Studies
| Study First Submitted Date | 2020-08-21 |
| Study First Posted Date | 2020-08-28 |
| Last Update Posted Date | 2020-08-28 |
| Start Month Year | October 1, 2019 |
| Primary Completion Month Year | November 1, 2020 |
| Verification Month Year | August 2020 |
| Verification Date | 2020-08-31 |
| Last Update Posted Date | 2020-08-28 |
Detailed Descriptions
| Sequence: | 20643203 |
| Description | This study will be carried on 60 participants with Type 2 Diabetes with age over 20 years. Participants will be classified into two groups: Group I (Interventional): treated with (NAC) dose of 1200 mg/day for two months in conjunction with conventional treatment. Group II (Non-interventional): control group receive conventional treatment. All patients will undergo the following: Full medical history will be taken. Laboratory investigations as follows: Blood samples will be collected for analysis after overnight fasting at the beginning and after 2 months of the study for determination of: Total cholesterol (T-chol). Plasma triglycerides (TG). High density lipoprotein cholesterol (HDL-C). Low density lipoprotein cholesterol (LDL-C). Fasting blood sugar. Blood urea nitrogen (BUN). Serum creatinine (SCr). Urine analysis. Glycated hemoglobin (HbA1c). Lipoprotein (a). In addition, blood pressure will be measured for 24 hr. |
Facilities
| Sequence: | 199229337 |
| Name | Al Azhar University |
| City | Cairo |
| Zip | 11651 |
| Country | Egypt |
Browse Interventions
| Sequence: | 95660798 | Sequence: | 95660799 | Sequence: | 95660800 | Sequence: | 95660801 | Sequence: | 95660802 | Sequence: | 95660803 | Sequence: | 95660804 | Sequence: | 95660805 | Sequence: | 95660806 | Sequence: | 95660807 | Sequence: | 95660808 | Sequence: | 95660809 |
| Mesh Term | Acetylcysteine | Mesh Term | N-monoacetylcystine | Mesh Term | Antiviral Agents | Mesh Term | Anti-Infective Agents | Mesh Term | Expectorants | Mesh Term | Respiratory System Agents | Mesh Term | Free Radical Scavengers | Mesh Term | Antioxidants | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Protective Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Antidotes |
| Downcase Mesh Term | acetylcysteine | Downcase Mesh Term | n-monoacetylcystine | Downcase Mesh Term | antiviral agents | Downcase Mesh Term | anti-infective agents | Downcase Mesh Term | expectorants | Downcase Mesh Term | respiratory system agents | Downcase Mesh Term | free radical scavengers | Downcase Mesh Term | antioxidants | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | protective agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | antidotes |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 51967602 | Sequence: | 51967603 | Sequence: | 51967604 |
| Name | Diabetic Kidney Disease | Name | Diabetes Mellitus, Type 2 | Name | Diabetic Nephropathies |
| Downcase Name | diabetic kidney disease | Downcase Name | diabetes mellitus, type 2 | Downcase Name | diabetic nephropathies |
Id Information
| Sequence: | 40000246 |
| Id Source | org_study_id |
| Id Value | AlAzharUn |
Countries
| Sequence: | 42391182 |
| Name | Egypt |
| Removed | False |
Design Groups
| Sequence: | 55368893 | Sequence: | 55368894 |
| Group Type | Experimental | Group Type | No Intervention |
| Title | Interventional | Title | Non-interventional |
| Description | 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. | Description | Second arm has no intervention. It is only used to compare results of analytical tests with the first interventional arm. |
Interventions
| Sequence: | 52279355 |
| Intervention Type | Drug |
| Name | N Acetylcysteine |
| Description | (NAC) is a drug used in the experiment and participant are treated with it by 1200mg/day dose for two months. |
Keywords
| Sequence: | 79549272 | Sequence: | 79549273 | Sequence: | 79549274 | Sequence: | 79549275 | Sequence: | 79549276 | Sequence: | 79549277 | Sequence: | 79549278 | Sequence: | 79549279 | Sequence: | 79549280 | Sequence: | 79549281 | Sequence: | 79549282 |
