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NCT Number: NCT03907423

Rosuvastatin on Diabetic Patients Treated With Glimepiride/Metformin

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damanhour Medical National Institute

Damanhūr, N/A = Not Appُlicable, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin10 mg tablet

Drug

Diabetic patients treated with Rosuvastatin 10mg/day plus Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral

Other names: Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral

Placebo oral tablet

Drug

Diabetic patients treated with Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral

Other names: Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral

Primary outcomes

  1. serum levels of fetuin A

    Time frame: three months

    Fetuin-A has a diagnostic potential as a biomarker for liver dysfunction, cardiovascular diseases and disorders associated with metabolic syndrome.

  2. serum levels of Sortilin

    Time frame: three months

    Sortilin is involved in lipid metabolism, promotes the development of atherosclerosis, and possibly becomes a potential therapeutic target for atherosclerosis treatment.

Sponsors and collaborators

Lead sponsor

Rehab Werida

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2019
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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