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Completed

NCT Number: NCT03380325

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU University Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Iloprost infusion

Drug

Iloprost is a stable prostacyclin analogue

Primary outcomes

  1. Rate of disappearance

    Time frame: During the clamp

    Glucose uptake in peripheral tissues during hyperinsulinemic euglycemic clamp

  2. Capillary recruitment

    Time frame: Before and during the clamp

    Change in skeletal muscle en myocardial microvascular blood volume upon insulin infusion

Secondary outcomes

  1. Continous cardiovascular monitoring

    Time frame: Before and during the clamp

    Diastolic blood pressure

  2. Continous cardiovascular monitoring

    Time frame: Before and during the clamp

    Systolic blood pressure

  3. Continous cardiovascular monitoring

    Time frame: Before and during the clamp

    Cardiac output

  4. Continous cardiovascular monitoring

    Time frame: Before and during the clamp

    Heart rate

  5. Continous cardiovascular monitoring

    Time frame: Before and during the clamp

    Stroke volume

  6. Continous cardiovascular monitoring

    Time frame: Before and during the clamp

    Systemic vascular resistance

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

The Effects of Iloprost Infusion on Capillary Recruitment and Whole-body Glucose Uptake in Type 2 Diabetic Patients - a Cross-over Trial.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 21, 2017
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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