Status:
NOT_YET_RECRUITING
Evaluation of a Novel Self-Sampling Earwax Tool for Chronic Disease Biomarkers [TREARS STUDIES II]
Lead Sponsor:
Trears
Collaborating Sponsors:
Universidad del Desarrollo
Hospital Padre Hurtado
Conditions:
Metabolic Syndrome
Diabetes
Eligibility:
All Genders
18-75 years
Brief Summary
Trears Biomarkers: A New Way to Manage Chronic Diseases Trears Biomarkers are changing how we care for chronic diseases by focusing on patients' needs. People with chronic conditions often experience...
Detailed Description
Title The Validity of a Novel Diabetes Diagnostic Device and its Feasibility as Metabolic Syndrome Diagnostic One. \[TREARS STUDIES II\] Herane-Vives, Andres1,2,3 1. Visiting Lecturer; Institute of...
Eligibility Criteria
Inclusion
- \- i.People older than 35 years old ii.First-degree relative \[parents or siblings\] with diabetes. iii.Latin \[Chilean\] nationality iv.Women with a previous history of gestational diabetes or delivering a macrosomic (\>9lb) baby v.Overweight or obese \[BMI greater than or equal to 25 kg/m2\] vi.Physical inactivity (no work-, transport-, or recreation-related physical activity in a typical week) vii.BP ≥130 and/or ≥80 mm Hg or use of antihypertensive medication viii.Self-reported diagnosis of prediabetes IFG, IGT or borderline diabetes. ix.Self-reported history of CVD: myocardial infarction, coronary heart disease, or stroke.
- x.HDL-cholesterol \< 35 mg/dL, triglycerides \> 250 mg/dL, or lipid-lowering medication use xi.Women with polycystic ovarian syndrome xii.People with conditions associated with insulin resistance, such as acanthosis nigricansxiii.
- Have non-alcoholic fatty liver disease.
Exclusion
- Participants with any ear disease, including external or internal otitis; Meniere syndrome or any form of dizziness; vertigo; malformation of the external ear; tinnitus; impacted earwax; current or previously perforated eardrums; individuals with tubes in their ears or who have had mastoid surgery; hearing loss or deafness, due to excess earwax production.
- Asian ethnicity or intellectual disabilities due to their differences in the type and amount and type of earwax, respectively (Nussinovitch et al., 2004b; Pata et al., 2003).
- This study will exclude people with very high blood glucose (blood sugar) levels \[greater than or equal to 200 mg/dl\] or with classic symptoms of high blood glucose.
- Individuals with extreme ages under 18 years of age and over 75 years due to their different physiological responses and higher risk profiles.
- Any conditions that might result in a significant change in glycemia, such as diseases requiring steroid therapy or pregnancy plans during the study period, will be exclusionary.
- Any conditions that might result in a significant change in BP, such as diseases requiring steroid therapy or pregnancy plans during the study period, will be exclusionary.
- Any conditions that might result in a significant change in BMI, such as plans for pregnancy during the study period, will be exclusionary.
- Participants with hemoglobinopathies, anaemia, reticulocytosis, blood loss, transfusions, chronic renal or liver disease, high-dose vitamin C, or erythropoietin treatment (Nathan et al., 2007) will also be excluded (Nathan et al., 2007; Weatherall, 2011).
- Individuals with a phobia of needles
- Presence of infection or acute metabolic complications of diabetes, such as ketoacidosis or hyperosmolar state (coma).
- Individuals with existing cardiovascular conditions (e.g., coronary artery disease, heart failure, arrhythmias) may be at increased risk of adverse events (e.g., arrhythmias, hypertensive crises) during salt and fat loading.
- Individuals with morbid obesity (e.g., BMI \> 40 kg/m²) if not safely manageable within the study protocols.
- Current or heavy smokers, e.g. 20 or more cigarettes per day, due to the cardiovascular and metabolic impact of tobacco.
- Individuals who abuse alcohol or any illicit substance due to their potential impact on liver and kidney function, electrolyte balance, and blood pressure regulation.
- Participants adhering to strict dietary regimens (e.g., ketogenic diet, vegetarianism) may have atypical metabolic responses to high-fat and high-salt intake.
- Individuals with existing renal diseases, e.g. Chronic Kidney Disease (CKD) stages 3-5 (eGFR \<60 mL/min/1.73m²), history of acute kidney injury, nephrotic syndrome or significant proteinuria.
- Individuals with recent illness or hospitalisation.
- Current users of loop diuretics, thiazides, or potassium-sparing diuretics. insulin or oral hypoglycaemic agents, statins and other lipid-lowering drugs
- Individuals with polypharmacy will also be excluded, including steroids or any medication that may affect sodium secretion and/or excretion in tablets, creams, or aerosols.
- Allergy to medical grade adhesive or isopropyl alcohol used to prepare the skin.
- Presence of skin lesions, scarring, redness, infection, or oedema at sensor application sites.
- Individuals with Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis), history of bariatric surgery within the past year, severe malabsorption syndromes, hepatitis, type 1 or Type 2 Diabetes Mellitus requiring insulin therapy, hyperaldosteronism or Addison's disease, thyroid disorders (e.g.,hyperthyroidism, hypothyroidism) not adequately controlled.
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) regularly.
- The presence of any other condition is considered to warrant exclusion.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT06932601
Start Date
July 1 2025
End Date
July 1 2027
Last Update
April 17 2025
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