Back to results

Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

Primary Purpose

Type 2 Diabetes, Diabetic Dyslipidemia

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Simvastatin

Rosuvastatin

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Statins administration in diabetic dyslipidemia

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Type 2 diabetes in good glycemic control, treated with metformin alone.
Untreated dyslipidemia.
BMI <30.

Exclusion Criteria:

History of cancer.
History of cardiovascular diseases.
Any other acute or cronic illness which requires administration of steroids or other drugs able to interfere with glucose metabolism.

Sites / Locations

University of Rome Tor Vergata

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Simvastatin

Rosuvastatin

Arm Description

Simvastatin 20 mg/day

Rosuvastatin 20 mg/day

Outcomes

Primary Outcome Measures

Glucose tolerance assessed by HbA1c and fasting glucose

Secondary Outcome Measures

insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.

Full Information

NCT ID

NCT00854503

First Posted

March 2, 2009

Last Updated

May 11, 2011

Sponsor

University of Rome Tor Vergata

1. Study Identification

Unique Protocol Identification Number

NCT00854503

Brief Title

Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Rome Tor Vergata

4. Oversight

5. Study Description

Brief Summary

Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading to a significant reduction of cardiovascular risk. More recently, revisions to guidelines have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring the administration of higher dose of statin. However, it is unclear whether high dose statin therapy could affect glycemic control in diabetic patients. Moreover, data regarding the effects of statins on insulin-resistance and endothelial function are controversial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Diabetic Dyslipidemia

Keywords

Statins administration in diabetic dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simvastatin

Arm Type

Active Comparator

Arm Description

Simvastatin 20 mg/day

Arm Title

Rosuvastatin

Arm Type

Active Comparator

Arm Description

Rosuvastatin 20 mg/day

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Intervention Description

20 mg/day in one oral administration

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Intervention Description

20 mg/day in one oral administration.

Primary Outcome Measure Information:

Title

Glucose tolerance assessed by HbA1c and fasting glucose

Time Frame

1, 6, 12 months

Secondary Outcome Measure Information:

Title

insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.

Time Frame

1, 6, 12 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 2 diabetes in good glycemic control, treated with metformin alone. Untreated dyslipidemia. BMI <30. Exclusion Criteria: History of cancer. History of cardiovascular diseases. Any other acute or cronic illness which requires administration of steroids or other drugs able to interfere with glucose metabolism.

Facility Information:

Facility Name

University of Rome Tor Vergata

City

Rome

ZIP/Postal Code

00133

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

We'll reach out to this number within 24 hrs