Clinical trial NCT05783700: Identification of Biomarkers for the Study of the Diabetic Foot and Evolution.
Official title: Identification of Biomarkers for the Study of Sarcopenia and Its Evolution in Diabetic Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Diabetic Foot
Sarcopenia
Neuropathy, Diabetic
Vascular Disease, Peripheral
Metabolic Syndrome
Keywords: DIABETES MELLITUS
DIABETIC FOOT
SARCOPENIA
NEUROPATHY, DIABETIC
VASCULAR DISEASE, PERIPHERAL
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients assisted at the San Fermín Specialty Center of the Elche General Hospital Health Department, with and without Type 2 Diabetes Mellitus.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: BIOIMPEDANCEMETRY
timeFrame: FIFTEEN MINUTES
Secondary outcomes:
measure: Body fat mass and percentage
timeFrame: ONLY ONCE. 10 MINUTES
measure: Segmental body fat percentage
timeFrame: ONLY ONCE. 10 MINUTES
measure: Visceral fat
timeFrame: ONLY ONCE. 10 MINUTES
measure: Muscle mass
timeFrame: ONLY ONCE. 10 MINUTES
measure: Muscle quality score
timeFrame: ONLY ONCE. 10 MINUTES
measure: Total body water (%)
timeFrame: ONLY ONCE. 10 MINUTES
measure: Bone mass
timeFrame: ONLY ONCE. 10 MINUTES
measure: ONLY ONCE. 10 MINUTES
timeFrame: ONLY ONCE. 10 MINUTES
measure: Body Mass Index
timeFrame: ONLY ONCE. 10 MINUTES
measure: Daily calorie intake (DCI)
timeFrame: ONLY ONCE. 10 MINUTES
measure: Resting heart rate
timeFrame: ONLY ONCE. 10 MINUTES
Other outcomes:
Locations:
Study officials:
References:
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citation: Trevino-Aguirre E, Lopez-Teros T, Gutierrez-Robledo L, Vandewoude M, Perez-Zepeda M. Availability and use of dual energy X-ray absorptiometry (DXA) and bio-impedance analysis (BIA) for the evaluation of sarcopenia by Belgian and Latin American geriatricians. J Cachexia Sarcopenia Muscle. 2014 Mar;5(1):79-81. doi: 10.1007/s13539-013-0126-6. Epub 2014 Jan 18. No abstract available.
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citation: Prior SJ, Ryan AS, Blumenthal JB, Watson JM, Katzel LI, Goldberg AP. Sarcopenia Is Associated With Lower Skeletal Muscle Capillarization and Exercise Capacity in Older Adults. J Gerontol A Biol Sci Med Sci. 2016 Aug;71(8):1096-101. doi: 10.1093/gerona/glw017. Epub 2016 Feb 17.