To Evaluate the Efficacy and Safety of N-acetyl Cysteine Administration in Patients With Diabetic Retinopathy
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Demographic data collection and history taking:
- Age
- Gender
- BMI
- Smoking status
- Diabetes duration
- Family history
- Medical history: Hypertension, Dyslipidemia, etc.
- Medications history especially those related to the occurrence of retinopathy
Clinical assessment, scoring & investigations:
- Systolic and diastolic blood pressures.
- Stage of retinopathy
- Ophthalmologic examination:
- Clinical examination to assess:Visual acuity and Field of vision
Laboratory assessment:
- Blood glucose measurement
- HbA1c level (%)
- HDL cholesterol (mmol/L)
- Non-HDL cholesterol (mmol/L)
- LDL cholesterol (mmol/L)
- Triglyceride (mmol/L)
- Glutathione peroxidase
- 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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studiecontact
- Naam: Nelly tarek Hegazy
- Telefoonnummer: 01010008548
- E-mail: nelly.tariq@pharma.asu.edu.eg
Studie Contact Back-up
- Naam: Lamiaa Elwakeel, Professor
Studie Locaties
-
-
-
Cairo, Egypte
- Werving
- National Institute of Diabetes and Endocrinology.
-
Contact:
- National Institute of Diabetes and Endocrinology. National Institute of Diabetes and Endocrinology.
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: 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.
|
|
|
Experimenteel: NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months.
|
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(
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in glutathione peroxidase levels
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Endocriene systeemziekten
- Vaatziekten
- Hart-en vaatziekten
- Suikerziekte
- Oogziekten
- Diabetische angiopathieën
- Diabetes complicaties
- Ziekten van het netvlies
- Diabetische retinopathie
- Aminozuren, peptiden en eiwitten
- Zwavelverbindingen
- Organische chemicaliën
- Aminozuren
- Cysteïne
- Aminozuren, zwavel
- Acetylcysteïne
Andere studie-ID-nummers
- REC#240
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .