Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effect of Black Seed Oil on Markers of Endothelial Dysfunction in Patients With Type 2 Diabetes Mellitus
| Verified date | May 2019 |
| Source | Ain Shams University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine the effect of black seed oil on markers of endothelial dysfunction in patients with type 2 diabetes mellitus .Also, to investigate its effect on glycemic control ,lipid profile and quality of life of those patients .
| Status | Active, not recruiting |
| Enrollment | 50 |
| Est. completion date | August 2019 |
| Est. primary completion date | August 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Age: adult patients with more than or equal 18 years old. 2. Previous diagnosis of Diabetes mellitus type 2 according to American Diabetes Association Criteria (ADA). 3. Approval to participate and give informed consent. Exclusion Criteria: 1. Unstable coronary artery disease, cardiac arrhythmia or congestive heart failure. 2. Uncontrolled hypertension or recent stroke. 3. Chronic kidney disease or chronic liver disease. 4. Intake of black seed oil during the previous two months or any other antioxidant. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Ain Shams University Hospitals | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Ain Shams University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effect on Markers of Endothelial Dysfunction(The change in the level of soluble intercellular adhesion molecule ( ICAM) in serum using ELISA kit) | it will be assessed at baseline and after three months of treatment ( to determine the change from baseline at three months ) to determine whether it is effective in reducing marker of endothelial dysfunction (ICAM) in patients with type 2 diabetes mellitus | three months | |
| Secondary | Effect on Glycemic Control (Measurement of fasting blood glucose ) | it will be assessed at baseline and after three months of treatment to determine the anti-diabetic effect of black seed oil ( if it is effective in reducing fasting blood glucose from baseline) | three months | |
| Secondary | Effect on Glycemic Control (Measurement of glycated hemoglobin) | it will be assessed at baseline and after three months of treatment to determine the anti-diabetic effect of black seed oil ( if it is effective in reducing glycated hemoglobin from baseline) | three months | |
| Secondary | Effect on Lipid Profile ( Measurement of TC,TG, HDL-C,LDL-C) | it will be assessed at baseline and after three months of treatment | three months | |
| Secondary | Effect on Inflammatory Status ( Measurement of High sensitive C-Reactive Protein using ELISA kit) | it will be assessed at baseline and after three months of treatment | three months | |
| Secondary | Effect on Quality of Life ( Using Diabetes-39 questionnaire ) | it will be assessed at baseline and after three months of treatment | three months |
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|---|---|---|---|
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