NCT00184821

Brief Summary

In this proof-of-concept study, forearm vulnerability to ischemic exercise is studied in patients with type 1 diabetes mellitus with and without prior ischemic preconditioning (short period of ischemia that protects against subsequent ischemic exercise). Annexin A5 scintigraphy is used to quantify subtle signs of mild and reversible forearm injury that results from ischemic exercise. The following hypotheses are tested:

  1. 1.Patients with type 1 diabetes are not more vulnerable to ischemic injury as compared with previously studied healthy volunteers.
  2. 2.Ischemic preconidtioning is still present in patients with type 1 diabetes. Depending on the validity of hypothesis 2, the effect of short pharmacological interventions are studied on vulnerability to forearm ischemia/reperfusion injury in the absence or presence of local forearm ischemic preconditioning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2004

Shorter than P25 for all trials

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

June 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

April 5, 2007

Status Verified

April 1, 2007

First QC Date

September 9, 2005

Last Update Submit

April 4, 2007

Conditions

Diabetes Mellitus, Insulin-DependentIschemia-Reperfusion Injury

Keywords

DiabetesIschemiaAnnexin A5 scintigraphy

Interventions

Ischemic preconditioningPROCEDURE
Forearm ischemic exercisePROCEDURE
Annexin A5 scintigraphyPROCEDURE
DiazoxideDRUG
glibenclamideDRUG
adenosineDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • type 1 diabetes mellitus
  • age 18-50 years

You may not qualify if:

  • hypertension (systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg
  • cardiovascular disease (coronary artery insufficiency,CVA/TIA, peripheral artery disease
  • HbA1c \> 9%
  • Body Mass Index \< 25 kg/m2
  • Unable to stop co-medication (other than insulin) for 1 week
  • Previous exposure to radiation (diagnostic or therapeutic) in the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Centre Nijmegen; Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (1)

  • Engbersen R, Riksen NP, Mol MJ, Bravenboer B, Boerman OC, Meijer P, Oyen WJ, Tack C, Rongen GA, Smits P. Improved resistance to ischemia and reperfusion, but impaired protection by ischemic preconditioning in patients with type 1 diabetes mellitus: a pilot study. Cardiovasc Diabetol. 2012 Oct 10;11:124. doi: 10.1186/1475-2840-11-124.

    PMID: 23051145DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Reperfusion InjuryDiabetes MellitusIschemia

Interventions

Ischemic PreconditioningDiazoxideGlyburideAdenosine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative TechniquesBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSulfonylurea CompoundsUreaAmidesPurine NucleosidesPurinesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Richard Engbersen, MD

    Radboud University Nijmegen Medical Centre; department of Pharmacology-Toxicology

    STUDY CHAIR

  • Gerard Rongen, MD, PhD

    Radboud University Nijmegen Medical Centre; Department of Pharmacology-Toxicology

    STUDY CHAIR

  • Wim Oyen, MD, PhD

    Radboud University Nijmegen Medical Centre; Department of Nuclear Medicine

    STUDY CHAIR

  • Marc Mol, MD, PhD

    Canisius Wilhelmina Ziekenhuis Nijmegen; Department of Internal Medicine

    STUDY CHAIR

  • Paul Smits, MD, PhD

    Radboud University Nijmegen Medical Centre; Department of Pharmacology-Toxicology

    PRINCIPAL INVESTIGATOR

  • B. Bravenboer, MD, PhD

    Catharina Hospital Eindhoven, Dept. of Internal Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

June 1, 2004

Study Completion

May 1, 2005

Last Updated

April 5, 2007

Record last verified: 2007-04

Locations

NL(1)