Diabetes Mellitus, Type 2
Conditions
Keywords
T2DM.
Brief summary
study effects of rosuvastatin on markers of atherosclerosis, thrombosis, in diabetic patients treated with glimepiride/metformin without coronary artery disease. This effect will be investigated especially on sortilin ,fetuin-A
Detailed description
A randomized controlled trial on 70 patients with DM type 2 will be recruited from Damanhour national medical institute. * Subjects will be divided into two group (one arm is DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients) and another arm is DM-type 2 patient who will receive glimepiride-metformin combination (30 patients). * Determination of serum levels of fetuin A and Sortilin * Blood samples will be collected after 3-month after active treatment. * Outcomes measurement : Sortilin ,fetuinA, Atherogenic index (AI) and coronary risk index (CRI) . Methodology * Sortilin, fetuinA will be determined by ELISA. * Lipid profile. * FBG and Hb A1C will be measured. * Atherogenic index (AI = LDL-C/HDL-C) and CRI (CRI = TC/HDL-C) will be calculated for all subjects.
Interventions
Diabetic patients treated with Rosuvastatin 10mg/day plus Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
DRUGPlacebo Oral Tablet
Diabetic patients treated with Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
Sponsors
Rehab Werida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Subjects will be divided into two group (one arm is DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients) and another arm is DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus on oral therapy. * Age 21-65 years * Life expectancy \>1 year.
Exclusion criteria
* Documented CVD * Planned surgical intervention. * Hypersensitivity to either of the study drug components. * Type I diabetes. * Current Insulin treatment. * Hepatic impairment known hepatic failure. * Inability to comply with study protocol. * Active malignancy. * Chronic inflammation (i.e. inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection). * Pregnancy, lactation or child-bearing potential. * Chronic renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum levels of fetuin A | three months | Fetuin-A has a diagnostic potential as a biomarker for liver dysfunction, cardiovascular diseases and disorders associated with metabolic syndrome. |
| serum levels of Sortilin | three months | Sortilin is involved in lipid metabolism, promotes the development of atherosclerosis, and possibly becomes a potential therapeutic target for atherosclerosis treatment. |
Countries
Egypt
Outcome results
None listed