Type2 DiabetesNCT03386097
Interstitial Fluid in the Development of Cardiovascular Disease
An observational study of Type2 Diabetes and Atherosclerosis, run by Karolinska University Hospital at 4 sites in Sweden.
Trial summary
At a given level of serum cholesterol, patients with T2D have an increased risk of developing atherosclerosis compared with nondiabetic subjects. In a previous study we showed that the interstitial fluid-to-serum gradient of LDL and VLDL cholesterol is reduced in T2D patients compared with healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes, Atherosclerosis
- What is being tested?
- Collection of interstitial fluid, skin biopsies and blood
- How many people
- 100 participants
- Where
- 4 sitesSweden
- Study dates
- 10 Jan 2018to 3 Sep 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls and type 2 diabetes patients over 18 years old, matched for age and gender.
Who may be able to join
- Over 18 years.
- For the T2D study group: Diagnosed with type 2 diabetes.
Who cannot join
- For subjects with type 2 diabetes:
- Systemic inflammatory disease that requires active treatment
- Thyroid disease that requires active treatment
- Skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated
- Treatment with oral glucocorticoids
- Levels of SR, TSH, T4 or Hemoglobin in the blood pronouncedly outside the reference range
Show all 13Show fewer
- Pregnancy
- For healthy controls:
- Registered disease in the health declaration that requires continuous systemic treatment. Exception to the above: well controlled hypertension in which case the subject should not have treatment with more than one antihypertensive drug, the drug must not be an alpha-blocker or beta-blocker or thiazide diuretic
- Skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated
- Blood pressure pronouncedly above 140/90
- Blood test results pronouncedly outside the reference range
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Ekerö Vårdcentral
Ekerö, Ekerö Kommun, 17831
Patient research centre, Clinic of endocrinology, Karolinska University Hospital
Huddinge, Stockholm County, 14186
Stiftelsen Stockholms Sjukhems Husläkarmottagning
Stockholm, 11219
GIH (gymnastik och idrottshögskolan)
Stockholm, 11433
About this study
Official title: Studies of the Importance of Interstitial Fluid in the Development of Cardiovascular Disease, an Expanded Study.
At a given level of serum cholesterol, patients with T2D have an increased risk of developing atherosclerosis compared with nondiabetic subjects.
In a previous study we showed that the interstitial fluid-to-serum gradient of LDL and VLDL cholesterol is reduced in T2D patients compared with healthy controls. This was not found for HDL cholesterol. However, the cholesterol transporting function of HDL particles from interstitial fluid from patients with T2D were lower than in healthy controls. We hypothesize that that the apo B-containing particles in T2D patients are more susceptible to be retained or consumed in the extravascular space.
We are to study if skin biopsies from T2D patients contain more cholesterol than biopsies from healthy controls. We hypothesize that samples from T2D patients are richer in cholesterol, which could explain why VLDL and LDL cholesterol are lower in relation to their plasma levels in T2D.
- Conditions
- Type2 Diabetes, Atherosclerosis
- Being tested
- Collection of interstitial fluid, skin biopsies and blood
- Keywords
- Cholesterol, Interstitial fluid
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of interstitial fluid, skin biopsies and bloodOther
Collection of interstitial fluid, skin biopsies and blood
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes patients | Not described Receives: Other: Collection of interstitial fluid, skin biopsies and blood | |
| Healthy controls | Not described Receives: Other: Collection of interstitial fluid, skin biopsies and blood |
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
Cholesterol level in skin biopsies
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start10 Jan 2018
- Primary completion3 Sep 2021
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies 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
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Mats Rudling, Karolinska University Hospital
- Investigators
- Mats Rudling, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386097
- Sponsor's protocol ID
- DiabetesIC2
- Status last verified
- Sep 2021
- First submitted
- 21 Dec 2017
- Last updated
- 9 Sep 2021
- 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 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of the Importance of Interstitial Fluid in the Development of Cardiovascular Disease, an Expanded Study.
- ClinicalTrials.gov ID
- NCT03386097
- Acronym / sponsor ID
- DiabetesIC2
- Conditions
- Type2 Diabetes, Atherosclerosis
- Keywords
- Cholesterol, Interstitial fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 29 Dec 2017 (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.
At a given level of serum cholesterol, patients with T2D have an increased risk of developing atherosclerosis compared with nondiabetic subjects.
In a previous study we showed that the interstitial fluid-to-serum gradient of LDL and VLDL cholesterol is reduced in T2D patients compared with healthy controls. This was not found for HDL cholesterol. However, the cholesterol transporting function of HDL particles from interstitial fluid from patients with T2D were lower than in healthy controls. We hypothesize that that the apo B-containing particles in T2D patients are more susceptible to be retained or consumed in the extravascular space.
We are to study if skin biopsies from T2D patients contain more cholesterol than biopsies from healthy controls. We hypothesize that samples from T2D patients are richer in cholesterol, which could explain why VLDL and LDL cholesterol are lower in relation to their plasma levels in T2D.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes patients | – | Other: Collection of interstitial fluid, skin biopsies and blood |
| Healthy controls | – | Other: Collection of interstitial fluid, skin biopsies and blood |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls and type 2 diabetes patients over 18 years old, matched for age and gender.
Key inclusion criteria (2 listed)
- Over 18 years.
- For the T2D study group: Diagnosed with type 2 diabetes.
Key exclusion criteria (13 listed)
- Systemic inflammatory disease that requires active treatment
- Thyroid disease that requires active treatment
- Skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated
- Treatment with oral glucocorticoids
- Levels of SR, TSH, T4 or Hemoglobin in the blood pronouncedly outside the reference range
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 |
|---|---|---|
| Collection of interstitial fluid, skin biopsies and bloodCollection of interstitial fluid, skin biopsies and blood | Other | Healthy controls, Type 2 diabetes patients |
Primary outcome
Interstitial fluid-to-serum ratio for LDL cholesterol
Time frame: 2 hours
Cholesterol level in skin biopsies
Time frame: 30 minutes
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 9 Sep 2021.
- 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes and Atherosclerosis, run by Karolinska University Hospital at 4 sites 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 2 inclusion and 13 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 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Interstitial fluid-to-serum ratio for LDL cholesterol (time frame: 2 hours). 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 9 Sep 2021.