Interstitial Fluid in the Development of Cardiovascular Disease

Completed

• Conditions: Type2 Diabetes; Atherosclerosis
• Interventions: Other: Collection of interstitial fluid, skin biopsies and blood

• Registration Number: NCT03386097
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-29
• Study Start: 2018-01-10
• Status Verified: 2021-09
• Primary Completion: 2021-09-03
• Study Completion: 2021-09-03
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 2 diabetes patients	Collection of interstitial fluid, skin biopsies and blood	-
Healthy controls	Collection of interstitial fluid, skin biopsies and blood	-

Primary Outcome Measures

Name	Time	Method
Interstitial fluid-to-serum ratio for LDL cholesterol	2 hours
Cholesterol level in skin biopsies	30 minutes

Trial Locations

Locations (4)

Ekerö Vårdcentral; 🇸🇪 Ekerö, Ekerö Kommun, Sweden

Stiftelsen Stockholms Sjukhems Husläkarmottagning; 🇸🇪 Stockholm, Sweden

Patient research centre, Clinic of endocrinology, Karolinska University Hospital; 🇸🇪 Huddinge, Stockholm, Sweden

GIH (gymnastik och idrottshögskolan); 🇸🇪 Stockholm, Sweden