Diabetes Mellitus, Insulin-DependentNCT00184821
Ischemic Injury and Ischemic Preconditioning in Diabetes
An observational study of Diabetes Mellitus, Insulin-Dependent and Ischemia-Reperfusion Injury, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Diabetes Mellitus, Insulin-Dependent, Ischemia-Reperfusion Injury
- What is being tested?
- Ischemic preconditioning, Forearm ischemic exercise and Annexin A5 scintigraphy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2004to May 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- type 1 diabetes mellitus
- age 18-50 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Clinical Research Centre Nijmegen; Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Acute Local Ischemic Preconditioning in Patients With Type 1 Diabetes in Vivo
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:
- Patients with type 1 diabetes are not more vulnerable to ischemic injury as compared with previously studied healthy volunteers.
- 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.
Read the detailed description
All patients will be studied in supine position after an overnight fast, while plasma glucose levels are monitored. In the first 8 patients intravenous insulin is administered as needed, to reach target glucose levels between 5-7 mmol/l. Patients will be subjected to 10 minutes of forearm ischemia (non-dominant arm), combined with handgripping at 50% of maximal force until exhaustion. Upon reperfusion, Tc-99m-HYNIC-Annexin A5 will be injected intravenously. Targeting of annexin A5 to thenar muscle and forearm flexor muscle will be quantified as the percentage difference in radioactivity between experimental and control side. This procedure will be performed twice (randomized cross-over design), with at least 2 week interval, either with or without 10 minutes ischemia followed by 10 minutes of reperfusion prior to ischemic exercise.
Depending on the results of this study, substudies will be performed to study the effect of diazoxide (K-ATP channel opener, may mimic ischemic preconditioning), glibenclamide (K-ATP channel blocker, may inhibit ischemic preconditioning) or adenosine (infusion into brachial artery of non-dominant arm as a substitute for ischemic preconditioning).
- Being tested
- Ischemic preconditioning, Forearm ischemic exercise, Annexin A5 scintigraphy, Diazoxide, glibenclamide
- Keywords
- Diabetes, Ischemia, Annexin A5 scintigraphy
- Medical subject headings
- Diabetes Mellitus, Type 1, Reperfusion Injury, Diabetes Mellitus, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic preconditioningProcedure or surgery
Forearm ischemic exerciseProcedure or surgery
Annexin A5 scintigraphyProcedure or surgery
DiazoxideDrug
glibenclamideDrug
adenosineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Insulin-DependentStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Diabetes Fund
- Investigators
- Richard Engbersen, MD, Study chair, Radboud University Nijmegen Medical Centre; department of Pharmacology-ToxicologyGerard Rongen, MD, PhD, Study chair, Radboud University Nijmegen Medical Centre; Department of Pharmacology-ToxicologyWim Oyen, MD, PhD, Study chair, Radboud University Nijmegen Medical Centre; Department of Nuclear MedicineMarc Mol, MD, PhD, Study chair, Canisius Wilhelmina Ziekenhuis Nijmegen; Department of Internal MedicinePaul Smits, MD, PhD, Principal investigator, Radboud University Nijmegen Medical Centre; Department of Pharmacology-ToxicologyB. Bravenboer, MD, PhD, Study chair, Catharina Hospital Eindhoven, Dept. of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184821
- Sponsor's protocol ID
- QKF03-diab
- Other IDs
- 2004.11.022
- Status last verified
- Apr 2007
- First submitted
- 9 Sep 2005
- Last updated
- 5 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23051145
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Local Ischemic Preconditioning in Patients With Type 1 Diabetes in Vivo
- ClinicalTrials.gov ID
- NCT00184821
- Acronym / sponsor ID
- QKF03-diab
- Keywords
- Diabetes, Ischemia, Annexin A5 scintigraphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Diabetes Fund
- Study start
- Jun 2004
- Study completion
- May 2005 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients with type 1 diabetes are not more vulnerable to ischemic injury as compared with previously studied healthy volunteers.
- 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.
Detailed description
All patients will be studied in supine position after an overnight fast, while plasma glucose levels are monitored. In the first 8 patients intravenous insulin is administered as needed, to reach target glucose levels between 5-7 mmol/l. Patients will be subjected to 10 minutes of forearm ischemia (non-dominant arm), combined with handgripping at 50% of maximal force until exhaustion. Upon reperfusion, Tc-99m-HYNIC-Annexin A5 will be injected intravenously. Targeting of annexin A5 to thenar muscle and forearm flexor muscle will be quantified as the percentage difference in radioactivity between experimental and control side. This procedure will be performed twice (randomized cross-over design), with at least 2 week interval, either with or without 10 minutes ischemia followed by 10 minutes of reperfusion prior to ischemic exercise.
Depending on the results of this study, substudies will be performed to study the effect of diazoxide (K-ATP channel opener, may mimic ischemic preconditioning), glibenclamide (K-ATP channel blocker, may inhibit ischemic preconditioning) or adenosine (infusion into brachial artery of non-dominant arm as a substitute for ischemic preconditioning).
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- type 1 diabetes mellitus
- age 18-50 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic preconditioning | Procedure or surgery | – |
| Forearm ischemic exercise | Procedure or surgery | – |
| Annexin A5 scintigraphy | Procedure or surgery | – |
| Diazoxide | Drug | – |
| glibenclamide | Drug | – |
| adenosine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2007.
- Derived from this study: PubMed 23051145Engbersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Engbersen, MD study chair
Radboud University Nijmegen Medical Centre; department of Pharmacology-Toxicology
Gerard Rongen, MD, PhD study chair
Radboud University Nijmegen Medical Centre; Department of Pharmacology-Toxicology
Wim Oyen, MD, PhD study chair
Radboud University Nijmegen Medical Centre; Department of Nuclear Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Insulin-Dependent and Ischemia-Reperfusion Injury, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2007.