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Completed

NCT Number: NCT03921203

ApoB48 Metabolism in Plasma and Interstitial Fluid

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Patient research centre, Clinic of endocrinology, Karolinska University Hospital

Stockholm, Huddinge, 14186, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. ApoB48 levels in blood and interstitial fluid

    Time frame: 7 hours

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

ApoB48IC2 Metabolism in Plasma and Interstitial Fluid

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 19, 2019
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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