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The study is focused on the possible improving effect of N-acetylcysteine on nephropathy of type-2 diabetic patients.
Study design: Prospective clinical based study. The aim of this work is to study the effect of N-acetylcysteine (NAC) on proteinuria and on the serum level of lipoprotein a (LPa) in diabetes induced nephropathy in type-2 diabetic patients.
This study will be carried on 60 participants with Type 2 Diabetes with age over 20 years.
Participants will be classified into two groups:
All patients will undergo the following:
Blood samples will be collected for analysis after overnight fasting at the beginning and after 2 months of the study for determination of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | First arm is experimental, given (NAC) for 2 months in 1200mg/day dosing. Both arms are assigned to pre-treatment analytical tests and post treatment all test analysis are repeated to compare drug effect with placebo group. |
|
| Non-interventional | No Intervention | Second arm has no intervention. It is only used to compare results of analytical tests with the first interventional arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N Acetylcysteine | Drug | (NAC) is a drug used in the experiment and participant are treated with it by 1200mg/day dose for two months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lipoprotein (a) | unique lipoprotein that has emerged as an independent risk factor for developing vascular disease. | 2 months |
| Triglycerides | Triglycerides are a type of fat (lipid) found in our blood. It is one of the lipid panel used to determine atherosclerotic risk that contributes to vascular diseases. | 2 months |
| Systolic blood pressure | The first number of blood pressure reading and it indicates how much pressure our blood is exerting against our artery walls when the heart beats. It is a major risk factor for cardiovascular disease. | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huda M. Salem, PhD | Al-Azhar University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Azhar University | Cairo | 11651 | Egypt |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Two arms are being used parallel to each other at the same time. Participants are assigned to two groups in parallel for the duration of the study. One arm is interventional assigned to drug administration and the other is a control arm.
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All participants,investigators, care providers, and outcome assessor have knowledge of the interventions assigned to individual participants.
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |