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Dyslipidemia Associated With Type II Diabetes MellitusPhase 4NCT03784703

Type 2 Diabetic Patients Maintained on Statin Therapy

A Phase 4 study testing Atorvastatin 40 Mg Oral Tablet and Rosuvastatin 10 Mg Oral Tablet in people with Dyslipidemia Associated With Type II Diabetes Mellitus, run by Damanhour University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 70 years
What is being tested?
Atorvastatin 40 Mg Oral Tablet and Rosuvastatin 10 Mg Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteEgypt
Study dates
1 Jan 2018to 31 Jan 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • type II diabetic patients with hypercholesterolemia

Who cannot join

  • liver impairment,
  • renal insufficiency,
  • coronary artery disease,
  • metabolic disorders,
  • type I diabetes,
  • autoimmune diseases, cancer, infection,
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Tanta University Hospital

    Tanta, El-Gharbia, 31527

Other trials in Egypt

About this study

Official title: Efficacy of Atorvastatin Versus Rosuvastatin on LV Function and Inflammatory Biomarkers in Type 2 Diabetic Patients With Dyslipidemia

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.

Read the detailed description

a prospective, double blind trial, conducted between January 2018 and January 2020. 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 150 patients were randomly assigned to receive either 40 mg per day atorvastatin tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin (Rosuvastatin Calcium®, Chemipharm Co. Cairo, Egypt) 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. Clinical and biochemical assessment was done at baseline and after 6 months. 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. 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.

Being tested
Atorvastatin 40 Mg Oral Tablet, Rosuvastatin 10 Mg Oral Tablet
Keywords
Adiponectin, Sortilin, Leptin, Dyslipidemia, Diabetes type II, Rosuvastatin, Atorvastatin
Medical subject headings
Dyslipidemias, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atorvastatin 40 Mg Oral TabletDrug

    Also called Atorvastatin 40mg tablet per day

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

  • Rosuvastatin 10 Mg Oral TabletDrug

    Also called Resovastatin 10 mg daily

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

Study groups in NCT03784703
Study groupRoleWhat they receive
AtrovastatinExperimentalatorvastatin (40 mg per day) for 6 months
Receives: Drug: Atorvastatin 40 Mg Oral Tablet
RosuvastatinExperimentalRosuvastatin (10 mg per day) for 6 months
Receives: Drug: Rosuvastatin 10 Mg Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hs-CRP (pg/mL)

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

    Measured: 6 months

  2. sortilin (ng/mL)

    Serum Level

    Measured: 6 months

  3. adiponectin (ng/mL)

    Serum Level

    Measured: 6 months

  4. leptin (ng/mL)

    Serum Level

    Measured: 6 months

Secondary outcomes (6)

  1. glucose level

    fasting blood glucose (FBG) (mg/mL)

    Measured: 6 months

  2. glycated hemoglobin

    glycated hemoglobin (Hb A1c%)

    Measured: 6 months

  3. total cholesterol

    TCH: total cholesterol (mg/dL)

    Measured: 6 months

  4. low density lipoprotein-cholesterol

    LDL-C: low density lipoprotein-cholesterol (mg/dL), HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).

    Measured: 6 months

  5. high density lipoprotein-cholesterol

    HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).

    Measured: 6 months

  6. Triglycerides

    Triglycerides (mg/dL).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2018
  2. Study start1 Jan 2018
  3. Primary completion30 Jan 2020
  4. Study completion31 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03784703
Sponsor's protocol ID
Statin Therapy
Status last verified
Dec 2020
First submitted
13 Dec 2018
Last updated
5 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24354929

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atorvastatin 40 Mg Oral Tablet and Rosuvastatin 10 Mg Oral Tablet in people with Dyslipidemia Associated With Type II Diabetes Mellitus, run by Damanhour University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hs-CRP (pg/mL) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03784703, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.

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