| Name | N-Acetyl cysteine | Name | Lipoprotein a | Name | Triglycerides | Name | Total cholesterol | Name | Glycated Haemoglobin | Name | Fasting blood sugar | Name | Serum creatinine | Name | Blood urea nitrogen | Name | Urine analysis | Name | High density lipoprotein | Name | Low density lipoprotein |
| Downcase Name | n-acetyl cysteine | Downcase Name | lipoprotein a | Downcase Name | triglycerides | Downcase Name | total cholesterol | Downcase Name | glycated haemoglobin | Downcase Name | fasting blood sugar | Downcase Name | serum creatinine | Downcase Name | blood urea nitrogen | Downcase Name | urine analysis | Downcase Name | high density lipoprotein | Downcase Name | low density lipoprotein |
Design Outcomes
| Sequence: | 176655245 | Sequence: | 176655246 | Sequence: | 176655247 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
| Measure | Lipoprotein (a) | Measure | Triglycerides | Measure | Systolic blood pressure |
| Time Frame | 2 months | Time Frame | 2 months | Time Frame | 2 months |
| Description | unique lipoprotein that has emerged as an independent risk factor for developing vascular disease. | Description | 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. | Description | 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. |
Browse Conditions
| Sequence: | 192680415 | Sequence: | 192680416 | Sequence: | 192680417 | Sequence: | 192680418 | Sequence: | 192680419 | Sequence: | 192680420 | Sequence: | 192680421 | Sequence: | 192680422 | Sequence: | 192680423 | Sequence: | 192680424 | Sequence: | 192680425 | Sequence: | 192680426 | Sequence: | 192680427 |
| Mesh Term | Kidney Diseases | Mesh Term | Diabetic Nephropathies | Mesh Term | Diabetes Mellitus | Mesh Term | Diabetes Mellitus, Type 2 | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Metabolic Diseases | Mesh Term | Endocrine System Diseases | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases | Mesh Term | Diabetes Complications |
| Downcase Mesh Term | kidney diseases | Downcase Mesh Term | diabetic nephropathies | Downcase Mesh Term | diabetes mellitus | Downcase Mesh Term | diabetes mellitus, type 2 | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | endocrine system diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | diabetes complications |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48128590 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Al-Azhar University |
Overall Officials
| Sequence: | 29168887 |
| Role | Study Chair |
| Name | Huda M. Salem, PhD |
| Affiliation | ALAZHAR UNIVERSITY |
Design Group Interventions
| Sequence: | 67875523 |
| Design Group Id | 55368893 |
| Intervention Id | 52279355 |
Eligibilities
| Sequence: | 30645702 |
| Gender | All |
| Minimum Age | 20 Years |
| Maximum Age | N/A |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Criteria | Inclusion Criteria: Confirmed diagnosis of Diabetes Mellitus. Age over 20 years. Patients with proteinuria ≥ 30 mg /dl. Exclusion Criteria: Patients on lipid lowering medications. Cigarette smokers. Presence of liver and heart diseases. |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254226846 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 20 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 3 |
Designs
| Sequence: | 30392600 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | None (Open Label) |
| Masking Description | All participants,investigators, care providers, and outcome assessor have knowledge of the interventions assigned to individual participants. |
| Intervention Model Description | 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. |
Intervention Other Names
| Sequence: | 26564898 | Sequence: | 26564899 |
| Intervention Id | 52279355 | Intervention Id | 52279355 |
| Name | (NAC) | Name | Fluimucil |
Responsible Parties
| Sequence: | 28759068 |
| Responsible Party Type | Principal Investigator |
| Name | Tasneem Ahmed Hamed |
| Title | Clinical pharamacist |
| Affiliation | Al-Azhar University |