ObeseEarly Phase 1NCT05536934
Arginase Inhibition in Humans With Obesity
A Early Phase 1 study testing Nω-hydroxy-nor-arginine in people with Obese and Endothelial Function, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
To evaluate the efficacy of arginase inhibition on endothelial function in humans with obesity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obese, Endothelial Function
- What is being tested?
- Nω-hydroxy-nor-arginine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2016to Mar 2022
- Phase
- Early Phase 1
- 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
- BMI >35kg/m2
Who cannot join
- Age >80 years. Type 2 diabetes defined as >7 mmol/L in fasting plasma glucose or >11 mmol/L following 2h of oral glycemic load.
- Myocardial infarction/unstable angina within 6 weeks prior to the study. Treatment with oral anticoagulants (Warfarin or New oral anticoagulants), Raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm.
- Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol.
- Participant in an ongoing study. Unwillingness to participate following oral and written information.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Karolinska University Hospital
Stockholm, 17176
About this study
Official title: Arginase Inhibition and Endothelial Function in Humans With Obesity
To evaluate the efficacy of arginase inhibition on endothelial function in humans with obesity.
Read the detailed description
The study is performed on one group of subjects with body mass index >35 and the absence of type 2 diabetes.
Inclusion criteria:
Body mass index >35 kg/m2.
Exclusion criteria:
Age >80 years. Type 2 diabetes defined as >7 mmol/L in fasting plasma glucose or >11 mmol/L following 2h of oral glycemic load.
Myocardial infarction/unstable angina within 6 weeks prior to the study. Treatment with oral anticoagulants (Warfarin or New oral anticoagulants), Raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm.
Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol.
Participant in an ongoing study. Unwillingness to participate following oral and written information.
Forearm blood flow is determined by venous occlusion plethysmography. Endothelium-dependent vasodilatation is determined during intra-brachial artery infusion of serotonin (21, 70 and 210 ng/min). Endothelium-independent vasodilatation is determined by infusion of sodium nitroprusside (SNP; 1, 3 and 10 µg/min). Each dose is given for 2 min at a rate of 2.5 ml/min. Data are expressed as percentage change in forearm blood from baseline flow.
Fifteen subjects are included. On the day of the study the subject arrives to the laboratory after having a light breakfast. Forearm vessels of the non-dominant arm are cannulated and forearm blood flow is determined as described above. Baseline endothelium-dependent and endothelium-independent vasodilatation is determined by intra-arterial infusions of serotonin and SNP, respectively. Thereafter an intra-arterial infusion of the arginase inhibitor N-omega-hydroxy-nor-l-arginine (nor-NOHA) is administered as an intra-arterial infusion at a rate of 0.1 mg/min and is maintained for 120 min. The dose is based on a previous study by our group demonstrating improved endothelial function. Endothelium-dependent and -independent vasodilatation is reassessed at 120 min of infusion.
- Conditions
- Obese, Endothelial Function
- Being tested
- Nω-hydroxy-nor-arginine
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nω-hydroxy-nor-arginineDrug
| Study group | Role | What they receive |
|---|---|---|
| Arginase inhibition | Experimental | Endothelium dependent and -independent vasodilatation before and after 120min intra-arterial administration of arginase the inhibitor N-omega-hydroxy-nor-l-arginine (nor-NOHA) is started and is maintained for 120 min at a rate of 0.1 mg/min Receives: Drug: Nω-hydroxy-nor-arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelium-dependent change in forearm blood flow
Percentage change in forearm blood flow from baseline induced by the endothelium-dependent vasodilator serotonin during arginase blockade vs. saline.
Measured: 120 min intraarterial infusion of the arginase inhibitor nor-NOHA
Secondary outcomes (1)
Endothelium-independent change in forearm blood flow
Percentage change in forearm blood flow from baseline induced by the endothelium-independent vasodilator nitroprusside during arginase blockade vs. saline.
