Healthy SubjectsPhase 4NCT00678522
The Acute Effect of Atorvastain on Renal Function in Patients With Type II Diabetes
A Phase 4 study testing Atorvastatin in people with Healthy Subjects, run by Regional Hospital Holstebro at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Atorvastatin
- How many people
- 25 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2007to May 2008
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Alcohol abuse
- Medical treatment with psycopharmaca or/and analgetics
- Pregnancy and breast feeding, 10 blood donation one month before the study.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Medical Reseach, Holstebro Hospital
Holstebro, 5500
Department of Medical Research, Holstebro Hospital
Holstebro, 7500
About this study
Official title: The Acute Effect of Atorvastatin on Renal Sodium Excretion, Glomerular Filtration Rate, Tubular Function and Vasoactive Hormones in Patients With Non-Insulin Dependent Type II Diabetes.
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.
- Conditions
- Healthy Subjects
- Being tested
- Atorvastatin
- Keywords
- Atorvastatin, Renal function, Hemodynamics, Diabetes type II, sodium excretion
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
80 mg atorvastatin daily on two following days
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
AVP, Ang-II, Aldo, ANP, BNP, PRC, BP, HR.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startSep 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research
- Investigators
- Erling B. Pedersen, Professor, Principal investigator, Dept. of medical reaserch, Holstebro Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678522
- Sponsor's protocol ID
- MED.RES.HOS.2006.04.LP
- Status last verified
- May 2008
- First submitted
- 13 May 2008
- Last updated
- 15 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Atorvastatin on Renal Sodium Excretion, Glomerular Filtration Rate, Tubular Function and Vasoactive Hormones in Patients With Non-Insulin Dependent Type II Diabetes.
- ClinicalTrials.gov ID
- NCT00678522
- Acronym / sponsor ID
- MED.RES.HOS.2006.04.LP
- Conditions
- Healthy Subjects
- Keywords
- Atorvastatin, Renal function, Hemodynamics, Diabetes type II, sodium excretion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Collaborators
- Medical Research
- Study start
- Sep 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin80 mg atorvastatin daily on two following days | Drug | – |
Primary outcome
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.
Time frame: 6 months
1 secondary outcome
AVP, Ang-II, Aldo, ANP, BNP, PRC, BP, HR.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erling B. Pedersen, Professor principal investigator
Dept. of medical reaserch, Holstebro Hospital, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin in people with Healthy Subjects, run by Regional Hospital Holstebro at 2 sites in Denmark.
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 6 inclusion and 9 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 15 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2008; AzTrials last refreshed its copy on 7 Nov 2026.