Potential Biomarkers for Atherosclerosis in Type 2 Diabetic Patients Maintained on Statin Therapy
Type 2 Diabetic Patients Maintained on Statin Therapy
Sponsors
Source
Damanhour University
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Is Us Export
No
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, ninety-five type 2 diabetic patients were eligible and randomly assigned to receive
either 20 mg per day atorvastatin (ATROVA group, n= 40) or 20 mg per day rosuvastatin (ROSUVA
group, n= 35) for three months and twenty patients (Non-statin group, n=20) not treated with
statin and served as control.
Detailed Description
a prospective, open-label trial, conducted between January 2018 and August 2018. Participants
were enrolled if they had moderate cardiovascular risk (Framingham risk score of 10-20%), in
other words 2 or more major risk factors for coronary artery disease (CAD), and
LDL-cholesterol level ≥100 mg/dl. All patients gave informed consent before entering the
study. Of seventy-five patients were randomly assigned to receive either 20 mg per day
atorvastatin (Atrostat®, Delta Pharmaceutical Industries, Cairo, Egypt) tablets (ATROVA
group, n= 40) or 20 mg per day Rosuvastatin (Rosuvastatin Calcium®, Chemipharm Co. Cairo,
Egypt) tablets (ROSUVA group, n= 35) as recommended in NCEP ATP III (21). Twenty patients
(Non-statin group, n=20), not treated with statin, were used for comparison. Patients
included in the study were maintained on oral hypoglycemic agents (OHA) according to their
treatment regimen. Clinical and biochemical assessment was done at baseline and after 12
weeks. Serum High-sensitivity CRP (hsCRP), sortilin, Adiponectin and Leptin level was
determined using ELISA Kit. Blood pressure (BP) and anthropometrical parameters, such as
body-mass index (BMI) were calculated using the equation (BMI = weight (kg)/height (m2).
Blood pressure was measured twice, after keeping participants in a sitting position for 15
min. The mean value of two consecutive measurements with 5 min intervals was used for study
purposes. HbA1c% was determined by ion exchange method. Serum triglycerides (TGs), total
cholesterol (TCH), and high-density lipoprotein cholesterol (HDL-C) were determined
colorimetrically. Low-density lipoprotein-cholesterol (LDL-C) was calculated according to
Friedewald formula. Serum Atherogenic Index (AI) is calculated through the following:
Atherogenic Index = TCH/HDL-C as TCH/HDL-C ratio is an excellent CVD risk predictor and a
good biomarker for deciding on the intensity and the need for therapeutic intervention.
Overall Status
Completed
Start Date
2018-01-01
Completion Date
2018-08-30
Primary Completion Date
2018-08-30
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis. |
3 months |
|
biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis. |
3 months |
|
biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis. |
3 months |
|
biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis. |
3 months |
Secondary Outcome
Measure |
Time Frame |
|
systolic blood pressure. |
3 months |
|
Diastolic blood pressure. |
3 months |
|
glucose level |
3 months |
|
glycated hemoglobin |
3 months |
|
total cholesterol |
3 months |
|
low density lipoprotein-cholesterol |
3 months |
|
high density lipoprotein-cholesterol |
3 months |
|
Triglycerides |
3 months |
Enrollment
77
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
either 20 mg per day atorvastatin (ATROVA group, n= 40) or 20 mg per day rosuvastatin (ROSUVA group, n= 35) for three months and twenty patients (Non-statin group, n=20) not treated with statin and served as control.
Arm Group Label
ATROVA group
Other Name
Rosuvastatin (Rosuvastatin Calcium®, Chemipharm Co. Cairo, Egypt) tablets.
Intervention Type
Drug
Intervention Name
Description
20 mg per day rosuvastatin (ROSUVA group, n= 35) for three months
Arm Group Label
ROSUVA group
Eligibility
Criteria
Inclusion Criteria:
- type II diabetic patients with hypercholesterolemia
Exclusion Criteria:
- 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.
Gender
All
Minimum Age
30 Years
Maximum Age
60 Years
Healthy Volunteers
No
Location
Facility |
|
Tanta University Hospital Tanta 31527 Egypt |
Location Countries
Country
Egypt
Verification Date
2018-12-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Damanhour University
Investigator Full Name
Rehab Werida
Investigator Title
Clinical Pharmacy Lecturer
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
Potential Biomarkers
Number Of Arms
3
Intervention Browse
Mesh Term
Calcium, Dietary
Atorvastatin
Rosuvastatin Calcium
Calcium
Arm Group
Arm Group Label
ATROVA group
Arm Group Type
Experimental
Description
atorvastatin (20 mg per day)
Arm Group Label
ROSUVA group
Arm Group Type
Experimental
Description
Rosuvastatin (20 mg per day)
Arm Group Label
Non-statin group
Arm Group Type
No Intervention
Description
Placebo
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
seventy-five patients were randomly assigned to receive either 20 mg per day atorvastatin (Atrostat®, Delta Pharmaceutical Industries, Cairo, Egypt) tablets (ATROVA group, n= 40) or 20 mg per day Rosuvastatin (Rosuvastatin Calcium®, Chemipharm Co. Cairo, Egypt) tablets (ROSUVA group, n= 35) as recommended in NCEP ATP III (21). Twenty patients (Non-statin group, n=20), not treated with statin, were used for comparison. Patients included in the study were maintained on oral hypoglycemic agents (OHA) according to their treatment regimen.
Primary Purpose
Prevention
Masking
None (Open Label)
Masking Description
prospective, open-label trial
Study First Submitted
December 13, 2018
Study First Submitted Qc
December 21, 2018
Study First Posted
December 24, 2018
Last Update Submitted
December 21, 2018
Last Update Submitted Qc
December 21, 2018
Last Update Posted
December 24, 2018
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.