Identification of Biomarkers for the Study of the Diabetic Foot and Evolution.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-02

Study Completion Date

2024-01-07

Brief Summary

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The European Working Group on Sarcopenia in the Elderly1 defines sarcopenia as a disorder of the progressive and generalized musculoskeletal system \[1\], which is associated with the increase and probability of adverse outcomes including falls, fractures, physical disability, and mortality \[2\]. what is associated with increased and likelihood of adverse outcomes including falls, fractures, disability physical and mortality \[2\]. For a long time, sarcopenia was associated with aging, affecting onlyold people. At present and after several research works related to fragility and theaging, it has been identified that the development of sarcopenia begins earlier in life \[3\], and that there are many contributing causes besides aging \[4\], \[5\]. This new knowledge has implications in the intervention of sarcopenia that prevents or delays its development. Sarcopenia is currently considered a muscle disease (muscle failure), based on adverse changes in the muscles of the musculoskeletal system accumulated throughout life, with loss of muscle strength such as main determinant \[6\], \[7\]. Sarcopenia has been overlooked in clinical practice, apparently due to to the complexity in determining the variables to be measured, how to measure them, and the values or cut-off points can guide diagnosis and treatment, and how best to assess the effects of therapeutic intervention \[8\]. In terms economic, the presence of sarcopenia increases the risk of hospitalization and increases the cost of care during hospital admission \[9\]. Diabetes is the main cause of non-traumatic amputation of the lower limb (MI), being foot ulcers diabetic the cause of 80% of the amputations of people with diabetes\[10\]. A study conducted by the Chongqing University Hospital showed that sarcopenia is independently related to the foot diabetic and that patients with diabetic foot have a worse prognosis if they suffer from sarcopenia. HYPOTHESIS: The surface electromyography (EMGs) signal recording of the foot musculature, will allow extracting biomarkers that allow monitoring and follow-up of sarcopenia in diabetic patients.

MAIN OBJECTIVES: 1- Generate tools based on artificial intelligence (AI) using the database with the biomarkers obtained, in order to analyze the predisposing and triggering risk factors associated with diabetic foot ulcers, according to the IWGDF2. 2- Describe the profile of the diabetic patient in terms of degree of sarcopenia with respect to the population without diabetes in a group of adults. DESIGN: Observational study comparison between cases and controls: a group with the presence of Diabetes Mellitus and another without. SAMPLE: Approximately 16% of diabetic patients will develop an ulcer during their evolution and the Annual incidence is 2-3%, which doubles to 6% in the presence of polyneuropathy. Population of the Department of Health 168,978. Prevalence of diabetes in Spain 7.8%. It is estimated that there are 13,182 in the department people with diabetes. Confidence level 95%, expected frequency of ulcers 6% and confidence limit 9%, it was calculates the sample of 26 patients. 30 patients per group will be recruited. GROUP 1: 30 patients with Diabetes Mellitus. GROUP 2: 30 control patients without Diabetes Mellitus. The period of inclusion of patients is estimated at 5 months. METHOD: the assessment interventions will be carried out in two days. During the first visit, examination to identify risk to the foot: clinical history (PA, comorbidity data, previous injuries to the feet).

feet..), examination of the vascular state, examination of loss of protective sensitivity, perception of pressure, skin inspection, inspection of bone/joint structures, physical limitations and level of knowledge of the foot care. During the second visit: diagnostic tests for sarcopenia (bioimpedance and electromyography), arthropometric measurements, malnutrition, dependence and activity marker tests.

EXPECTED RESULTS: clarify some aspects related to the sarcopenia-diabetic foot binomial, and isolate risk factors for future prevention, by obtaining biomarkers with EMGs in lower limbs.

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Detailed Description

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The European Working Group on Sarcopenia in the Elderly3 defines sarcopenia as a disorder of the progressive and generalized musculoskeletal system \[1\], which is associated with the increase and probability of adverse outcomes including falls, fractures, physical disability, and mortality \[2\]. During For a long time, sarcopenia was associated with aging, affecting only older people. currently and After various research papers related to frailty and aging, it has been identified that the development of sarcopenia begins earlier in life \[3\], and that there are many contributing causes to it in addition to aging \[4\], \[5\]. This new knowledge has implications for the intervention of the sarcopenia that prevents or delays its development. Sarcopenia is currently considered a muscle disease (muscle failure), based on adverse changes in the muscles of the muscular system skeletal muscle accumulated throughout life, with loss of muscle strength as the main determinant \[6\], \[7\].

