Interstitial Fluid in the Development of Cardiovascular D... | NCT03386097

Studies
Interstitial Fluid in the Development of Cardiovascular Disease

NCT03386097

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

Sep 9, 2021Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Type2 Diabetes
Atherosclerosis

Interventions

Collection of interstitial fluid, skin biopsies and blood

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2018Actual

Primary Completion Date

Sep 3, 2021Actual

Completion Date

Sep 3, 2021Actual

First Submitted Date

Dec 21, 2017

First Submission Date that Met QC Criteria

Dec 21, 2017

First Posted Date

Dec 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2021

Last Update Posted Date

Sep 9, 2021Actual

Name	Class
Karolinska Institutet	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Type 2 diabetes patients			Other: Collection of interstitial fluid, skin biopsies and blood
Healthy controls			Other: Collection of interstitial fluid, skin biopsies and blood

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collection of interstitial fluid, skin biopsies and blood	Other	Collection of interstitial fluid, skin biopsies and blood	Healthy controls Type 2 diabetes patients

Measure	Description	Time Frame
Interstitial fluid-to-serum ratio for LDL cholesterol		2 hours
Cholesterol level in skin biopsies		30 minutes

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy controls and type 2 diabetes patients over 18 years old, matched for age and gender.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mats Rudling	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ekerö Vårdcentral		Ekerö	Ekerö Kommun	17831	Sweden
Patient research centre, Clinic of endocrinology, Karolinska University Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D050197	Atherosclerosis

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

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Browse Branches

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