Interstitial Fluid in the Development of Cardiovascular Disease

NCT ID: NCT03386097

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2021-09-03

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.

Conditions

Type2 Diabetes; Atherosclerosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Type 2 diabetes patients

Collection of interstitial fluid, skin biopsies and blood

Intervention Type: OTHER

Collection of interstitial fluid, skin biopsies and blood

Healthy controls

Collection of interstitial fluid, skin biopsies and blood

Intervention Type: OTHER

Collection of interstitial fluid, skin biopsies and blood

Interventions

Collection of interstitial fluid, skin biopsies and blood

Collection of interstitial fluid, skin biopsies and blood

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mats Rudling

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mats Rudling

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Ekerö Vårdcentral

Ekerö, Ekerö Kommun, Sweden

Patient research centre, Clinic of endocrinology, Karolinska University Hospital

Huddinge, Stockholm County, Sweden

Stiftelsen Stockholms Sjukhems Husläkarmottagning

Stockholm, , Sweden

GIH (gymnastik och idrottshögskolan)

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

DiabetesIC2

Identifier Type: -

Identifier Source: org_study_id