Novel Treatment for Brain Insulin Resistance and Hypoperfusion
Overview
- Phase
- Early Phase 1
- Intervention
- Carbon dioxide breathing
- Conditions
- Healthy
- Sponsor
- University of Missouri-Columbia
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Amount of cerebral blood flow
- Status
- Suspended
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Investigators
Jacqueline K Limberg, PhD
Associate Professor
University of Missouri-Columbia
Eligibility Criteria
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;
- •history of alcoholism or substance abuse;
- •hypertension;
- •respiratory disease;
Arms & Interventions
Insulin (Doppler)
Human insulin (160 IU) will be administered as a bolus using an intra-nasal device.
Intervention: Carbon dioxide breathing
Insulin (Doppler)
Human insulin (160 IU) will be administered as a bolus using an intra-nasal device.
Intervention: Neurovascular Coupling
Insulin (Doppler)
Human insulin (160 IU) will be administered as a bolus using an intra-nasal device.
Intervention: Human insulin
Insulin (MRI)
Human insulin (160 IU) will be administered as a bolus using an intra-nasal device.
Intervention: Carbon dioxide breathing
Insulin (MRI)
Human insulin (160 IU) will be administered as a bolus using an intra-nasal device.
Intervention: Human insulin
Time Control (Doppler)
Time control only
Intervention: Carbon dioxide breathing
Time Control (Doppler)
Time control only
Intervention: Neurovascular Coupling
Outcomes
Primary Outcomes
Amount of cerebral blood flow
Time Frame: Change from baseline at minute 15
Measured with trans-cranial Doppler ultrasound (cm/s) or arterial spin labeling (mL/100 g/min)
Secondary Outcomes
- Amount of leg blood flow(Change from baseline at minute 15)
- Amount of muscle sympathetic nerve activity (MSNA)(Change from baseline at minute 15)