Intranasal Insulin for Insulin Resistance
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Missouri-Columbia
Must not be taking: Metabolic, cardiovascular drugs
Disqualifiers: Diabetes, Hypertension, Cancer, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
12367How 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.
158910Eligibility 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.
I am between 18 and 45 years old.
+7 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.
+9 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of MissouriColumbia, MO
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Who Is Running the Clinical Trial?
University of Missouri-ColumbiaLead Sponsor
References
The effect of mixing human soluble and human crystalline zinc-suspension insulin: plasma insulin and blood glucose profiles after subcutaneous injection. [2019]The effect of mixing human soluble insulin with two newly developed formulations of human crystalline zinc-suspension insulin was studied in two groups of 8 normal and 6 diabetic subjects. Mixing Human Actrapid with Human Ultratard and Humulin-S with Humulin-Zn, for 60 s before subcutaneous injection, significantly blunted the rise in free insulin levels (p less than 0.05) and the onset of action of the short-acting insulins (p less than 0.01). The loss of solubility that occurs on mixing these insulins, with the consequent loss of the rapid acting component, may diminish their therapeutic usefulness in the control of post-prandial blood glucose.
An investigation of the action of Neutral Protamine Hagedorn human analogue insulin in dogs with naturally occurring diabetes mellitus. [2016]Neutral Protamine Hagedorn human analogue insulin (Humulin N) is commonly used for treatment of canine diabetes mellitus (DM). However, blood glucose and serum insulin concentrations in Humulin N-treated dogs with naturally occurring DM have not been reported.
[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]A multicenter, randomized, controlled and open-labeled clinical trial was performed to compare the efficacy and safety of recombinant human insulin injection (Yousilin R) and Novolin R in diabetic patients.
Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus. [2023]To compare the effects of the neutral protamine Hagedorn (NPH) recombinant human insulin formulations Gansulin and Humulin N® on the glycemic control of patients with type 2 diabetes mellitus (T2DM).
Subcutaneous use of regular human insulin (Novo): pharmacokinetics and continuous insulin infusion therapy. [2011]The absorption kinetics of human insulin (Novo) were studied and compared with those of purified porcine insulin preparations in seven healthy men. The absorption of insulin after subcutaneous injection of human insulin (Actrapid, Novo) was significantly accelerated and its hypoglycemic effect significantly stronger when compared with porcine insulin (Actrapid). No differences in the absorption kinetics were observed using human insulin (Monotard, Novo) and porcine insulin (Monotard) preparations, respectively. A clinical trial was designed to determine whether the pharmacokinetic differences were relevant for the clinical use of regular human insulin. The efficacy of human and porcine insulin (Actrapid) was tested in a double-blind crossover protocol in 12 type I diabetic patients treated with continuous subcutaneous insulin infusion. Near-normoglycemia was achieved with both types of insulin. Diurnal blood glucose values and excursions, insulin requirements, the frequency of mild hypoglycemic episodes, and the carbohydrate content of the diet were essentially identical. Thus, the differences between the absorption of human insulin and porcine regular insulin from a subcutaneous depot as observed in the pharmacokinetic studies in normal man do not appear to be relevant in the clinical practice of the subcutaneous insulin replacement therapy in type I diabetes mellitus at near-normoglycemia.
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]To compare the pharmacokinetic (PK) and pharmacodynamic (PD) effects and safety of therapeutic dosages of a regular insulin (experimental drug) produced by Bioton S.A. (Warsaw, Poland) versus Humulin® R, a regular insulin (reference drug) produced by Eli Lilly (Indianapolis, Indiana).
The U.S. "new patient" and "transfer" studies. [2019]The large-scale clinical trials of human insulin (recombinant DNA) in the United States consisted of a "New Patient" study and a "Transfer" study. The "New Patient" study involved 101 patients (38% type I) who have never received insulin and who were treated with human insulin and followed for 6 mo using NPH insulin alone or in combination with Neutral Regular Insulin (NRI). Shortly after treatment, serum glucose and total glycohemoglobin concentration fell. No patients developed insulin lipoatrophy or insulin allergy. Two patients developed insulin hypertrophy; in one, it was transient. Intradermal tests to varying dilutions of human insulin did not change over 6 mo. In addition, there was no evidence of development of antibodies to Escherichia coli polypeptide. Two-hundred-and-forty-three patients, 91% of whom had type I diabetes, were transferred in a controlled double-blind study from mixed beef-pork or purified pork insulin (PPI) either to human insulin or back to their previous insulin treatment and followed for 3 mo. While insulin dosage did not change, there was a slight increase in fasting serum glucose and a statistically significant increase in fasting ketonuria. There was no change in the frequency of the complications of insulin treatment. These limited data are consistent with the conclusion that NPH human insulin is slightly shorter acting than its animal insulin counterparts. Overall, human insulin is a safe, effective insulin.
Intranasally administered insulin intended for prevention of type 1 diabetes--a safety study in healthy adults. [2011]Intranasally applied insulin is one of the antigen-specific therapies currently tested in clinical type 1 diabetes prevention trials, for example, in the Type 1 Diabetes Prediction and Prevention Study (DIPP). The possibility that the therapy may cause hypoglycaemia or local irritation and the poorly known immunological safety of mucosal application of the antigen in healthy subjects prompted this study.
Outcomes and clinical implications of intranasal insulin on cognition in humans: A systematic review and meta-analysis. [2023]Aberrant brain insulin signaling has been posited to lie at the crossroads of several metabolic and cognitive disorders. Intranasal insulin (INI) is a non-invasive approach that allows investigation and modulation of insulin signaling in the brain while limiting peripheral side effects.
Enhanced absorption of Nasulin™, an ultrarapid-acting intranasal insulin formulation, using single nostril administration in normal subjects. [2021]This pharmacokinetic (PK) study was designed to investigate the maximum intranasal insulin dose that could be achieved by repeated doses in a single nostril of a nasal spray of recombinant regular human insulin 1% in combination with cyclopentadecalactone (CPE-215) 2%, a compound that enhances absorption of molecules across mucous membranes (Nasulin™, CPEX Pharmaceuticals, Inc.).