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

A

Amsterdam UMC, location VUmc

Status

Completed

Conditions

Insulin Sensitivity/Resistance
Diabetes Mellitus, Type 2

Treatments

Drug: Iloprost infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT03380325
Bootcamp1

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Iloprost first
Experimental group
Description:
Cross-over starts with iloprost intervention, then second clamp without iloprost.
Treatment:
Drug: Iloprost infusion
Iloprost second
Experimental group
Description:
Cross-over starts without iloprost intervention, then second clamp with iloprost.
Treatment:
Drug: Iloprost infusion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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