Intranasal Insulin for Insulin Resistance
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you do not take any medications that affect metabolic, respiratory, cardiovascular, or autonomic functions. If your current medications fall into these categories, you may need to stop taking them to participate.
What data supports the effectiveness of intranasal insulin therapy for insulin resistance?
The research shows that human insulin, when injected subcutaneously (under the skin), is effective in controlling blood sugar levels in diabetic patients, suggesting its potential usefulness in managing insulin resistance. However, there is no direct evidence from the provided studies about the effectiveness of intranasal insulin specifically for insulin resistance.12345
Is intranasal insulin generally safe for humans?
Research on human insulin, including various formulations like Humulin R and Novolin R, shows it is generally safe for humans, with no significant safety concerns reported in clinical trials. Some studies noted minor issues like insulin hypertrophy (localized swelling) in a few patients, but overall, human insulin is considered safe.12367
How is intranasal insulin different from other drugs for insulin resistance?
Intranasal insulin is unique because it is administered through the nose, allowing it to directly affect brain insulin signaling without causing the peripheral side effects typically associated with insulin injections. This non-invasive approach is particularly novel as it targets insulin resistance in the brain, which is linked to both metabolic and cognitive disorders.158910
What is the purpose of this trial?
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.
Research Team
Jacqueline K Limberg, Ph.D.
Principal Investigator
University of Missouri-Columbia
Eligibility Criteria
This trial is for healthy adults aged 18-45, with a BMI of 18-30 kg/m2 who don't smoke or use nicotine and are not pregnant or breastfeeding. It's not suitable for those with respiratory, metabolic, cardiovascular, autonomic diseases, autoimmune disorders, bleeding/clotting issues, stroke/neurovascular disease history, substance abuse problems including alcoholism and smoking history.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive human insulin (160 IU) administered as a bolus using an intra-nasal device
Follow-up
Participants are monitored for changes in muscle sympathetic nerve activity and cerebral blood flow
Treatment Details
Interventions
- Carbon dioxide breathing
- Human insulin
- Neurovascular Coupling
Human insulin is already approved in European Union, United States, Canada for the following indications:
- Type 1 diabetes
- Type 2 diabetes
- Gestational diabetes
- Diabetic ketoacidosis
- Hyperosmolar hyperglycemic states
- Type 1 diabetes
- Type 2 diabetes
- Gestational diabetes
- Diabetic ketoacidosis
- Hyperosmolar hyperglycemic states
- Type 1 diabetes
- Type 2 diabetes
- Gestational diabetes
- Diabetic ketoacidosis
- Hyperosmolar hyperglycemic states
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Missouri-Columbia
Lead Sponsor