The Effect of Iloprost on Capillary Recruitment and Insulin Sensitivity in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Insulin Sensitivity/Resistance
• Interventions: Drug: Iloprost infusion

• Registration Number: NCT03380325
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

This study examines the effects of iloprost - a stable prostacyclin analogue - on insulin-mediated muscle capillary recruitment and whole-body glucose uptake in a cross-over design.

Detailed Description

In type 2 diabetes impaired insulin-mediated muscle perfusion is thought to contribute to reduced whole-body glucose uptake. This study aims to identify iloprost - a stable prostacyclin analogue - as a possible therapeutic option to increase whole-body glucose uptake via enhancement of muscle perfusion.

All participants will be subjected to two hyperinsulinemic-euglycemic clamps; one with and one without simultaneous iloprost infusion in a randomized cross-over design. Microvascular blood volume will be measured by means of contrast-enhanced ultrasonography.

Study Timeline

• Study Start: 2016-05-11
• Primary Completion: 2017-06-29
• Study Completion: 2017-06-29
• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-21
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Type 2 diabetes
• Male or female (post-menopausal)
• Age above 45 years and below 70 years
• BMI >30 kg/m2
• HbA1c < 80 mmol/mol or < 8,6% Subjects must use metformin
• Stable medication use
• Stable tension regulation (with or without medication)
• Subjects should be able to give informed consent

Exclusion Criteria

• A history of cardiovascular event (Cerebrovascular event, myocardial infarction or pacemaker implantation)
• Severe-very severe lung emphysema (GOLD stage III-IV)
• Use of any antibiotics or proton pump inhibitor (PPI) in the past three months
• Use of any other antidiabetic medication besides metformin (e.g. SU-derivates, insulin)
• Use of a platelet inhibitor or cumarin derivate during
• Subjects participated in a lifestyle programme in the past 6 months (diet or exercise)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Iloprost first	Iloprost infusion	Cross-over starts with iloprost intervention, then second clamp without iloprost.
Iloprost second	Iloprost infusion	Cross-over starts without iloprost intervention, then second clamp with iloprost.

Primary Outcome Measures

Name	Time	Method
Rate of disappearance	During the clamp	Glucose uptake in peripheral tissues during hyperinsulinemic euglycemic clamp
Capillary recruitment	Before and during the clamp	Change in skeletal muscle en myocardial microvascular blood volume upon insulin infusion

Secondary Outcome Measures

Name	Time	Method
Continous cardiovascular monitoring	Before and during the clamp	Systemic vascular resistance

Trial Locations

Locations (1)

VU University Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands