65 Participants Needed

Intranasal Insulin for Insulin Resistance

JL
JK
Overseen ByJacqueline K Limberg, Ph.D.
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Missouri-Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

JK

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

Non-pregnant/non-breastfeeding
Your body mass index (BMI) is between 18 and 30.
You have a body mass index (BMI) higher than 18 kg/m2.
See 5 more

Exclusion Criteria

I have a history of diabetes.
I am not on medications that affect my metabolism, breathing, heart, or involuntary functions.
I have a history of bleeding or clotting disorders.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive human insulin (160 IU) administered as a bolus using an intra-nasal device

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in muscle sympathetic nerve activity and cerebral blood flow

15 minutes

Treatment Details

Interventions

  • Carbon dioxide breathing
  • Human insulin
  • Neurovascular Coupling
Trial Overview The study investigates the effects of increased brain insulin on sympathetic nervous system activity and blood flow in the body and brain. Participants will undergo carbon dioxide breathing tests to assess neurovascular coupling after receiving human insulin intranasally.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Time Control (Doppler)Experimental Treatment2 Interventions
Time control only
Group II: Insulin (MRI)Experimental Treatment2 Interventions
Human insulin (160 IU) will be administered as a bolus using an intra-nasal device.
Group III: Insulin (Doppler)Experimental Treatment3 Interventions
Human insulin (160 IU) will be administered as a bolus using an intra-nasal device.

Human insulin is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Humulin R for:
  • Type 1 diabetes
  • Type 2 diabetes
  • Gestational diabetes
  • Diabetic ketoacidosis
  • Hyperosmolar hyperglycemic states
🇺🇸
Approved in United States as Humulin R for:
  • Type 1 diabetes
  • Type 2 diabetes
  • Gestational diabetes
  • Diabetic ketoacidosis
  • Hyperosmolar hyperglycemic states
🇨🇦
Approved in Canada as Humulin R for:
  • 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

Trials
387
Recruited
629,000+

Findings from Research

Mixing human soluble insulin with newly developed crystalline zinc-suspension formulations significantly reduced the rise in free insulin levels and delayed the onset of action of the short-acting insulins in both normal and diabetic subjects.
This loss of solubility when mixing these insulins may limit their effectiveness in controlling blood sugar levels after meals, suggesting that careful consideration is needed when preparing insulin for injection.
The effect of mixing human soluble and human crystalline zinc-suspension insulin: plasma insulin and blood glucose profiles after subcutaneous injection.Francis, AJ., Hanning, I., Alberti, KG.[2019]
In a study of 10 client-owned dogs with well-regulated diabetes mellitus, Humulin N effectively suppressed blood glucose levels by an average of 49.9%, indicating its efficacy as a treatment.
The duration of insulin action varied between 4 to 10 hours, and some dogs experienced an initial rise in blood glucose after insulin administration, highlighting the need for careful monitoring of postprandial glucose levels.
An investigation of the action of Neutral Protamine Hagedorn human analogue insulin in dogs with naturally occurring diabetes mellitus.Palm, CA., Boston, RC., Refsal, KR., et al.[2016]
In a clinical trial involving 211 diabetic patients over 12 weeks, both Yousilin R and Novolin R significantly reduced glycosylated hemoglobin A1c (HbA1c) levels, indicating effective blood sugar control, with no significant difference between the two treatments.
The safety profiles of Yousilin R and Novolin R were comparable, with similar rates of hypoglycemic events and other adverse effects, suggesting that Yousilin R is a safe alternative to Novolin R for diabetes management.
[The efficacy and safety of recombinant human insulin injection in the treatment of diabetic patients:a multicenter, randomized, controlled and open-labeled clinical trial].Che, TT., Wang, X., Liu, YY., et al.[2014]

References

The effect of mixing human soluble and human crystalline zinc-suspension insulin: plasma insulin and blood glucose profiles after subcutaneous injection. [2019]
An investigation of the action of Neutral Protamine Hagedorn human analogue insulin in dogs with naturally occurring diabetes mellitus. [2016]
[The efficacy and safety of recombinant human insulin injection in the treatment of diabetic patients:a multicenter, randomized, controlled and open-labeled clinical trial]. [2014]
Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus. [2023]
Subcutaneous use of regular human insulin (Novo): pharmacokinetics and continuous insulin infusion therapy. [2011]
A randomized pharmacokinetic and pharmacodynamic trial of two regular human insulins demonstrates bioequivalence in type 1 diabetes and availability of biosimilar insulin may improve access to this medication. [2023]
The U.S. "new patient" and "transfer" studies. [2019]
Intranasally administered insulin intended for prevention of type 1 diabetes--a safety study in healthy adults. [2011]
Outcomes and clinical implications of intranasal insulin on cognition in humans: A systematic review and meta-analysis. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Enhanced absorption of Nasulin™, an ultrarapid-acting intranasal insulin formulation, using single nostril administration in normal subjects. [2021]
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