Type 2 Diabetic Patients Maintained on Statin Therapy

NCT03784703 | Completed Phase 4

• 1 other identifier: Statin Therapy
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with diabetes mellitus (DM) are at increased risk of atherosclerotic cardiovascular disease (ACVD). The achievement of the LDL-C target with statins for the reduction of ACVD risk is recommended. However, the risk is still present. Therefore, we investigated the impact of high sensitivity C-reactive protein (hsCRP), sortilin, adiponectin and leptin biomarkers that linking inflammatory hypothesis of diabetes mellitus and atherosclerosis in diabetic patients treated with rosuvastatin and atrovastatin. Methods: Based on exclusion criteria, 150 type 2 diabetic patients were eligible and randomly assigned to receive either 40 mg per day atorvastatin (ATROVA group, n= 80) or 10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months.

Conditions

Dyslipidemia Associated With Type II Diabetes Mellitus

Keywords

Adiponectin; Sortilin; Leptin; Dyslipidemia; Diabetes type II; Rosuvastatin; Atorvastatin

Outcome Measures

Primary Outcomes (4)

• hs-CRP (pg/mL)

  biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis.

  6 months

• sortilin (ng/mL)

  Serum Level

  6 months

• adiponectin (ng/mL)

  Serum Level

  6 months

• leptin (ng/mL)

  Serum Level

  6 months

Secondary Outcomes (6)

• glucose level

  6 months

• glycated hemoglobin

  6 months

• total cholesterol

  6 months

• low density lipoprotein-cholesterol

  6 months

• high density lipoprotein-cholesterol

  6 months

Study Arms (2)

Atrovastatin

EXPERIMENTAL

atorvastatin (40 mg per day) for 6 months

Drug: Atorvastatin 40 Mg Oral Tablet

Rosuvastatin

EXPERIMENTAL

Rosuvastatin (10 mg per day) for 6 months

Drug: Rosuvastatin 10 Mg Oral Tablet

Interventions

Atorvastatin 40 Mg Oral Tablet DRUG

40 mg per day atorvastatin (ATROVA group, n= 80) for 6 months

Also known as: Atorvastatin 40mg tablet per day

Atrovastatin

Rosuvastatin 10 Mg Oral Tablet DRUG

10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months

Also known as: Resovastatin 10 mg daily

Rosuvastatin

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type II diabetic patients with hypercholesterolemia

You may not qualify if:

• liver impairment,
• renal insufficiency,
• coronary artery disease,
• metabolic disorders,
• type I diabetes,
• autoimmune diseases, cancer, infection,
• use of anti-inflammatory drugs,
• recent major surgery,
• weight-loss or modified anti-hypertensive medications 12 weeks or less prior to enrolment,
• ongoing or previous use of lipid-lowering medications (including other statins, fibric acid derivatives, nicotinic acid, cholestyramine, ezetimibe or omega-3 fatty acids) and contraindications to the use of statins.

Sponsors & Collaborators

• Damanhour University: lead
• Tanta University: collaborator

Study Sites (1)

Tanta University Hospital

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (1)

• Krysiak R, Zmuda W, Okopien B. The effect of simvastatin-ezetimibe combination therapy on adipose tissue hormones and systemic inflammation in patients with isolated hypercholesterolemia. Cardiovasc Ther. 2014 Apr;32(2):40-6. doi: 10.1111/1755-5922.12057.

  PMID: 24354929 BACKGROUND

MeSH Terms

Conditions

Dyslipidemias; Diabetes Mellitus, Type 2

Interventions

Atorvastatin; Tablets; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Rehab Werida, Lecturer

  Damanhour University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: prospective, double blind trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Lecturer

Model Details: 160 patients were randomly assigned to receive either 40 mg per day atorvastatin tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin tablets (ROSUVA group, n= 80) as recommended in NCEP ATP III (21). Patients included in the study were maintained on oral hypoglycemic agents (OHA) according to their treatment regimen.

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 24, 2018
• Study Start: January 1, 2018
• Primary Completion: January 30, 2020
• Study Completion: January 31, 2020
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)