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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Nelly tarek Hegazy
- Número de telefone: 01010008548
- E-mail: nelly.tariq@pharma.asu.edu.eg
Estude backup de contato
- Nome: Lamiaa Elwakeel, Professor
Locais de estudo
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Cairo, Egito
- Recrutamento
- National Institute of Diabetes and Endocrinology.
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Contato:
- National Institute of Diabetes and Endocrinology. National Institute of Diabetes and Endocrinology.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: 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.
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Experimental: NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months.
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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(
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes in glutathione peroxidase levels
Prazo: will be measured at time 0 and after 3 months of taking n acetyl cysteine
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Changes in glutathione peroxidase levels in patients with diabetic retinopathy treated with N-acetyl cysteine.
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will be measured at time 0 and after 3 months of taking n acetyl cysteine
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Doenças Vasculares
- Doenças cardiovasculares
- Diabetes Mellitus
- Doenças oculares
- Angiopatias Diabéticas
- Complicações do Diabetes
- Doenças Retinianas
- Retinopatia diabética
- Aminoácidos, peptídeos e proteínas
- Compostos de enxofre
- Produtos químicos orgânicos
- Aminoácidos
- Cisteína
- Aminoácidos, enxofre
- Acetilcisteína
Outros números de identificação do estudo
- REC#240
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