Rosuvastatin on Diabetic Patients Treated With Glimepiride/Metformin

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effects of Rosuvastatin on Markers of Atherosclerosis in Diabetic Patients Treated With Glimepiride/Metformin Combination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03907423
• Other study ID #: Rosuvastatin on diabetics
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2023
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 31, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Rosuvastatin10 mg tablet
Diabetic patients treated with Rosuvastatin 10mg/day plus Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
• Placebo Oral Tablet
Diabetic patients treated with Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral

Locations

Country	Name	City	State
Egypt	Damanhour Medical National Institute	Damanhur	N/A = Not App?licable

Sponsors (1)

Lead Sponsor	Collaborator
Rehab Werida

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Dabrowska AM, Tarach JS, Wojtysiak-Duma B, Duma D. Fetuin-A (AHSG) and its usefulness in clinical practice. Review of the literature. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2015 Sep;159(3):352-9. doi: 10.5507/bp.2015.018. Epub 2015 Apr 24. — View Citation

Oh TJ, Ahn CH, Kim BR, Kim KM, Moon JH, Lim S, Park KS, Lim C, Jang H, Choi SH. Circulating sortilin level as a potential biomarker for coronary atherosclerosis and diabetes mellitus. Cardiovasc Diabetol. 2017 Jul 20;16(1):92. doi: 10.1186/s12933-017-0568-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum levels of fetuin A	Fetuin-A has a diagnostic potential as a biomarker for liver dysfunction, cardiovascular diseases and disorders associated with metabolic syndrome.	three months
Primary	serum levels of Sortilin	Sortilin is involved in lipid metabolism, promotes the development of atherosclerosis, and possibly becomes a potential therapeutic target for atherosclerosis treatment.	three months