DiabetesNCT00175734
Interactive Studies of Endstage Diabetic Dialysis Patients
A study testing High Hemoglobin Concentration and Low Hemoglobin Concentration in people with Diabetes, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients. Hypothesis: The expansile capacity of blood vessels is affected by different hemoglobin concentrations in diabetic hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- High Hemoglobin Concentration and Low Hemoglobin Concentration
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetics and non-diabetics on hemodialysis
- On erythropoietin and iron
- On a statin
Who cannot join
- Uncontrolled blood pressure (BP)
- Ulcers
- Amputations
- Unstable cardiac function
- Malignancy
- Planned operations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Studies in Vascular Reactivity and Anemia Correction Therapy in Endstage Kidney Disease Patients
The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.
Hypothesis: The expansile capacity of blood vessels is affected by different hemoglobin concentrations in diabetic hemodialysis patients.
Read the detailed description
Vascular disease is an important cause of morbidity and mortality in patients with chronic kidney disease (CKD), of which a large proportion is diabetic. Diabetics have complex and multiple reasons for vascular disease, and there is accumulating evidence of associated poor endothelial cell function, particularly in those with kidney disease. One important mechanism through which this might occur relates to changes in shear rate and stress resulting from different viscosity levels. Such fluctuations are increasingly recognized to affect endothelial cell function and hence vessel-wall adaptability in both the short and long term.
Little is known of the consequence of different shear effects on endothelial cell function at various hemoglobin levels in kidney disease. There is some evidence to suggest however that, in the presence of micro-vascular disease, a relative anemia, with associated lower viscosity and shear stress, may be of benefit compared to higher hemoglobin levels.
Diabetics account for almost 40% of dialysis patients worldwide, and are the fastest growing component of the epidemic of CKD. Thus, an understanding of optimal treatment targets for anemia therapy, and the impact of different target levels of hemoglobin on vascular wall function is imperative.
- Conditions
- Diabetes
- Being tested
- High Hemoglobin Concentration, Low Hemoglobin Concentration
- Keywords
- Vascular Reactivity, Anemia Correction Therapy, Hemodialysis patients, Diabetic and non-diabetic patients, Diabetes in Hemodialysis patients
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Hemoglobin ConcentrationProcedure or surgery
The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.
Low Hemoglobin ConcentrationProcedure or surgery
The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine what hemoglobin level is best for diabetic dialysis patients. Specific parameters: endothelial cell function and related expansile capacity of blood vessels. *Assessed through labs and pulse wave velocity test
Measured: 8-12 months per participant
Secondary outcomes (1)
Pulse rate, BP, respiratory rate, peripheral oxygen saturation, ECG during 6-min walk-test and Health Related Quality of Life Assessment as measured by questionnaires
Measured: 8-12 months per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionDec 2007
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeera Levin, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175734
- Sponsor's protocol ID
- P04-0007
- Status last verified
- Jan 2013
- First submitted
- 13 Sep 2005
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Studies in Vascular Reactivity and Anemia Correction Therapy in Endstage Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT00175734
- Acronym / sponsor ID
- P04-0007
- Conditions
- Diabetes
- Keywords
- Vascular Reactivity, Anemia Correction Therapy, Hemodialysis patients, Diabetic and non-diabetic patients, Diabetes in Hemodialysis patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Sep 2005 (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 this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.
Hypothesis: The expansile capacity of blood vessels is affected by different hemoglobin concentrations in diabetic hemodialysis patients.
Detailed description
Vascular disease is an important cause of morbidity and mortality in patients with chronic kidney disease (CKD), of which a large proportion is diabetic. Diabetics have complex and multiple reasons for vascular disease, and there is accumulating evidence of associated poor endothelial cell function, particularly in those with kidney disease. One important mechanism through which this might occur relates to changes in shear rate and stress resulting from different viscosity levels. Such fluctuations are increasingly recognized to affect endothelial cell function and hence vessel-wall adaptability in both the short and long term.
Little is known of the consequence of different shear effects on endothelial cell function at various hemoglobin levels in kidney disease. There is some evidence to suggest however that, in the presence of micro-vascular disease, a relative anemia, with associated lower viscosity and shear stress, may be of benefit compared to higher hemoglobin levels.
Diabetics account for almost 40% of dialysis patients worldwide, and are the fastest growing component of the epidemic of CKD. Thus, an understanding of optimal treatment targets for anemia therapy, and the impact of different target levels of hemoglobin on vascular wall function is imperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetics and non-diabetics on hemodialysis
- On erythropoietin and iron
- On a statin
Key exclusion criteria (6 listed)
- Uncontrolled blood pressure (BP)
- Ulcers
- Amputations
- Unstable cardiac function
- Malignancy
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 |
|---|---|---|
| High Hemoglobin ConcentrationThe purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients. | Procedure or surgery | – |
| Low Hemoglobin ConcentrationThe purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients. | Procedure or surgery | – |
Primary outcome
To determine what hemoglobin level is best for diabetic dialysis patients. Specific parameters: endothelial cell function and related expansile capacity of blood vessels. *Assessed through labs and pulse wave velocity test
Time frame: 8-12 months per participant
1 secondary outcome
Pulse rate, BP, respiratory rate, peripheral oxygen saturation, ECG during 6-min walk-test and Health Related Quality of Life Assessment as measured by questionnaires
Time frame: 8-12 months per participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
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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.
Adeera Levin principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Hemoglobin Concentration and Low Hemoglobin Concentration in people with Diabetes, run by University of British Columbia at 1 site in Canada.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Feb 2013. 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 Canada. 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?
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?
To determine what hemoglobin level is best for diabetic dialysis patients. Specific parameters: endothelial cell function and related expansile capacity of blood vessels. *Assessed through labs and pulse wave velocity test (time frame: 8-12 months per participant). 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 1 Feb 2013.