NCT03380325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

December 8, 2017

Last Update Submit

July 15, 2019

Conditions

Diabetes Mellitus, Type 2Insulin Sensitivity/Resistance

Keywords

Capillary recruitment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Continous cardiovascular monitoring

    Before and during the clamp

  • Continous cardiovascular monitoring

    Before and during the clamp

  • Continous cardiovascular monitoring

    Before and during the clamp

  • Continous cardiovascular monitoring

    Before and during the clamp

  • Continous cardiovascular monitoring

    Before and during the clamp

  • +1 more secondary outcomes

Study Arms (2)

Iloprost first

EXPERIMENTAL

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

Drug: Iloprost infusion

Iloprost second

EXPERIMENTAL

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

Drug: Iloprost infusion

Interventions

Iloprost infusionDRUG

Iloprost is a stable prostacyclin analogue

Iloprost firstIloprost second

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Erik Serné, Dr.

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 8, 2017

First Posted

December 21, 2017

Study Start

May 11, 2016

Primary Completion

June 29, 2017

Study Completion

June 29, 2017

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations

NL(1)