Sarcopenia has been overlooked in clinical practice, apparently due to the complexity in determining the variables to be measured, how to measure them, and the values or cut-off points can guide a diagnosis and its treatment, and how best to assess the effects of therapeutic intervention \[8\]. In economic terms, the presence of sarcopenia increases the risk of hospitalization and increases the cost of care during admission hospital \[9\]. Diabetes is the main cause of non-traumatic amputation of the lower limb (MI), being foot ulcers diabetic the cause of 80% of the amputations of people with diabetes\[10\]. A study conducted by the Chongqing University Hospital showed that sarcopenia is independently related to the foot diabetic and that patients with diabetic foot have a worse prognosis if they suffer from sarcopenia. The percentage of patients with sarcopenia in diabetic foot is more than double that in patients without diabetic foot disease (EPD) (35.3% vs. 16.4%, P\<0.001)\[11\]. The 5-year mortality rate in amputations of the MMI it is almost double in patients with sarcopenia than without sarcopenia (60.7% vs. 36.4%, P\<0.006). There are three causes of PDE, peripheral arterial disease (PAD), diabetic neuropathy, and infection, and here the importance that sarcopenia has in this problem appears, because it accelerates its evolution. Yes ok the reasons are not well known about this link, there is something that is known, and that is that both neuropathy as vascular disease are associated with sarcopenia. Drey et al showed in a cross-sectional study, older adults with sarcopenia are more likely to lose motor neurons than those without sarcopenia loss of muscle mass \[12\]. Prior and her team provided evidence that sarcopenia in the elderly is associated with less capillarization. The authors also found that patients with sarcopenia presented higher proportion of neuropathy and EPD. It is for all of the above that neuropathy and vascular lesions could associate sarcopenia with diabetic foot \[13\]. The molecular bases of EPD-associated sarcopenia have not been clearly identified. However, it is known that the myokines and myometabolites that are normally released by muscle to connect with other organs and promote health, are altered. there is even knowledge evidence that a sarcopenic muscle has an overproduction of free radicals of oxygen (ROS) and nitrogen, something that is claimed to mediate neuropathy and vascular lesions, all of which could show the link between sarcopenia and EPD. So then, if it is indeed ensured that the loss of muscle mass is related to EPD, treating sarcopenia and its prevention, could be important for the prevention of the lesions

Conditions

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Diabetes Mellitus Diabetic Foot Sarcopenia Neuropathy, Diabetic Vascular Disease, Peripheral Metabolic Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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DIABETIC

PERFORMANCE OF BIOIMPEDANCIOMETRY WITH DETERMINATION OF:

* Daily calorie intake
* Body fat mass and percentage
* Segmental body fat percentage
* Resting Heart Rate
* Lean Mass
* Risk of sarcopenia
* Proteins
* Extra Cellular Water
* Intracellular Water
* Phase Angle
* Visceral fat
* Muscle mass
* Segmental muscle mass
* Muscle quality score
* Total body water (%)
* Metabolic age

BIOIMPEDANCEMETRY

Intervention Type DIAGNOSTIC_TEST

The impedance of cellular tissue can be modeled as a resistor (representing the extracellular path) in parallel with a resistor and capacitor in series (representing the intracellular path, the resistance that of intracellular fluid and the capacitor the cell membrane). This results in a change in impedance versus the frequency used in the measurement. Whole body impedance measurement is generally measured from the wrist to the ipsilateral ankle and uses either two (rarely) or four (overwhelmingly) electrodes. In the 2-elctrode (bipolar) configuration a small current on the order of 1-10 μA is passed between two electrodes, and the voltage is measured between the same whereas in the tetrapolar arrangement resistance is measured between as separate pair of proximally located electrodes. The tetrapolar arrangement is preferred since measurement is not confounded by the impedance of the skin-electrode interface

Interventions

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BIOIMPEDANCEMETRY

The impedance of cellular tissue can be modeled as a resistor (representing the extracellular path) in parallel with a resistor and capacitor in series (representing the intracellular path, the resistance that of intracellular fluid and the capacitor the cell membrane). This results in a change in impedance versus the frequency used in the measurement. Whole body impedance measurement is generally measured from the wrist to the ipsilateral ankle and uses either two (rarely) or four (overwhelmingly) electrodes. In the 2-elctrode (bipolar) configuration a small current on the order of 1-10 μA is passed between two electrodes, and the voltage is measured between the same whereas in the tetrapolar arrangement resistance is measured between as separate pair of proximally located electrodes. The tetrapolar arrangement is preferred since measurement is not confounded by the impedance of the skin-electrode interface

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. The sample will include all the people who sign the informed consent.
2. Patients aged between 18 and 80 years.
3. Patients diagnosed with Type 2 Diabetes Mellitus (more than 5 years from diagnosis), who continue to be monitored in the diabetes nursing office of the Health Department of the General Hospital of Elche.
4. Patients with Risk Level 0, Risk 1 and 2 according to the International Working Group on the Diabetic Foot -IWGDF.
5. Patient with control analysis, a maximum of one month prior to inclusion.

Exclusion Criteria

1. People who do not give their consent to participate in the study.
2. Participants excluded for having problems walking (they used a cane or walker and/or had disabilities to stand up on their own)
3. Patients who have previously had treatment with plantar orthoses

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No