Atorvastatin and Endothelial Function in Type 2 Diabetes Mellitus (ATTEND-Study)

NCT00124397

Last updated date
Study Location
Department of Medical Research
SHF Svendborg, Svendborg, 5700, Denmark
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Type 2 diabetes mellitus,

- Total cholesterol <6.5 mmol/l

- Signed informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Documented CAD or peripheral vascular disease


- Treatment with lipid-lowering drugs


- Contraindications to HMG-CoA reductase therapy


- Potential noncompliance

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Advanced Information
Descriptive Information
Brief Title  ICMJE Atorvastatin and Endothelial Function in Type 2 Diabetes Mellitus (ATTEND-Study)
Official Title  ICMJE Effect of High Dose Statin Therapy on Endothelial Function in Patients With Type 2 Diabetes Mellitus Without CAD
Brief Summary The aim of this study is to examine the effect of intensive cholesterol lowering therapy and tight blood pressure (BP) regulation on endothelial function (inner cell layer of vessels that determines dilatation) in type 2 diabetic patients without documented cardiovascular (CV) disease. The hypothesis is that intensive cholesterol lowering and tight blood pressure regulation will due better than a control group.
Detailed Description

Background:The prevalence of diagnosed type 2 diabetes mellitus (DM) is estimated to 2-4% in the general population in most European countries. DM is associated with an increased frequency of manifest atherosclerotic disease. Data from prospective studies demonstrate that the risk of developing acute coronary syndrome (ACS) in diabetic patients with no prior history of coronary artery disease (CAD) is equivalent to the risk observed in non-diabetics ACS survivors. Most diabetic patients die from CAD. Although DM is primarily a metabolic disorder, it imposes a tremendous burden on macro- and micro-vessel disease.The important question of primary prevention of cardiovascular disease (CVD) in DM remains unanswered.

In the major lipid-intervention studies where patients with CAD were included, the subgroup with DM had at least as good effect of lipid lowering therapy with statins as non-diabetics. The recently published Heart Protection Study supports the hypothesis of a favourable effect of statins in the primary prevention of CVD in DM. The UK Prospective Diabetic Study has proved that tight blood pressure (BP) regulation reduces the frequency of micro- and macrovascular endpoint. It has been suggested that combined lipid lowering with statins and tight BP regulation can have an additive effect in DM patients.

It is well established that the atherosclerotic process has an impact on endothelial function.An improvement of endothelial function by cholesterol lowering and BP reduction may serve as a surrogate endpoint for CAD.

Objective:To assess the effect of intensive lipid lowering on endothelial function in patients with DM and serum cholesterol level <6.5 mmol/l and to evaluate the effect of combined lipid lowering and tight BP regulation on endothelial function in the same patient group.

Methods: This is a single-center, randomised, placebo-controlled study with three treatment arms. Participants are blindly allocated to: 1. atorvastatin 80 mg daily 2. corresponding placebo 3. open label treatment with atorvastatin 80 mg daily and tight BP regulation with 5-10 mg amlodipine, 2-4 mg perindopril, 4-8 mg doxazosin in mono- or combination therapy that aims BP <130/80.

Endothelial function is evaluated at baseline, at 6 and 12 month non-invasively. A high resolution ultrasound scan is performed on the right brachial artery to assess post ischemic flow mediated changes in arterial diameter. Flow mediated dilatation (FMD) depends on an intact endothelium and is mediated via endogenous nitric oxid (NO). To test non-endothelium dependent vasodilatation 0.4 mg of sublingual nitroglycerin (NG) is administrated. NG is a smooth muscle relaxant and acts as a source of NO.There is a well described relation tween endothelial function in the coronary arteries and in the brachial artery.

Sample size: the sample size in the study is based on the following assumptions:

  1. High resolution ultrasound technique has a high accuracy and reproducibility.
  2. The majority of the patients will have endothelial dysfunction
  3. As shown in previous clinical studies, an increase in FMD of 2% is significant at the 95% confidence interval.
  4. Patients randomised to atorvastatin will after one year treatment show an improvement of FMD of at leat 2% compared with the placebo group. Patients treated openly with atorvastatin and BP regulation will have a further improvement of FMD of 2%.

Under these assumptions with a power of 80% and a 2 sided alfa of 5% a sample size of 160 patients are needed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE Drug: Atorvastatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 29, 2005)
186
Original Enrollment  ICMJE
 (submitted: July 26, 2005)
160
Study Completion Date  ICMJE December 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 2 diabetes mellitus,
  • Total cholesterol <6.5 mmol/l
  • Signed informed consent

Exclusion Criteria:

  • Documented CAD or peripheral vascular disease
  • Treatment with lipid-lowering drugs
  • Contraindications to HMG-CoA reductase therapy
  • Potential noncompliance
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00124397
Other Study ID Numbers  ICMJE 20000084
2162
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Southern Denmark
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Kenneth Egstrup, MDDepartment of Medical Research, SHF Svendborg
PRS Account University of Southern Denmark
Verification Date July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP