ApoB48 Metabolism in Plasma and Interstitial Fluid

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT03921203
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-17
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-19
• Primary Completion: 2021-12-01
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ApoB48 levels in blood and interstitial fluid	7 hours

Trial Locations

Locations (1)

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