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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: Nelly tarek Hegazy
- Telefonnummer: 01010008548
- E-post: nelly.tariq@pharma.asu.edu.eg
Studera Kontakt Backup
- Namn: Lamiaa Elwakeel, Professor
Studieorter
-
-
-
Cairo, Egypten
- Rekrytering
- National Institute of Diabetes and Endocrinology.
-
Kontakt:
- National Institute of Diabetes and Endocrinology. National Institute of Diabetes and Endocrinology.
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: 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.
|
|
|
Experimentell: 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(
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in glutathione peroxidase levels
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Diabetes mellitus
- Ögonsjukdomar
- Diabetiska angiopatier
- Diabeteskomplikationer
- Näthinnesjukdomar
- Diabetisk retinopati
- Aminosyror, peptider och proteiner
- Svavelföreningar
- Organiska kemikalier
- Aminosyror
- Cystein
- Aminosyror, svavel
- Acetylcystein
Andra studie-ID-nummer
- REC#240
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .