Arginase Inhibition in Type 1 and Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

The Effect of Arginase Inhibition on Vascular Endothelial Function in Patients With Type 1 and Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05806502
• Other study ID #: T1DM study
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of arginase inhibition on endothelial function in patients with type 1 diabetes and type 2 diabetes.

Description:

Detailed Description:

The study is performed on one group of patients with type 1 diabetes and one group of patients with type 2 diabetes.

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.

Twelve subjects are included in each group. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes

• Type 2 diabetes

Exclusion Criteria:

• Age >80 years

• Acute coronary or ischemic event during the last three months

• Vascular surgery of the arm

• Peripheral vascular disease affecting the arm

• Ongoing anticoagulant medication

• Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Diagnostic Test:
• N?-hydroxy-nor-arginine
Arginase inhibitor

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelium-dependant increase in forearm blood flow	Change in forearm blood flow	120 minutes