HPLC (high performance liquid chromatography).
Measured: 1 day at baseline
Secondary outcomes (12)
Lipid Profile
Serum levels of HDL, total cholesterol and triglycerides will be assayed (mg/dL)
Measured: 1 day at baseline
Glycemic Profile
Serum levels of estimated average blood glucose (mg/dL)
Measured: 1 day at baseline
Glycated hemoglobin
Serum levels glycated hemoglobin (%)
Measured: 1 day at baseline
Macronutrients intake
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
Measured: 1 day at baseline
Microminerals intake
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
Measured: 1 day at baseline
Level of consumption of ultra-processed foods
This study will evaluate the level of consumption of ultra-processed foods. The NOVA classification will be used for this purpose.
Measured: 1 day at baseline
Upper limb strength endurance test: forearm flexion
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.
Measured: 1 day at baseline
Sit-to-Stand-Test
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.
Measured: 1 day at baseline
Lower limb muscle strength on an adjustable isokinetic dynamometer.
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.
Measured: 1 day at baseline
Body fat percentage (%)
Using the total body scan from the Dual-energy X-ray absorptiometry (DXA), body fat percentage will be assessed
Measured: 1 day at baseline
Six-minute walk test
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.
Measured: 1 day at baseline
Measurement of manual grip strength
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.
Measured: 1 day at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start28 Feb 2024
- Primary completion5 Sep 2024
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Adelino Sanchez Ramos da Silva, University of Sao Paulo
- Investigators
- Adelino Sanchez Ramos da Silva, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607068
- Sponsor's protocol ID
- 75476423.4.0000.5659
- Other IDs
- 2023/15008-9, 2023
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Taurine Concentration in Older Women With/Without Obesity And With/Without Type 2 Diabetes Mellitus: a Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06607068
- Acronym / sponsor ID
- 75476423.4.0000.5659
- Conditions
- Obesity and Type 2 Diabetes
- Keywords
- diabetes mellitus, obesity, aging, taurine, oxidative stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GIObDM - Older women with obesity and type 2 diabetes mellitus | – | Other: 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 | – | Other: 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 | – | Other: 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 | – | Other: 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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Have not exercised regularly for at least 3 months;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational study)None (Observational study) | Other | 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 |
Primary outcome
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).
12 secondary outcomes
Lipid Profile
Time frame: 1 day at baseline
Glycemic Profile
Time frame: 1 day at baseline
Glycated hemoglobin
Time frame: 1 day at baseline
Macronutrients intake
Time frame: 1 day at baseline
Microminerals intake
Time frame: 1 day at baseline
Level of consumption of ultra-processed foods
Time frame: 1 day at baseline
Upper limb strength endurance test: forearm flexion
Time frame: 1 day at baseline
Sit-to-Stand-Test
Time frame: 1 day at baseline
Lower limb muscle strength on an adjustable isokinetic dynamometer.
Time frame: 1 day at baseline
Body fat percentage (%)
Time frame: 1 day at baseline
Six-minute walk test
Time frame: 1 day at baseline
Measurement of manual grip strength
Time frame: 1 day at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adelino Sanchez Ramos da Silva, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Type 2 Diabetes, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma taurine concentration (time frame: 1 day at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.