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

NCT ID: NCT03380325

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-11

Study Completion Date

2017-06-29

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2 Insulin Sensitivity/Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iloprost first

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

Group Type EXPERIMENTAL

Iloprost infusion

Intervention Type DRUG

Iloprost is a stable prostacyclin analogue

Iloprost second

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

Group Type EXPERIMENTAL

Iloprost infusion

Intervention Type DRUG

Iloprost is a stable prostacyclin analogue

Interventions

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Iloprost infusion

Iloprost is a stable prostacyclin analogue

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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Erik Serne

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik Serné, Dr.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

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VU University Medical Center

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Bootcamp1

Identifier Type: -

Identifier Source: org_study_id

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