The effect of vildagliptin on endothelium-dependent vasodilatation. A double blind, cross-over study in type 2 diabetes mellitus.

Phase 3

Completed

• Conditions: endothelial function; Endothelium-dependent vasodilatation; 10012653; 10003216

• Registration Number: NL-OMON32871
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

- type 2 diabetes
- age 35-75 years
- metformin monotherapy or combination therapy
- HbA1c < 8.0%

Exclusion Criteria

- Renal disease defined as creatinine level > 130 umol/l
- Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
- Current use of acetylsalicylic acid or vitamine K antagonists
- History of smoking within the past year
- History of or current abuse of drugs or alcohol
- History of heartfailure (NYHA class III or IV)
- Abnormalities on ECG that might interfere with current study protocol
- Pregnancy or breastfeeding
- Inability to understand the nature and extent of the trial and procedures required
- Presence of any medical condition that might interfere with the current study protocol
- Participation in a drug trial within 60 days prior to the first dose

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Forearm vasodilatory response to increasing doses of intra-arterially<br /><br>administered acetylcholine and sodium nitroprusside (three doses each)<br /><br>following 4 week treatment with vildagliptin and acarbose.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Signs of vascular inflammation following treatment with both vildagliptin and<br /><br>acarbose, assessed by<br /><br>• Cytokines (Il-6, hsCRP, Il-18)<br /><br>• Adipokines<br /><br><br /><br>Local effects on fat tissue following treatment with both vildagliptin and<br /><br>acarbose, assessed by<br /><br>• Fat cell size and morphology<br /><br>• Gene expression of GLUT4, adiponectin, PPAR&gamma;, Il-1&beta; and Il-18<br /><br><br /><br>Changes in ex vivo mononuclear cell responses to various stimuli following<br /><br>treatment with both vildagliptin and acarbose</p><br>