Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 Diabetes Mellitus, Black Seed Oil, Endothelial Dysfunction
Brief summary
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 .
Interventions
DIETARY_SUPPLEMENTBlack Seed Oil
Black seed oil soft gelatin capsule
DRUGAnti-Diabetics
standard anti-diabetic treatment prescribed for the patient
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on Markers of Endothelial Dysfunction(The change in the level of soluble intercellular adhesion molecule ( ICAM) in serum using ELISA kit) | three months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on Glycemic Control (Measurement of fasting blood glucose ) | three months | 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) |
| Effect on Glycemic Control (Measurement of glycated hemoglobin) | three months | 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) |
| Effect on Lipid Profile ( Measurement of TC,TG, HDL-C,LDL-C) | three months | it will be assessed at baseline and after three months of treatment |
| Effect on Inflammatory Status ( Measurement of High sensitive C-Reactive Protein using ELISA kit) | three months | it will be assessed at baseline and after three months of treatment |
| Effect on Quality of Life ( Using Diabetes-39 questionnaire ) | three months | it will be assessed at baseline and after three months of treatment |
Countries
Egypt
Outcome results
None listed