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NCT Number: NCT03386097

Interstitial Fluid in the Development of Cardiovascular Disease

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.

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Key information

Conditions

Type2 Diabetes Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ekerö Vårdcentral, Ekerö, Ekerö Kommun, Sweden

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of interstitial fluid, skin biopsies and blood

Other

Collection of interstitial fluid, skin biopsies and blood

Primary outcomes

  1. Interstitial fluid-to-serum ratio for LDL cholesterol

    Time frame: 2 hours

  2. Cholesterol level in skin biopsies

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2017
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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