Interstitial Fluid in the Development of Cardiovascular Disease

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386097
• Other study ID #: DiabetesIC2
• Status: Completed
• Start date: January 10, 2018
• Est. completion date: September 3, 2021

Study information

• Verified date: September 2021
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 3, 2021
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Type2 Diabetes

Intervention

Other:
• Collection of interstitial fluid, skin biopsies and blood
Collection of interstitial fluid, skin biopsies and blood

Locations

Country	Name	City	State
Sweden	Ekerö Vårdcentral	Ekerö	Ekerö Kommun
Sweden	Patient research centre, Clinic of endocrinology, Karolinska University Hospital	Huddinge	Stockholm
Sweden	GIH (gymnastik och idrottshögskolan)	Stockholm
Sweden	Stiftelsen Stockholms Sjukhems Husläkarmottagning	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interstitial fluid-to-serum ratio for LDL cholesterol		2 hours
Primary	Cholesterol level in skin biopsies		30 minutes