ApoB48 Metabolism in Plasma and Interstitial Fluid

ApoB48IC2 Metabolism in Plasma and Interstitial Fluid

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03921203

Enrollment

Registered

2019-04-19

Start date

2019-04-17

Completion date

2022-12-31

Last updated

2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
ApoB48 levels in blood and interstitial fluid	7 hours

Countries

Sweden

Outcome results