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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380325
• Other study ID #: Bootcamp1
• Status: Completed
• Phase: N/A
• Start date: May 11, 2016
• Est. completion date: June 29, 2017

Study information

• Verified date: July 2019
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 29, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity/Resistance

Intervention

Drug:
• Iloprost infusion
Iloprost is a stable prostacyclin analogue

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of disappearance	Glucose uptake in peripheral tissues during hyperinsulinemic euglycemic clamp	During the clamp
Primary	Capillary recruitment	Change in skeletal muscle en myocardial microvascular blood volume upon insulin infusion	Before and during the clamp
Secondary	Continous cardiovascular monitoring	Diastolic blood pressure	Before and during the clamp
Secondary	Continous cardiovascular monitoring	Systolic blood pressure	Before and during the clamp
Secondary	Continous cardiovascular monitoring	Cardiac output	Before and during the clamp
Secondary	Continous cardiovascular monitoring	Heart rate	Before and during the clamp
Secondary	Continous cardiovascular monitoring	Stroke volume	Before and during the clamp
Secondary	Continous cardiovascular monitoring	Systemic vascular resistance	Before and during the clamp