NCT00678522

Brief Summary

We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium excretion, glomerular filtration rate, tubular function and vasoactive hormones in patients with type II diabetes, not in treatment with insulin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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

September 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
Last Updated

May 15, 2008

Status Verified

May 1, 2008

Enrollment Period

8 months

First QC Date

May 13, 2008

Last Update Submit

May 14, 2008

Conditions

Healthy Subjects

Keywords

AtorvastatinRenal functionHemodynamicsDiabetes type IIsodium excretion

Outcome Measures

Primary Outcomes (1)

  • GFR, clearance of sodium and lithium, fractional excretion of sodium and lithium, U-AQP-2, total sodium excretion, albumin excretion rate and free water clearance.

    6 months

Secondary Outcomes (1)

  • AVP, Ang-II, Aldo, ANP, BNP, PRC, BP, HR.

    6 months

Interventions

AtorvastatinDRUG

80 mg atorvastatin daily on two following days

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 40-70 yrs
  • estimated GFR between 30 and 90 ml/min
  • BMI\<35
  • Fertile women had to use oral contraceptives or IUD
  • HbA1c\< 10%
  • Urine-albumin\<1,5 g/l

You may not qualify if:

  • Treatment with insulin
  • Cerobrovascular insult or other disease of the brain
  • Insufficiency of the heart or lungs
  • Liverdisease with ALAT \> 200 U/L
  • hemoglobin \< 7,0 mmol/l
  • Cancer
  • Alcohol abuse
  • Medical treatment with psycopharmaca or/and analgetics
  • Pregnancy and breast feeding, 10 blood donation one month before the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Reseach, Holstebro Hospital

Holstebro, 5500, Denmark

Location

Department of Medical Research, Holstebro Hospital

Holstebro, 7500, 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

  • Erling B. Pedersen, Professor

    Dept. of medical reaserch, Holstebro Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2008

First Posted

May 15, 2008

Study Start

September 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 15, 2008

Record last verified: 2008-05

Locations

DK(2)