Measured: 120 min intraarterial infusion of the arginase inhibitor nor-NOHA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study startDec 2016
- Primary completionSep 2021
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Pernow, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536934
- Sponsor's protocol ID
- 2016/1173-32
- Status last verified
- Sep 2022
- First submitted
- 21 Aug 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arginase Inhibition and Endothelial Function in Humans With Obesity
- ClinicalTrials.gov ID
- NCT05536934
- Acronym / sponsor ID
- 2016/1173-32
- Conditions
- Obese, Endothelial Function
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 13 Sep 2022 (actual)
- 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.
To evaluate the efficacy of arginase inhibition on endothelial function in humans with obesity.
Detailed description
The study is performed on one group of subjects with body mass index >35 and the absence of type 2 diabetes.
Inclusion criteria:
Body mass index >35 kg/m2.
Exclusion criteria:
Age >80 years. Type 2 diabetes defined as >7 mmol/L in fasting plasma glucose or >11 mmol/L following 2h of oral glycemic load.
Myocardial infarction/unstable angina within 6 weeks prior to the study. Treatment with oral anticoagulants (Warfarin or New oral anticoagulants), Raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm.
Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol.
Participant in an ongoing study. Unwillingness to participate following oral and written information.
Forearm blood flow is determined by venous occlusion plethysmography. Endothelium-dependent vasodilatation is determined during intra-brachial artery infusion of serotonin (21, 70 and 210 ng/min). Endothelium-independent vasodilatation is determined by infusion of sodium nitroprusside (SNP; 1, 3 and 10 µg/min). Each dose is given for 2 min at a rate of 2.5 ml/min. Data are expressed as percentage change in forearm blood from baseline flow.
Fifteen subjects are included. On the day of the study the subject arrives to the laboratory after having a light breakfast. Forearm vessels of the non-dominant arm are cannulated and forearm blood flow is determined as described above. Baseline endothelium-dependent and endothelium-independent vasodilatation is determined by intra-arterial infusions of serotonin and SNP, respectively. Thereafter an intra-arterial infusion of the arginase inhibitor N-omega-hydroxy-nor-l-arginine (nor-NOHA) is administered as an intra-arterial infusion at a rate of 0.1 mg/min and is maintained for 120 min. The dose is based on a previous study by our group demonstrating improved endothelial function. Endothelium-dependent and -independent vasodilatation is reassessed at 120 min of infusion.
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 | Drug: Nω-hydroxy-nor-arginineEndothelium dependent and -independent vasodilatation before and after 120min intra-arterial administration of arginase the inhibitor N-omega-hydroxy-nor-l-arginine (nor-NOHA) is started and is maintained for 120 min at a rate of 0.1 mg/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)
- BMI >35kg/m2
Key exclusion criteria (4 listed)
- Age >80 years. Type 2 diabetes defined as >7 mmol/L in fasting plasma glucose or >11 mmol/L following 2h of oral glycemic load.
- Myocardial infarction/unstable angina within 6 weeks prior to the study. Treatment with oral anticoagulants (Warfarin or New oral anticoagulants), Raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm.
- Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol.
- Participant in an ongoing study. Unwillingness to participate following oral and written information.
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 |
|---|---|---|
| Nω-hydroxy-nor-arginine | Drug | Arginase inhibition |
Primary outcome
Endothelium-dependent change in forearm blood flow
Time frame: 120 min intraarterial infusion of the arginase inhibitor nor-NOHA
Percentage change in forearm blood flow from baseline induced by the endothelium-dependent vasodilator serotonin during arginase blockade vs. saline.
1 secondary outcome
Endothelium-independent change in forearm blood flow
Time frame: 120 min intraarterial infusion of the arginase inhibitor nor-NOHA
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 13 Sep 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nω-hydroxy-nor-arginine in people with Obese and Endothelial Function, 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 13 Sep 2022. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Endothelium-dependent change in forearm blood flow (time frame: 120 min intraarterial infusion of the arginase inhibitor nor-NOHA). 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 13 Sep 2022.