Type 2 Diabetes MellitusPhase 1/2NCT02687152
Arginase Inhibition and Microvascular Endothelial Function in Type 2 Diabetes
A Phase 1/2 study testing N-hydroxy-nor-L-arginine in people with Type 2 Diabetes Mellitus, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The present project is designed to test the hypothesis that arginase contributes to microvascular endothelial dysfunction in patients with type 2 diabetes and microvascular complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- N-hydroxy-nor-L-arginine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2014to Jan 2016
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 2 diabetes mellitus and microvascular dysfunction defined as microalbuminuria > 3.0 mg/mmol or presence of retinopathy.
Who cannot join
- Myocardial infarction or unstable angina within the last three months,
- Changed dose of any vasodilator drug during the preceding six weeks,
- Ongoing treatment with warfarin
- Concomitant disease that may have interfered with the possibility for the patients to comply with or complete the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Arginase Inhibition on Microvascular Endothelial Function in Patients With Type 2 Diabetes and Microvascular Dysfunction.
The present project is designed to test the hypothesis that arginase contributes to microvascular endothelial dysfunction in patients with type 2 diabetes and microvascular complications.
Read the detailed description
Background
The development of microvascular complications in diabetes is a complex process, in which endothelial dysfunction is of importance. Emerging evidence suggests that arginase is a key mediator of endothelial dysfunction in type 2 diabetes mellitus (T2DM) by reciprocally regulating nitric oxide bioavailability. The aim of this study was to test the hypothesis that arginase activity is increased and that arginase contributes to microvascular endothelial function in patients with T2DM and microvascular dysfunction.
Method
Microvascular endothelium-dependent and -independent vasodilatation are investigated in patients with T2DM (n =12) and healthy age-matched control subjects (n =12) with laser-Doppler flowmetry during iontophoretic application of acetylcholine and sodium nitroprusside, respectively, before and after intra-arterial administration of the arginase inhibitor N-hydroxy-nor-L-arginine (0.1 mg/min) for 120 min.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- N-hydroxy-nor-L-arginine
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-hydroxy-nor-L-arginineOther
| Study group | Role | What they receive |
|---|---|---|
| Arginase inhibition | Experimental | N-hydroxyl-nor-L-arginine, i.a. 0.1 mg/min for 120 min Receives: Other: N-hydroxy-nor-L-arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cutaneous microvascular endothelial function
Laser Doppler flow rate
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startMar 2014
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Pernow, Karolinska Institutet
- Investigators
- John Pernow, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687152
- Sponsor's protocol ID
- Micro Arginase
- Status last verified
- Feb 2016
- First submitted
- 9 Feb 2016
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Arginase Inhibition on Microvascular Endothelial Function in Patients With Type 2 Diabetes and Microvascular Dysfunction.
- ClinicalTrials.gov ID
- NCT02687152
- Acronym / sponsor ID
- Micro Arginase
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Feb 2016 (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.
The present project is designed to test the hypothesis that arginase contributes to microvascular endothelial dysfunction in patients with type 2 diabetes and microvascular complications.
Detailed description
Background
The development of microvascular complications in diabetes is a complex process, in which endothelial dysfunction is of importance. Emerging evidence suggests that arginase is a key mediator of endothelial dysfunction in type 2 diabetes mellitus (T2DM) by reciprocally regulating nitric oxide bioavailability. The aim of this study was to test the hypothesis that arginase activity is increased and that arginase contributes to microvascular endothelial function in patients with T2DM and microvascular dysfunction.
Method
Microvascular endothelium-dependent and -independent vasodilatation are investigated in patients with T2DM (n =12) and healthy age-matched control subjects (n =12) with laser-Doppler flowmetry during iontophoretic application of acetylcholine and sodium nitroprusside, respectively, before and after intra-arterial administration of the arginase inhibitor N-hydroxy-nor-L-arginine (0.1 mg/min) for 120 min.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arginase inhibition | Experimental | Other: N-hydroxy-nor-L-arginineN-hydroxyl-nor-L-arginine, i.a. 0.1 mg/min for 120 min |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of type 2 diabetes mellitus and microvascular dysfunction defined as microalbuminuria > 3.0 mg/mmol or presence of retinopathy.
Key exclusion criteria (4 listed)
- Myocardial infarction or unstable angina within the last three months,
- Changed dose of any vasodilator drug during the preceding six weeks,
- Ongoing treatment with warfarin
- Concomitant disease that may have interfered with the possibility for the patients to comply with or complete the study protocol
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 |
|---|---|---|
| N-hydroxy-nor-L-arginine | Other | Arginase inhibition |
Primary outcome
Change in cutaneous microvascular endothelial function
Time frame: 2 hours
Laser Doppler flow rate
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 22 Feb 2016.
- Individual participant dataSharing planned: No
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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.
John Pernow, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing N-hydroxy-nor-L-arginine in people with Type 2 Diabetes Mellitus, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 4 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 22 Feb 2016. 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 Sweden. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Change in cutaneous microvascular endothelial function (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2016.