Arginase Inhibition in Humans With Obesity

NCT05536934 | Completed Early Phase 1

• 1 other identifier: 2016/1173-32
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of arginase inhibition on endothelial function in humans with obesity.

Conditions

Obese; Endothelial Function

Outcome Measures

Primary Outcomes (1)

• 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.

  120 min intraarterial infusion of the arginase inhibitor nor-NOHA

Secondary Outcomes (1)

• Endothelium-independent change in forearm blood flow

  120 min intraarterial infusion of the arginase inhibitor nor-NOHA

Study Arms (1)

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

Drug: Nω-hydroxy-nor-arginine

Interventions

Nω-hydroxy-nor-arginine DRUG

Arginase inhibition

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \>35kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: September 13, 2022
• Study Start: December 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)