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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Insulin Sensitivity/Resistance
• Intervention / Treatment: Drug: Iloprost infusion

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • VU University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iloprost first; Cross-over starts with iloprost intervention, then second clamp without iloprost.	Drug: Iloprost infusion; Iloprost is a stable prostacyclin analogue
Experimental: Iloprost second; Cross-over starts without iloprost intervention, then second clamp with iloprost.	Drug: Iloprost infusion; Iloprost is a stable prostacyclin analogue

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continous cardiovascular monitoring	Diastolic blood pressure	Before and during the clamp
Continous cardiovascular monitoring	Systolic blood pressure	Before and during the clamp
Continous cardiovascular monitoring	Cardiac output	Before and during the clamp
Continous cardiovascular monitoring	Heart rate	Before and during the clamp
Continous cardiovascular monitoring	Stroke volume	Before and during the clamp
Continous cardiovascular monitoring	Systemic vascular resistance	Before and during the clamp

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Investigators: Principal Investigator: Erik Serné, Dr., Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2016
• Primary Completion (Actual): June 29, 2017
• Study Completion (Actual): June 29, 2017

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Capillary recruitment
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperinsulinism; Hypersensitivity; Diabetes Mellitus, Type 2; Insulin Resistance; Vasodilator Agents; Platelet Aggregation Inhibitors; Iloprost
• Other Study ID Numbers: Bootcamp1