HypertensionPhase 4NCT00335413
Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy
A Phase 4 study testing Spironolactone in people with Hypertension, run by Steno Diabetes Center Copenhagen.
Trial summary
To evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive type 1 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Spironolactone
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Apr 2007
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes
- Age between 18 and 70 years
- Blood pressure ≥ 135 mm Hg systolic and/or ≥ 85 mm Hg diastolic or ongoing antihypertensive treatment
- Informed consent
Who cannot join
- Diabetic nephropathy
- Other known kidney or renal tract disease
- Malignant hypertension
- Blood pressure > 170/105 at baseline or during AHT wash-out period
- Plasma potassium > 4.7 mmol/l
- Elevated plasma creatinine (>88 µmol/l for women and >100 µmol/l for men)
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- Symptoms of Ischemic heart disease within 3 months prior to study start
- Previous cerebrovascular event (apoplexy, TCI)
- Abuse of medicine or alcohol
- Pregnancy or breastfeeding
- Woman of child-bearing age who are not using adequate contraception
- ASA treatment > 1g/day or regular use of NSAIDs
- Known allergy to or side-effects of spironolactone
- Inability to understand patient information
About this study
To evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive type 1 diabetic patients.
Read the detailed description
Double-masked, randomized, crossover trial. In random order, patients will be treated with spironolactone 25 mg o.d. and matched placebo for 28 days.
On the last day of treatment, GFR will be determined twice on the same day: first without clonidine and secondly after injection of clonidine (clonidine induces a transient reduction in blood pressure, with no influence on renal plasma flow and GFR), in order to evaluate the effect of antihypertensive treatment with spironolactone on renal autoregulation of GFR.
The study will be preceded by a wash-out period of 1 month for patients receiving antihypertensive medication. Patients will be instructed to measure blood pressure twice daily, three days a week during this period. If, during the washout period, blood pressure exceeds 170/105 mm Hg or persistent edemas develop, treatment with long-acting loop diuretics will be initiated and continued throughout the rest of the study. If blood pressure despite diuretic treatment still exceeds 170 mm Hg systolic and/or 105 mm Hg diastolic, the patient will be excluded from the study and previous/appropriate antihypertensive treatment will be restarted.
- Conditions
- Hypertension
- Being tested
- Spironolactone
- Keywords
- Renal autoregulation, Glomerular filtration rate, Type 1 diabetes
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glomerular filtration rate
Secondary outcomes (3)
Changes in blood pressure
Changes in albuminuria
Changes in fractional albumin clearance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startJun 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Hans-Henrik Parving, MD,DMSc,Prof, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335413
- Sponsor's protocol ID
- 2006-001453-10
- Other IDs
- 2612-3144, KA-20060055
- Status last verified
- Jun 2008
- First submitted
- 7 Jun 2006
- Last updated
- 5 Jun 2008
- Results posted
- No
Publications
Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
PubMed 33107592
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy
- ClinicalTrials.gov ID
- NCT00335413
- Acronym / sponsor ID
- 2006-001453-10
- Conditions
- Hypertension
- Keywords
- Renal autoregulation, Glomerular filtration rate, Type 1 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 9 Jun 2006 (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.
To evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive type 1 diabetic patients.
Detailed description
Double-masked, randomized, crossover trial. In random order, patients will be treated with spironolactone 25 mg o.d. and matched placebo for 28 days.
On the last day of treatment, GFR will be determined twice on the same day: first without clonidine and secondly after injection of clonidine (clonidine induces a transient reduction in blood pressure, with no influence on renal plasma flow and GFR), in order to evaluate the effect of antihypertensive treatment with spironolactone on renal autoregulation of GFR.
The study will be preceded by a wash-out period of 1 month for patients receiving antihypertensive medication. Patients will be instructed to measure blood pressure twice daily, three days a week during this period. If, during the washout period, blood pressure exceeds 170/105 mm Hg or persistent edemas develop, treatment with long-acting loop diuretics will be initiated and continued throughout the rest of the study. If blood pressure despite diuretic treatment still exceeds 170 mm Hg systolic and/or 105 mm Hg diastolic, the patient will be excluded from the study and previous/appropriate antihypertensive treatment will be restarted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 diabetes
- Age between 18 and 70 years
- Blood pressure ≥ 135 mm Hg systolic and/or ≥ 85 mm Hg diastolic or ongoing antihypertensive treatment
- Informed consent
Key exclusion criteria (14 listed)
- Diabetic nephropathy
- Other known kidney or renal tract disease
- Malignant hypertension
- Blood pressure > 170/105 at baseline or during AHT wash-out period
- Plasma potassium > 4.7 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 |
|---|---|---|
| Spironolactone | Drug | – |
Primary outcome
Changes in glomerular filtration rate
3 secondary outcomes
Changes in blood pressure
Changes in albuminuria
Changes in fractional albumin clearance
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 5 Jun 2008.
- Derived from this study: PubMed 33107592Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
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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.
Hans-Henrik Parving, MD,DMSc,Prof principal investigator
Steno Diabetes Center Copenhagen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spironolactone in people with Hypertension, run by Steno Diabetes Center Copenhagen.
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 4 inclusion and 14 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 5 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in glomerular filtration rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00335413, which also lists 1 linked publication.
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 5 Jun 2008.