ApoB48 Metabolism in Plasma and Interstitial Fluid

NCT ID: NCT03921203

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-17
• Study Completion Date: 2022-12-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Type 2 diabetes patients

No interventions assigned to this group

Healthy controls

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mats Rudling

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mats Rudling

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Patient research centre, Clinic of endocrinology, Karolinska University Hospital

Stockholm, Huddinge, Sweden

Countries

Sweden

Other Identifiers

ApoB48IC2

Identifier Type: -

Identifier Source: org_study_id