ApoB48 Metabolism in Plasma and Interstitial Fluid

Sponsor

Karolinska University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03921203

Collaborator

(none)

Enrollment

Location

32.5

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Postprandial increases in the levels of atherogenic chylomicron remnant lipoprotein particles have long been considered a presumable risk factor for the development of atherosclerosis with time, also in normolipidemic subjects. apoB-48 (Chylomicron) in blood is a specific marker for intestinal derived lipoproteins. Specific aim: To determine if apoB-48 containing lipoproteins may appear in IC in the postprandial state after a standard meal and investigate the effect fasting and feeding have on levels of lipids, apolipoproteins and the cholesterol component of lipoproteins in IF and plasma.

Methodology: Intercellular fluid will be collected using the cup technique. IF will be collected in intervals corresponding to different periods after food intake. The IF from these different occasions will then be analysed and compared using FPLC and Elisa.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

ApoB48IC2 Metabolism in Plasma and Interstitial Fluid

Actual Study Start Date :

Apr 17, 2019

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Type 2 diabetes patients
Healthy controls

Outcome Measures

Primary Outcome Measures

ApoB48 levels in blood and interstitial fluid [7 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Patient research centre, Clinic of endocrinology, Karolinska University Hospital	Stockholm	Huddinge	Sweden	14186

Sponsors and Collaborators

Karolinska University Hospital

Investigators

Principal Investigator: Mats Rudling, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mats Rudling, Professor, Karolinska University Hospital

ClinicalTrials.gov Identifier:

NCT03921203

Other Study ID Numbers:

ApoB48IC2

First Posted:

Apr 19, 2019

Last Update Posted:

May 28, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of May 28, 2021