Type 2 DiabetesNCT01101269
Effect of Angiotensin Converting Enzyme Inhibitor, Lisinopril, on Renal Blood Flow and Its Correlation With Proteinuria Reduction in Subjects With Type 2 Diabetes and Kidney Disease
A study testing ACEI or ARB and Lisinopril in people with Type 2 Diabetes, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of the study is to investigate the effect of a blood pressure medication, Lisinopril, or similar drugs in that class, on the flow of blood to the kidneys. In this study, we will compare blood flow to the kidneys in healthy people that do not have diabetes or kidney disease with people that have diabetes… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- ACEI or ARB and Lisinopril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2014
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (ages 40 - 75 years)
- Diagnosis of type 2 diabetes for more than 5 years
- Evidence of diabetic nephropathy as evidenced by
- More than 150 mg of proteinuria per day in a 24-hour urine collection, or a spot morning urine protein to creatinine of greater than 0.15, or a spot morning urine albumin to creatinine ratio greater than 100 confirmed on two separate occasions within 12 months
- Treatment with a blocker of the renin -angiotensin-aldosterone system (either ACE inhibitor or ARB)
- For healthy controls,
- Adults (ages 40 - 75 years)
- Good general health
Who cannot join
- Type 1 diabetes
- Glomerular filtration rate less than 40 ml/min/1.73 m2 by MDRD formula
- Hemoglobin A1C greater than 10%
- Blood pressure greater than 150/90 mm Hg or less than 100/55 mm Hg
- History of kidney transplantation
- Oxygen saturation is less than 80%
Show all 16Show fewer
- History of unstable cardiopulmonary conditions, known intracardiac shunts, or pulmonary hypertension
- History of active cancer within the last 3 years
- For healthy controls,
- History or clinical evidence of any chronic disease
- Chronic and regular use of any medications except for oral contraceptives and vitamins
- Clinically significant abnormal screening laboratory values
- Pregnancy or lactation for women
- Blood pressure at screening visit less than 110/60
- History of unstable cardiopulmonary conditions, known intracardiac shunts, or pulmonary hypertension
- History of active cancer within the last 3 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: Effect of Angiotensin Converting Enzyme Inhibitor, Lisinopril, on Renal Blood Flow and Its Correlation With Proteinuria Reduction in Subjects With Type 2 Diabetes and Kidney Disease (KXK005).
The purpose of the study is to investigate the effect of a blood pressure medication, Lisinopril, or similar drugs in that class, on the flow of blood to the kidneys. In this study, we will compare blood flow to the kidneys in healthy people that do not have diabetes or kidney disease with people that have diabetes and evidence of kidney disease.
Read the detailed description
Blockers of renin angiotensin aldosterone system (RAAS) are considered the standard of care in treatment of diabetic nephropathy. Their effects are thought to be through multiple mechanisms, including reducing intraglomerular pressure. However, due to the lack of a sensitive, practical and noninvasive method of monitoring renal hemodynamics, the magnitude of hemodynamic effects of these agents and its contribution to proteinuria reduction has not been studied in humans. At the same time, it is not clear if treatment with blockers of the RAAS have similar renal hemodynamic effects in individuals with and without diabetes and kidney disease.
Up to 36 subjects with type 2 diabetes and more than 150 mg of proteinuria who are on stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) and up to 18 healthy volunteers will be enrolled in this study. Subjects with type 2 diabetes will be asked to stop their ACE inhibitor or ARB medications for 10 days. Between 7 to 10 days after stopping these medications renal blood flow (RBF) will be measured using contrast enhanced ultrasound (CEU) and urine protein will be measured as well for comparison to baseline. Subjects' ACE inhibitors or ARB will be restarted and RBF measurement using CEU and measurement of urine protein excretion will be repeated after 7 days. For comparison, RBF will be measured by CEU in up to 18 healthy volunteers. They will then be started on Lisinopril 10 mg orally once a day for 7 days. On day 7 RBF measurement will be repeated to assess the effect of ACE inhibitors on RBF in healthy individuals as compared to those with diabetic nephropathy.
- Conditions
- Type 2 Diabetes
- Being tested
- ACEI or ARB, Lisinopril
- Keywords
- Diabetic nephropathy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACEI or ARBDrug
Subjects will be asked to discontinue their usual ACE inhibitor or Angiotensin Receptor Blocker (ARB) for ten days, undergo a CEU using Definity (for renal blood flow assessment) as the contrast agent, then resume their usual ACEI or ARB for ten days, then undergo another CEU using Definity as the contrast agent.
LisinoprilDrug
Subjects will be undergo a CEU using Definity (for renal blood flow assessment) as the contrast agent, then take Lisinopril 10 mg every day for 7 days, after which they will undergo another CEU using Definity as the contrast agent.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with diabetic nephropathy | Experimental | Renal blood flow (RBF) will be measured using contrast enhanced ultrasound (CEU) and urine protein will be measured both on and off angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB). Receives: Drug: ACEI or ARB |
| Healthy volunteers | Active comparator | Renal blood flow (RBF) will be measured using contrast enhanced ultrasound (CEU) and urine protein will be measured both on and off angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB). Receives: Drug: Lisinopril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in renal blood flow (RBF)
We will use Contrast Enhanced Ultrasound using Definity as the contrast agent to monitor changes in renal blood flow (RBF).
Measured: Study day 10
Change in renal blood flow (RBF)
Measured: Compared to Study Day 17
Secondary outcomes (2)
Change in Proteinuria
Measured: Study day 10
Change in Proteinuria
Measured: Compared to study day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Slow Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kambiz Kalantarinia, University of Virginia
- Investigators
- Kambiz Kalantarinia, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101269
- Sponsor's protocol ID
- 14815
- Status last verified
- May 2017
- First submitted
- 6 Apr 2010
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Angiotensin Converting Enzyme Inhibitor, Lisinopril, on Renal Blood Flow and Its Correlation With Proteinuria Reduction in Subjects With Type 2 Diabetes and Kidney Disease (KXK005).
- ClinicalTrials.gov ID
- NCT01101269
- Acronym / sponsor ID
- 14815
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetic nephropathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Apr 2010 (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.
The purpose of the study is to investigate the effect of a blood pressure medication, Lisinopril, or similar drugs in that class, on the flow of blood to the kidneys. In this study, we will compare blood flow to the kidneys in healthy people that do not have diabetes or kidney disease with people that have diabetes and evidence of kidney disease.
Detailed description
Blockers of renin angiotensin aldosterone system (RAAS) are considered the standard of care in treatment of diabetic nephropathy. Their effects are thought to be through multiple mechanisms, including reducing intraglomerular pressure. However, due to the lack of a sensitive, practical and noninvasive method of monitoring renal hemodynamics, the magnitude of hemodynamic effects of these agents and its contribution to proteinuria reduction has not been studied in humans. At the same time, it is not clear if treatment with blockers of the RAAS have similar renal hemodynamic effects in individuals with and without diabetes and kidney disease.
Up to 36 subjects with type 2 diabetes and more than 150 mg of proteinuria who are on stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) and up to 18 healthy volunteers will be enrolled in this study. Subjects with type 2 diabetes will be asked to stop their ACE inhibitor or ARB medications for 10 days. Between 7 to 10 days after stopping these medications renal blood flow (RBF) will be measured using contrast enhanced ultrasound (CEU) and urine protein will be measured as well for comparison to baseline. Subjects' ACE inhibitors or ARB will be restarted and RBF measurement using CEU and measurement of urine protein excretion will be repeated after 7 days. For comparison, RBF will be measured by CEU in up to 18 healthy volunteers. They will then be started on Lisinopril 10 mg orally once a day for 7 days. On day 7 RBF measurement will be repeated to assess the effect of ACE inhibitors on RBF in healthy individuals as compared to those with diabetic nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with diabetic nephropathy | Experimental | Drug: ACEI or ARBRenal blood flow (RBF) will be measured using contrast enhanced ultrasound (CEU) and urine protein will be measured both on and off angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB). |
| Healthy volunteers | Active comparator | Drug: LisinoprilRenal blood flow (RBF) will be measured using contrast enhanced ultrasound (CEU) and urine protein will be measured both on and off angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults (ages 40 - 75 years)
- Diagnosis of type 2 diabetes for more than 5 years
- Evidence of diabetic nephropathy as evidenced by
- Treatment with a blocker of the renin -angiotensin-aldosterone system (either ACE inhibitor or ARB)
- For healthy controls,
Key exclusion criteria (16 listed)
- Type 1 diabetes
- Glomerular filtration rate less than 40 ml/min/1.73 m2 by MDRD formula
- Hemoglobin A1C greater than 10%
- Blood pressure greater than 150/90 mm Hg or less than 100/55 mm Hg
- History of kidney transplantation
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 |
|---|---|---|
| ACEI or ARBSubjects will be asked to discontinue their usual ACE inhibitor or Angiotensin Receptor Blocker (ARB) for ten days, undergo a CEU using Definity (for renal blood flow assessment) as the contrast agent, then resume their usual ACEI or ARB for ten days, then undergo another CEU using Definity as the contrast agent. | Drug | Subjects with diabetic nephropathy |
| LisinoprilSubjects will be undergo a CEU using Definity (for renal blood flow assessment) as the contrast agent, then take Lisinopril 10 mg every day for 7 days, after which they will undergo another CEU using Definity as the contrast agent. | Drug | Healthy volunteers |
Primary outcome
Change in renal blood flow (RBF)
Time frame: Study day 10
We will use Contrast Enhanced Ultrasound using Definity as the contrast agent to monitor changes in renal blood flow (RBF).
Change in renal blood flow (RBF)
Time frame: Compared to Study Day 17
2 secondary outcomes
Change in Proteinuria
Time frame: Study day 10
Change in Proteinuria
Time frame: Compared to study day 17
Results and safety
The study was stopped early (reason given: Slow Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
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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.
Kambiz Kalantarinia, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACEI or ARB and Lisinopril in people with Type 2 Diabetes, run by University of Virginia at 1 site in United States.
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 8 inclusion and 16 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: stopped early, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study was stopped early (reason given: Slow Recruitment). Results are not available in the source record.
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?
Change in renal blood flow (RBF) (time frame: Study day 10). The study lists 2 primary outcomes in all. 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 12 May 2017.