NCT00124397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2001

Longer than P75 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2005

Completed
Last Updated

August 5, 2005

Status Verified

July 1, 2005

First QC Date

July 26, 2005

Last Update Submit

August 4, 2005

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Flow mediated vasodilatation (FMD) on atorvastatin

Secondary Outcomes (4)

  • FMD on combined treatment

  • FMD in relation to lipid levels

  • FMD in relation to BP lowering

  • CV events

Interventions

AtorvastatinDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Documented CAD or peripheral vascular disease
  • Treatment with lipid-lowering drugs
  • Contraindications to HMG-CoA reductase therapy
  • Potential noncompliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research

SHF Svendborg, Svendborg, 5700, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Kenneth Egstrup, MD

    Department of Medical Research, SHF Svendborg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2005

First Posted

July 27, 2005

Study Start

July 1, 2001

Study Completion

December 1, 2004

Last Updated

August 5, 2005

Record last verified: 2005-07

Locations

DK(1)