ApoB48 Metabolism in Plasma and Interstitial Fluid

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

ApoB48IC2 Metabolism in Plasma and Interstitial Fluid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921203
• Other study ID #: ApoB48IC2
• Status: Completed
• Start date: April 17, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
Sweden	Patient research centre, Clinic of endocrinology, Karolinska University Hospital	Stockholm	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ApoB48 levels in blood and interstitial fluid		7 hours