Diabetes Mellitus, Type 2NCT03921216
Cholesterol Metabolism in Plasma and Interstitial Fluid Among Subjects Undergoing Hemodialysis.
An observational study of Diabetes Mellitus, Type 2 and Diabetic Nephropathies, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Because the atherosclerosis process partly occur in the intercellular space of the vessel wall, the determination of the constitution of lipoproteins in the interstitial fluid may expand the knowledge about the atherosclerosis process and lead to a better understanding of what constitutes the increased risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Nephropathies, Chronic Kidney Diseases
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 17 Apr 2019to 31 Dec 2027
- Phase
- Observational
- 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
Study population: Diabetic nephropathy, because of type 2 diabetes, undergoing hemodialysis and subjects with chronic kidney disease of other causes undergoing hemodialysis.
Who may be able to join
- Diabetic nephropathy, because of type 2 diabetes, undergoing hemodialysis and subjects with chronic kidney disease of other causes undergoing hemodialysis.
Who cannot join
- Active infection that increases the risk of secondary infection in the skin where the vesicles containing interstitial fluid have been emptied of interstitial fluid with a fine needle and the bladder roof is intact.
- Treatment with Warfarin due to increased risk of Calciphylaxis (calcific uremic arteriolopathy, CUA)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dialysis Unit, M87-89, Karolinska University Hospital, Huddinge
Stockholm, 14186
About this study
Because the atherosclerosis process partly occur in the intercellular space of the vessel wall, the determination of the constitution of lipoproteins in the interstitial fluid may expand the knowledge about the atherosclerosis process and lead to a better understanding of what constitutes the increased risk of developing cardiovascular disease in patients with chronic diseases. The investigators hypothesize that the apoB-containing particles in T2D patients are more susceptible to be retained or consumed in the intercellular compartment, which in turn could be one explanation for the elevated risk of atherosclerosis. The investigators hypothesise that with the progression of chronic kidney disease this process is further increased. Patients undergoing dialysis are known to have a very high risk of cardiovascular disease. The investigators now want to study the cholesterol metabolism in interstitial fluid in subjects undergoing hemodialysis because of diabetic nephropathy and in subjects undergoing hemodialysis because of chronic kidney disease of other causes.
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic nephropathy, on hemodialysis | Not described | |
| Chronic kidney disease, on hemodialysis | Chronic kidney disease of other causes than Diabetes. | |
| Chronic kidney disease, predialysis | Renal outpatients at Nephrology Unit, Karolinska University Hospital Huddinge | |
| Diabetic nephropathy, predialysis | Renal outpatients at Nephrology Unit, Karolinska University Hospital Huddinge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial fluid-to-serum ratio for LDL cholesterol
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start17 Apr 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Covid19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Karolinska 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mats Rudling, Karolinska University Hospital
- Investigators
- Mats Rudling, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921216
- Sponsor's protocol ID
- CKDIC2
- Status last verified
- Mar 2025
- First submitted
- 17 Apr 2019
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholesterol Metabolism in Plasma and Interstitial Fluid Among Subjects Undergoing Hemodialysis.
- ClinicalTrials.gov ID
- NCT03921216
- Acronym / sponsor ID
- CKDIC2
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Covid19
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Apr 2019 (actual)
- 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.
Because the atherosclerosis process partly occur in the intercellular space of the vessel wall, the determination of the constitution of lipoproteins in the interstitial fluid may expand the knowledge about the atherosclerosis process and lead to a better understanding of what constitutes the increased risk of developing cardiovascular disease in patients with chronic diseases. The investigators hypothesize that the apoB-containing particles in T2D patients are more susceptible to be retained or consumed in the intercellular compartment, which in turn could be one explanation for the elevated risk of atherosclerosis. The investigators hypothesise that with the progression of chronic kidney disease this process is further increased. Patients undergoing dialysis are known to have a very high risk of cardiovascular disease. The investigators now want to study the cholesterol metabolism in interstitial fluid in subjects undergoing hemodialysis because of diabetic nephropathy and in subjects undergoing hemodialysis because of chronic kidney disease of other causes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diabetic nephropathy, on hemodialysis | – | – |
| Chronic kidney disease, on hemodialysis | – | –Chronic kidney disease of other causes than Diabetes. |
| Chronic kidney disease, predialysis | – | –Renal outpatients at Nephrology Unit, Karolinska University Hospital Huddinge |
| Diabetic nephropathy, predialysis | – | –Renal outpatients at Nephrology Unit, Karolinska University Hospital Huddinge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic nephropathy, because of type 2 diabetes, undergoing hemodialysis and subjects with chronic kidney disease of other causes undergoing hemodialysis.
Key inclusion criteria (1 listed)
- Diabetic nephropathy, because of type 2 diabetes, undergoing hemodialysis and subjects with chronic kidney disease of other causes undergoing hemodialysis.
Key exclusion criteria (2 listed)
- Active infection that increases the risk of secondary infection in the skin where the vesicles containing interstitial fluid have been emptied of interstitial fluid with a fine needle and the bladder roof is intact.
- Treatment with Warfarin due to increased risk of Calciphylaxis (calcific uremic arteriolopathy, CUA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interstitial fluid-to-serum ratio for LDL cholesterol
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Mats Rudling principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Diabetic Nephropathies, run by Karolinska University Hospital at 1 site in Sweden.
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 1 inclusion and 2 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: paused, as of the sponsor's last update on 19 Mar 2025. 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 Sweden. 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?
Interstitial fluid-to-serum ratio for LDL cholesterol (time frame: 2 hours). 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 19 Mar 2025.