Rosuvastatin on Diabetic Patients Treated With Glimepiride/Metformin

Rehab Werida

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Rosuvastatin10 mg tablet; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03907423

Rosuvastatin on diabetics

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Rosuvastatin

Experimental group

Description:

DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients)

Treatment:

Drug: Rosuvastatin10 mg tablet

Placebo Group

Placebo Comparator group

Description:

DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).

Treatment:

Drug: Placebo Oral Tablet