End-Stage Kidney DiseasePhase 4NCT02009514
Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients
A Phase 4 study testing Glucose-containing compared to glucose-free hemodialysate in people with End-Stage Kidney Disease and Type 2 Diabetes Mellitus, run by Tampere University Hospital.
Trial summary
The purpose of this study is to investigate differences in glycemia during the whole hemodialysis day and the whole freeday during hemodialysis, during the evening and the night after hemodialysis and at the same time intervals during the freeday in an unselected type 2 diabetic patient group using both… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Kidney Disease, Type 2 Diabetes Mellitus
- What is being tested?
- Glucose-containing compared to glucose-free hemodialysate
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Mar 2004
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetic patient
- undergoing stable intermittent thrice weekly hemodialysis for at least one month
Who cannot join
- None
About this study
Official title: Glucose Control During Glucose Containing And Glucose Free Hemodialysate Evaluated By Continuous Glucose Monitoring In Type 2 Diabetic Patients
The purpose of this study is to investigate differences in glycemia
- during the whole hemodialysis day and the whole freeday
- during hemodialysis, during the evening and the night after hemodialysis and at the same time intervals during the freeday in an unselected type 2 diabetic patient group using both glucose-containing and glucose-free dialysate.
- Conditions
- End-Stage Kidney Disease, Type 2 Diabetes Mellitus
- Being tested
- Glucose-containing compared to glucose-free hemodialysate
- Keywords
- Hemodialysis, Continuous glucose monitoring, Hypoglycemia, Hyperglycemia
- Medical subject headings
- Kidney Failure, Chronic, Diabetes Mellitus, Type 2, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose-containing compared to glucose-free hemodialysateOther
Also called Glucose-containing dialysate SK-F 219/1, Glucose-free dialysate SK-F 207
Comparison of effects on glucose variation
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose below 4.0 mmol/l
In the end of a two-week glucose-containing and glucose-free period percentage of hypoglycemic values of continuous glucose monitoring during the whole hemodialysis day is compared to the whole freeday. Similar comparison is made between the whole glucose-containing and the whole glucose-free hemodialysis day as well as between the whole glucose-containing and the whole glucose-free freeday.
Measured: In the end of a two week period
Secondary outcomes (1)
Glucose below 4.0 mmol/l during specified time intervals
Percentage of hypoglycemia during the specified time intervals is compared within the glucose-containing and glucose-free hemodialysis day and freeday, and between the glucose-containing and glucose-free hemodialysis day and the freeday. Lastly comparisons are made between the glucose-containing and glucose-free hemodialysis day, and between the glucose-containing and glucose-free freeday.
Measured: In the end of a two-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startOct 2002
- Primary completionFeb 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasi I Nevalainen, MD, Tampere University Hospital
- Investigators
- Pasi I Nevalainen, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009514
- Sponsor's protocol ID
- R02058M
- Status last verified
- Jan 2020
- First submitted
- 3 Dec 2013
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Control During Glucose Containing And Glucose Free Hemodialysate Evaluated By Continuous Glucose Monitoring In Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02009514
- Acronym / sponsor ID
- R02058M
- Conditions
- End-Stage Kidney Disease, Type 2 Diabetes Mellitus
- Keywords
- Hemodialysis, Continuous glucose monitoring, Hypoglycemia, Hyperglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Feb 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 12 Dec 2013 (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 investigate differences in glycemia
- during the whole hemodialysis day and the whole freeday
- during hemodialysis, during the evening and the night after hemodialysis and at the same time intervals during the freeday in an unselected type 2 diabetic patient group using both glucose-containing and glucose-free dialysate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (2 listed)
- type 2 diabetic patient
- undergoing stable intermittent thrice weekly hemodialysis for at least one month
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Glucose-containing compared to glucose-free hemodialysateAlso: Glucose-containing dialysate SK-F 219/1, Glucose-free dialysate SK-F 207Comparison of effects on glucose variation | Other | – |
Primary outcome
Glucose below 4.0 mmol/l
Time frame: In the end of a two week period
In the end of a two-week glucose-containing and glucose-free period percentage of hypoglycemic values of continuous glucose monitoring during the whole hemodialysis day is compared to the whole freeday. Similar comparison is made between the whole glucose-containing and the whole glucose-free hemodialysis day as well as between the whole glucose-containing and the whole glucose-free freeday.
1 secondary outcome
Glucose below 4.0 mmol/l during specified time intervals
Time frame: In the end of a two-week period
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 22 Jan 2020.
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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.
Pasi I Nevalainen, MD principal investigator
Tampere University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucose-containing compared to glucose-free hemodialysate in people with End-Stage Kidney Disease and Type 2 Diabetes Mellitus, run by Tampere University Hospital.
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 2 inclusion and 1 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 22 Jan 2020. 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?
Glucose below 4.0 mmol/l (time frame: In the end of a two week period). 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 22 Jan 2020.