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Interstitial Fluid in the Development of Cardiovascular Disease

Studies of the Importance of Interstitial Fluid in the Development of Cardiovascular Disease, an Expanded Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03386097
Enrollment
100
Registered
2017-12-29
Start date
2018-01-10
Completion date
2021-09-03
Last updated
2021-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Type2 Diabetes

Keywords

Cholesterol, Interstitial fluid

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.

Interventions

OTHERCollection of interstitial fluid, skin biopsies and blood

Collection of interstitial fluid, skin biopsies and blood

Sponsors

Karolinska Institutet
CollaboratorOTHER
Karolinska University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Interstitial fluid-to-serum ratio for LDL cholesterol2 hours
Cholesterol level in skin biopsies30 minutes

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026