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Interstitial Fluid in the Development of Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT03386097
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Mats Rudling, 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.


Condition or disease Intervention/treatment
Type2 Diabetes Atherosclerosis Other: Collection of interstitial fluid, skin biopsies and blood

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Studies of the Importance of Interstitial Fluid in the Development of Cardiovascular Disease, an Expanded Study.
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Type 2 diabetes patients Other: Collection of interstitial fluid, skin biopsies and blood
Collection of interstitial fluid, skin biopsies and blood

Healthy controls Other: Collection of interstitial fluid, skin biopsies and blood
Collection of interstitial fluid, skin biopsies and blood




Primary Outcome Measures :
  1. Interstitial fluid-to-serum ratio for LDL cholesterol [ Time Frame: 2 hours ]
  2. Cholesterol level in skin biopsies [ Time Frame: 30 minutes ]

Biospecimen Retention:   Samples With DNA
Interstitial fluid, skin biopsies and blood (serum, plasma and whole blood)


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy controls and type 2 diabetes patients over 18 years old, matched for age and gender.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386097


Contacts
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Contact: Mats Rudling +46 8585 869 55 mats.rudling@ki.se

Locations
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Sweden
Ekerö Vårdcentral Recruiting
Ekerö, Ekerö Kommun, Sweden, 17831
Contact: Viveca Åberg       viveca.aberg@ki.se   
Patient research centre, Clinic of endocrinology, Karolinska University Hospital Recruiting
Huddinge, Stockholm, Sweden, 14186
Contact: Viveca Åberg       viveca.aberg@ki.se   
Stiftelsen Stockholms Sjukhems Husläkarmottagning Recruiting
Stockholm, Sweden, 11219
Contact: Viveca Åberg       viveca.aberg@ki.se   
GIH (gymnastik och idrottshögskolan) Recruiting
Stockholm, Sweden, 11433
Contact: Eva Andersson    0046(0)739460034      
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
Investigators
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Principal Investigator: Mats Rudling Karolinska Institutet

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Responsible Party: Mats Rudling, Professor, MD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03386097     History of Changes
Other Study ID Numbers: DiabetesIC2
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mats Rudling, Karolinska University Hospital:
Cholesterol
Interstitial fluid
Additional relevant MeSH terms:
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Atherosclerosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases