Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation

University of Missouri (MU)

Status and phase: Suspended; Early Phase 1

Conditions: Healthy; Vasodilation; Insulin Resistance; Obesity; Autonomic Dysfunction

Treatments: Other: Carbon dioxide breathing; Drug: Human insulin; Other: Neurovascular Coupling

Study type: Interventional

Funder types: Other

Identifiers

NCT05153395

2057288

Details and patient eligibility

About

The purpose of this project is to examine the impact of increases in brain insulin on sympathetic nervous system activity, as well as peripheral and cerebral blood flow in humans.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy adult men and women;
• 18-45 years of age;
• BMI >18 kg/m2;
• non-pregnant/non-breastfeeding;
• non-nicotine users;

Exclusion criteria

• taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic

Self-reported history of:

• hepatic, renal, pulmonary, cardiovascular, or neurological disease;
• stroke or neurovascular disease;
• bleeding/clotting disorders;
• sleep apnea or other sleep disorders;
• diabetes;
• smoking;
• history of alcoholism or substance abuse;
• hypertension;
• respiratory disease;
• active cancer;
• autoimmune disease.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

65 participants in 3 patient groups

Insulin (Doppler)

Experimental group

Description:

Human insulin (160 IU) will be administered as a bolus using an intra-nasal device.

Treatment:

Drug: Human insulin

Other: Neurovascular Coupling

Other: Carbon dioxide breathing

Insulin (MRI)

Experimental group

Description:

Human insulin (160 IU) will be administered as a bolus using an intra-nasal device.

Treatment:

Drug: Human insulin

Other: Carbon dioxide breathing

Time Control (Doppler)

Other group

Description:

Time control only

Treatment:

Other: Neurovascular Coupling

Other: Carbon dioxide breathing