Clinical trial NCT03380325: The Effect of Iloprost on Capillary Recruitment and Insulin Sensitivity in Type 2 Diabetes
Official title: The Effects of Iloprost Infusion on Capillary Recruitment and Whole-body Glucose Uptake in Type 2 Diabetic Patients - a Cross-over Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Insulin Sensitivity/Resistance
Keywords: Capillary recruitment
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of disappearance
timeFrame: During the clamp
measure: Capillary recruitment
timeFrame: Before and during the clamp
Secondary outcomes:
measure: Continous cardiovascular monitoring
timeFrame: Before and during the clamp
measure: Continous cardiovascular monitoring
timeFrame: Before and during the clamp
measure: Continous cardiovascular monitoring
timeFrame: Before and during the clamp
measure: Continous cardiovascular monitoring
timeFrame: Before and during the clamp
measure: Continous cardiovascular monitoring
timeFrame: Before and during the clamp
measure: Continous cardiovascular monitoring
timeFrame: Before and during the clamp
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Erik Serné, Dr.
role: PRINCIPAL_INVESTIGATOR
References: