MODULATION OF POSTPRANDIAL LIPEMIA, INFLAMMATION, AND VASCULAR FUNCTION BY PCSK9 INHIBITION IN DIABETES.

Phase 4

Completed

• Conditions: fat loading; Postprandial lipemia; 10018424; 10013317; 10003216

• Registration Number: NL-OMON43374
• Lead Sponsor: Sint Franciscus Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-11-07
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

- Age of 18 years or older
- Male
- Fasting triglycerides levels between 1.8 mmol/L and 7.0 mmol/L
- Diabetes mellitus type 2 on intensive insulin treatment (three times short acting and one daily long acting) (unchanges for >10 weeks prior to consent)
- Stable glucose regulation last 6 months (HbA1c >6.5% - < <9.0%)
- Stable lipid lowering therapy last 2 months (no changes in regiments or dose)

Exclusion Criteria

- Current smoking
- Impaired renalfunction (MDRD <60 ml/min/1.73 m2)
- Recent cardiovascular event (<6 months) (myocardial infarction, coronary artery bypass grafting, stroke)
- Severe hyperglycemic events in the past 6 months (hyperglycemia >20 mmol/L requiring hospital admittance)
- Recent or current use of pcsk9 antibodies
- HIV-infection
- Uncontrolled hypothyroidism

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Postprandial leukocyte inflammation markers</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Postprandial lipemia, oxidative stress parameters and vascular function.</p><br>