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

NCT05783700 | Unknown DMC

• 1 other identifier: PI 138/2022
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

DIABETES MELLITUS; DIABETIC FOOT; SARCOPENIA; NEUROPATHY, DIABETIC; VASCULAR DISEASE, PERIPHERAL

Outcome Measures

Primary Outcomes (1)

• BIOIMPEDANCEMETRY

  Bioelectrical impedance analysis (BIA) is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Most body water is stored in muscle. Therefore, if a person is more muscular there is a high chance that the person will also have more body water, which leads to lower impedance. Since the advent of the first commercially available devices in the mid-1980s the method has become popular owing to its ease of use and portability of the equipment. It is familiar in the consumer market as a simple instrument for estimating body fat. BIA\[1\] actually determines the electrical impedance, or opposition to the flow of an electric current through body tissues which can then be used to estimate total body water (TBW), which can be used to estimate fat-free body mass and, by difference with body weight, body fat.

  FIFTEEN MINUTES

Secondary Outcomes (11)

• Body fat mass and percentage

  ONLY ONCE. 10 MINUTES

• Segmental body fat percentage

  ONLY ONCE. 10 MINUTES

• Visceral fat

  ONLY ONCE. 10 MINUTES

• Muscle mass

  ONLY ONCE. 10 MINUTES

• Muscle quality score

  ONLY ONCE. 10 MINUTES

Study Arms (1)

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

Diagnostic Test: BIOIMPEDANCEMETRY

Interventions

BIOIMPEDANCEMETRY 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

DIABETIC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• The sample will include all the people who sign the informed consent.
• Patients aged between 18 and 80 years.
• 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.
• Patients with Risk Level 0, Risk 1 and 2 according to the International Working Group on the Diabetic Foot -IWGDF.

You may not qualify if:

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

Sponsors & Collaborators

• Esther Soler: lead

Related Publications (9)

• Sayer AA, Syddall HE, Dennison EM, Gilbody HJ, Duggleby SL, Cooper C, Barker DJ, Phillips DI. Birth weight, weight at 1 y of age, and body composition in older men: findings from the Hertfordshire Cohort Study. Am J Clin Nutr. 2004 Jul;80(1):199-203. doi: 10.1093/ajcn/80.1.199.

  PMID: 15213049 BACKGROUND

• Kim YK, Lee HS, Ryu JJ, In Lee H, Seo SG. Sarcopenia increases the risk for mortality in patients who undergo amputation for diabetic foot. J Foot Ankle Res. 2018 Jun 19;11:32. doi: 10.1186/s13047-018-0274-1. eCollection 2018.

  PMID: 29946364 BACKGROUND

• Jimenez S, Rubio JA, Alvarez J, Ruiz-Grande F, Medina C. Trends in the incidence of lower limb amputation after implementation of a Multidisciplinary Diabetic Foot Unit. Endocrinol Diabetes Nutr. 2017 Apr;64(4):188-197. doi: 10.1016/j.endinu.2017.02.009. Epub 2017 Mar 30. English, Spanish.

  PMID: 28417873 BACKGROUND

• Li Y, Guo C, Cao Y. Secular incidence trends and effect of population aging on mortality due to type 1 and type 2 diabetes mellitus in China from 1990 to 2019: findings from the Global Burden of Disease Study 2019. BMJ Open Diabetes Res Care. 2021 Nov;9(2):e002529. doi: 10.1136/bmjdrc-2021-002529.

  PMID: 34732399 RESULT

• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

  PMID: 30312372 RESULT

• Buckinx F, Landi F, Cesari M, Fielding RA, Visser M, Engelke K, Maggi S, Dennison E, Al-Daghri NM, Allepaerts S, Bauer J, Bautmans I, Brandi ML, Bruyere O, Cederholm T, Cerreta F, Cherubini A, Cooper C, Cruz-Jentoft A, McCloskey E, Dawson-Hughes B, Kaufman JM, Laslop A, Petermans J, Reginster JY, Rizzoli R, Robinson S, Rolland Y, Rueda R, Vellas B, Kanis JA. Pitfalls in the measurement of muscle mass: a need for a reference standard. J Cachexia Sarcopenia Muscle. 2018 Apr;9(2):269-278. doi: 10.1002/jcsm.12268. Epub 2018 Jan 19.

  PMID: 29349935 RESULT

• 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.

  PMID: 24442632 RESULT

• Han A, Bokshan SL, Marcaccio SE, DePasse JM, Daniels AH. Diagnostic Criteria and Clinical Outcomes in Sarcopenia Research: A Literature Review. J Clin Med. 2018 Apr 8;7(4):70. doi: 10.3390/jcm7040070.

  PMID: 29642478 RESULT

• 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.

  PMID: 26888434 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot; Sarcopenia; Diabetic Neuropathies; Peripheral Vascular Diseases; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Insulin Resistance; Hyperinsulinism

Central Study Contacts

ESTHER SOLER, BSN

CONTACT

966 61 69 00; soler_estcli@gva.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Bachelor of Science in Nursing

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: October 2, 2023
• Primary Completion: December 4, 2023
• Study Completion: January 7, 2024
• Last Updated: March 27, 2023

Record last verified: 2023-03