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Набор скоро начнётся NCT07518433

Study on Serum Transcriptomics and Metabolomics in Patients With Diabetic Peripheral Neuropathy

— Наблюдательное Diabetic Peripheral Neuropathy (DPN) Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Not applicable- observational study.
Кому может быть актуально
Состояния в реестре: Diabetic Peripheral Neuropathy (DPN), Pain. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This part of the study enrolled 30 sex- and age-matched healthy controls, 30 diabetic patients without peripheral neuropathy, and 30 patients with diabetic peripheral neuropathy (DPN). Blood samples were collected from the participants, and serum was isolated for transcriptomics and untargeted metabolomics analysis using liquid chromatography-mass spectrometry (LC-MS) to characterize the metabolic profile of DPN. Through differential comparison analysis, serum biomarkers associated with DPN were identified and further correlated with clinical parameters. This approach aims to establish early diagnostic markers for DPN and provide scientific evidence for understanding the complex mechanisms underlying DPN, thereby offering new insights into potential therapeutic strategies.

Вмешательства

  • Другое Not applicable- observational study
    Not applicable- observational study

Первичные конечные точки

  • Biospecimen Collection [Срок оценки: from month 0 to month 14]
Вторичные конечные точки (12)
  • Toronto Clinical Scoring System [Срок оценки: from month 0 to month 14]
  • Neurological Physical Examination [Срок оценки: from month 0 to month 14]
  • Michigan Neuropathy Screening Instrument (MNSI) [Срок оценки: from month 0 to month 14]
  • Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN) [Срок оценки: from month 0 to month 14]
  • Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) [Срок оценки: from month 0 to month 14]
  • Neuropathic Pain 4 Questions (DN4) [Срок оценки: from month 0 to month 14]
  • Visual Analogue Scale (VAS) [Срок оценки: from month 0 to month 14]
  • Electrophysiological examination of the peroneal nerve of the lower limb [Срок оценки: from month 0 to month 14]
  • Electrophysiological examination of the tibial nerve of the lower limb [Срок оценки: from month 0 to month 14]
  • White Blood Cell Count (WBC) [Срок оценки: from month 0 to month 14]
  • Red Blood Cell Count (RBC) [Срок оценки: from month 0 to month 14]
  • Hemoglobin [Срок оценки: from month 0 to month 14]

Критерии участия

Критерии включения

  • Patients diagnosed with diabetes mellitus (type 1 or type 2)
  • For the diabetic peripheral neuropathy (DPN) group: meet diagnostic criteria for painful diabetic peripheral neuropathy (P-DPN), defined as persistent pain and/or paresthesia in both lower limbs, with at least one objective sign of neuropathy (reduced ankle reflex, reduced vibration perception, or abnormal nerve conduction velocity when available), and a DN4 score ≥ 4
  • For the diabetic control (DC) group: patients with diabetes mellitus but no evidence of peripheral neuropathy
  • For the healthy control (HC) group: healthy volunteers without diabetes or neuropathy, matched for sex and age
  • Aged between 18 and 80 years (inclusive)
  • Able to perform activities of daily living independently and cooperate with study procedures
  • No severe cardiac, cerebral, hepatic, renal, or other systemic diseases, and no severe mental illness or cognitive impairment
  • Willing to participate and provide written informed consent

Критерии исключения

  • Peripheral neuropathy caused by factors other than diabetes, including but not limited to hypothyroidism, alcohol abuse, medications, genetic disorders, or other systemic diseases
  • Presence of limb ulcers, gangrene, or a history of skin ulceration or non-healing wounds
  • Acute diabetic complications such as diabetic ketoacidosis, hyperosmolar hyperglycemic state, lactic acidosis, or severe infections within the past 3 months
  • Severe hepatic or renal impairment, or severe cardiovascular or cerebrovascular diseases (e.g., unstable angina, myocardial infarction, multiple cerebral infarctions, cerebral hemorrhage)
  • Scars or hyperpigmentation at the testing site that may interfere with accurate measurements
  • Pregnancy, breastfeeding, or planned pregnancy during the study period
  • Participation in another interventional clinical trial within 3 months prior to screening
  • For the diabetic control (DC) group: presence of peripheral neuropathy
  • For the healthy control (HC) group: history of diabetes mellitus, peripheral neuropathy, or use of medications affecting neurological function

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • The Third Affiliated Hospital of Zhejiang Chinese Medical University — Ханчжоу

Идентификаторы

NCT: NCT07518433 · 20251215064859996

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