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Trial record 2 of 809 for:    APOB

ApoB48 Metabolism in Plasma and Interstitial Fluid

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ClinicalTrials.gov Identifier: NCT03921203
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Mats Rudling, Karolinska University Hospital

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.


Condition or disease
Diabetes Mellitus, Type 2

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: ApoB48IC2 Metabolism in Plasma and Interstitial Fluid
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 31, 2021

Group/Cohort
Type 2 diabetes patients
Healthy controls



Primary Outcome Measures :
  1. ApoB48 levels in blood and interstitial fluid [ Time Frame: 7 hours ]

Biospecimen Retention:   Samples With DNA
Interstitial fluid and blood (serum, plasma and whole blood)


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy controls and type 2 diabetes patients over 18 years old, matched for age and gender.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921203


Contacts
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Contact: Mats Rudling +46 8585 869 55 mats.rudling@ki.se

Locations
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Sweden
Patient research centre, Clinic of endocrinology, Karolinska University Hospital Recruiting
Stockholm, Huddinge, Sweden, 14186
Contact: Viveca Åberg       viveca.aberg@ki.se   
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Mats Rudling Karolinska Institutet

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Responsible Party: Mats Rudling, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03921203     History of Changes
Other Study ID Numbers: ApoB48IC2
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases