ApoB48 Metabolism in Plasma and Interstitial Fluid

NCT03921203 | Completed

• 1 other identifier: ApoB48IC2
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• ApoB48 levels in blood and interstitial fluid

  7 hours

Study Arms (2)

Type 2 diabetes patients

Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy controls and type 2 diabetes patients over 18 years old, matched for age and gender.

You may qualify if:

• Over 18 years.
• For the T2D study group: Diagnosed with type 2 diabetes.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Patient research centre, Clinic of endocrinology, Karolinska University Hospital

Stockholm, Huddinge, 14186, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Interstitial fluid and blood (serum, plasma and whole blood)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mats Rudling

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 19, 2019
• Study Start: April 17, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2022
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

SE (1)