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

Primary Purpose

Diabetes Mellitus, Type 2, Insulin Sensitivity/Resistance

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Iloprost infusion
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Capillary recruitment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • VU University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Iloprost first

Iloprost second

Arm Description

Cross-over starts with iloprost intervention, then second clamp without iloprost.

Cross-over starts without iloprost intervention, then second clamp with iloprost.

Outcomes

Primary Outcome Measures

Rate of disappearance
Glucose uptake in peripheral tissues during hyperinsulinemic euglycemic clamp
Capillary recruitment
Change in skeletal muscle en myocardial microvascular blood volume upon insulin infusion

Secondary Outcome Measures

Continous cardiovascular monitoring
Diastolic blood pressure
Continous cardiovascular monitoring
Systolic blood pressure
Continous cardiovascular monitoring
Cardiac output
Continous cardiovascular monitoring
Heart rate
Continous cardiovascular monitoring
Stroke volume
Continous cardiovascular monitoring
Systemic vascular resistance

Full Information

First Posted
December 8, 2017
Last Updated
July 15, 2019
Sponsor
Amsterdam UMC, location VUmc
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1. Study Identification

Unique Protocol Identification Number
NCT03380325
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 11, 2016 (Actual)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
June 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Insulin Sensitivity/Resistance
Keywords
Capillary recruitment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iloprost first
Arm Type
Experimental
Arm Description
Cross-over starts with iloprost intervention, then second clamp without iloprost.
Arm Title
Iloprost second
Arm Type
Experimental
Arm Description
Cross-over starts without iloprost intervention, then second clamp with iloprost.
Intervention Type
Drug
Intervention Name(s)
Iloprost infusion
Intervention Description
Iloprost is a stable prostacyclin analogue
Primary Outcome Measure Information:
Title
Rate of disappearance
Description
Glucose uptake in peripheral tissues during hyperinsulinemic euglycemic clamp
Time Frame
During the clamp
Title
Capillary recruitment
Description
Change in skeletal muscle en myocardial microvascular blood volume upon insulin infusion
Time Frame
Before and during the clamp
Secondary Outcome Measure Information:
Title
Continous cardiovascular monitoring
Description
Diastolic blood pressure
Time Frame
Before and during the clamp
Title
Continous cardiovascular monitoring
Description
Systolic blood pressure
Time Frame
Before and during the clamp
Title
Continous cardiovascular monitoring
Description
Cardiac output
Time Frame
Before and during the clamp
Title
Continous cardiovascular monitoring
Description
Heart rate
Time Frame
Before and during the clamp
Title
Continous cardiovascular monitoring
Description
Stroke volume
Time Frame
Before and during the clamp
Title
Continous cardiovascular monitoring
Description
Systemic vascular resistance
Time Frame
Before and during the clamp

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Serné, Dr.
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU University Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands

12. IPD Sharing Statement

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

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