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To Evaluate the Efficacy and Safety of N-acetyl Cysteine Administration in Patients With Diabetic Retinopathy

3. juni 2026 opdateret af: Nelly Hegazy, Ain Shams University

Effect of N-Acetyl Cysteine on Oxidative Stress and Clinical Outcome of Patients With Diabetic Retinopathy

N-acetylcysteine (NAC) emerges as a crucial factor in mitigating oxidative stress and inhibiting vascular endothelial activation in diabetic patients, through its effect on VEGF expression as VEGF is involved in the development of diabetic microvascular complications through the promotion of retinal angiogenesis and increased vascular permeability.

It was reported in the literature that NAC administration was safe in several studies. It was shown that the dose of 1200 mg is safe and effective.

To the best of our knowledge, the present study is the first to be designed to evaluate the effect of N-acetyl cysteine on diabetic retinopathy in type 2 diabetic patients.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Eligible patients will be randomly assigned into one of two groups. In the first group : patients will receive N-acetyl cysteine 1200 mg once daily for three months.

In addition to the standard of care antidiabetic management. In the second group: patients will take matched placebo for three months. In addition to the standard of care antidiabetic management.

  1. Demographic data collection and history taking:

    1. Age
    2. Gender
    3. BMI
    4. Smoking status
    5. Diabetes duration
    6. Family history
    7. Medical history: Hypertension, Dyslipidemia, etc.
    8. Medications history especially those related to the occurrence of retinopathy

  2. Clinical assessment, scoring & investigations:

    1. Systolic and diastolic blood pressures.
    2. Stage of retinopathy
    3. Ophthalmologic examination:
    4. Clinical examination to assess:Visual acuity and Field of vision

  3. Laboratory assessment:

    1. Blood glucose measurement
    2. HbA1c level (%)
    3. HDL cholesterol (mmol/L)
    4. Non-HDL cholesterol (mmol/L)
    5. LDL cholesterol (mmol/L)
    6. Triglyceride (mmol/L)
    7. Glutathione peroxidase
    8. VEGF All patients will be followed up regularly for 3 months during the study period. They will be followed up weekly through telephone calls and will return every 4 weeks for clinical evaluation as well as verification of adherence to the study regimen. Any addition or deletion of a medication used by the study patients will be reported and dealt with if necessary.

At the end of the study the same tests will be repeated to compare the patients before and after taking N-acetyl cysteine.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

76

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Lamiaa Elwakeel, Professor

Studiesteder

  • Egypten
      • Cairo, Egypten
        • Rekruttering
        • National Institute of Diabetes and Endocrinology.
        • Kontakt:
          • National Institute of Diabetes and Endocrinology. National Institute of Diabetes and Endocrinology.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus

    • Patients with mild to moderate degrees of diabetic retinopathy
    • Patients over the age of 18 and under the age of 70 years
    • Patients who voluntarily give their informed consent
    • HbA1C (glycosylated hemoglobin) less than 10%
    • FBG less than 240 mg/dl
    • Body mass index (BMI) less than 40 kg/m2

Exclusion Criteria:

  • • Patients with any other ophthalmologic conditions than diabetic retinopathy

    • Patients with previous surgical or laser treatment
    • Pregnant or breastfeeding patients
    • Patients using antioxidants.
    • Systemic anti-VEGF or pro-VEGF treatment within 4 months before randomization
    • Patients who are currently participating in other clinical trials
    • Severe liver or renal disease, (AST or ALT >3 times ULN or Total bilirubin >3 times ULN), (CrCl< 60 ml/min)
    • Current history of drug or alcohol abuse Malignancies

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: NPDR patients will receive placebo for three months.
The patients will receive placebo for three months. In addition to the standard of care antidiabetic management.
Eksperimentel: NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months.
Medicin: N Acetyl cysteine, 1200mg (high dose)
N-acetylcysteine (NAC), alternatively referred to as N-acetyl-L-cysteine, is an acetylated version of the amino acid L-cysteine, with the chemical formula C5H9NO3S. Initially employed to thin stubborn bronchial secretions, NAC has found application in treating chronic bronchitis and various pulmonary ailments to address thick mucus. Remarkably, NAC functions as both a direct antioxidant and a precursor to glutathione. It effectively eliminates reactive oxygen species (ROS), such as hydroxyl radicals, hypochlorous acid, and hydrogen peroxide. These ROS have the potential to oxidize lipids, proteins, and DNA, generating carbon-centered radicals along the DNA backbone, ultimately leading to cell death.The thiol group in NAC is responsible for its antioxidant properties. Additionally, NAC can be metabolized into cysteine, a key building block in the synthesis of glutathione. Glutathione plays a crucial role as an antioxidant, protecting cellular components from damage caused by ROS(

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in glutathione peroxidase levels
Tidsramme: will be measured at time 0 and after 3 months of taking n acetyl cysteine
Changes in glutathione peroxidase levels in patients with diabetic retinopathy treated with N-acetyl cysteine.
will be measured at time 0 and after 3 months of taking n acetyl cysteine

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ain Shams University

Samarbejdspartnere

National Institute of Diabetes and Endocrinology, Egypt

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. januar 2026

Primær færdiggørelse (Anslået)

30. december 2026

Studieafslutning (Anslået)

30. december 2026

Datoer for studieregistrering

Først indsendt

24. maj 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • REC#240

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetisk retinopati (DR)

Kliniske forsøg med N Acetyl cysteine, 1200mg (high dose)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gabon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner