Clinical trial NCT03386097: Interstitial Fluid in the Development of Cardiovascular Disease
Official title: Studies of the Importance of Interstitial Fluid in the Development of Cardiovascular Disease, an Expanded Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes
Atherosclerosis
Keywords: Cholesterol
Interstitial fluid
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2017-12-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy controls and type 2 diabetes patients over 18 years old, matched for age and gender.

Brief 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. 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.


Eligibility criteria: Inclusion criteria:

* Over 18 years.
* For the T2D study group: Diagnosed with type 2 diabetes.

Exclusion criteria:

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
* 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

Primary outcomes:
measure: Interstitial fluid-to-serum ratio for LDL cholesterol
timeFrame: 2 hours
measure: Cholesterol level in skin biopsies
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ekerö
country: Sweden
facility: Ekerö Vårdcentral
state: Ekerö Kommun
city: Huddinge
country: Sweden
facility: Patient research centre, Clinic of endocrinology, Karolinska University Hospital
state: Stockholm
city: Stockholm
country: Sweden
facility: Stiftelsen Stockholms Sjukhems Husläkarmottagning
city: Stockholm
country: Sweden
facility: GIH (gymnastik och idrottshögskolan)
Study officials:
affiliation: Karolinska Institutet
name: Mats Rudling
role: PRINCIPAL_INVESTIGATOR
References: