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Hormone Therapy

Intranasal Insulin for Insulin Resistance

Phase < 1
Recruiting
Led By Jacqueline K Limberg, Ph.D.
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-45 years of age;
Aged 18-45 years
Must not have
History of diabetes
History of bleeding/clotting disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at minute 15
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether increasing brain insulin can help regulate blood flow and the nervous system.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from nasal administration of insulin, changes in blood pressure or heart rate due to CO2 breathing tests. There might also be temporary alterations in peripheral and cerebral vasodilation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.
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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of diabetes.
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I have a history of bleeding or clotting disorders.
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I have a history of cancer.
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I have a history of lung or breathing problems.
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I have had a stroke or a disease affecting my brain's blood vessels.
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I have a history of sleep apnea or other sleep disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at minute 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at minute 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amount of cerebral blood flow
Secondary study objectives
Amount of leg blood flow
Amount of muscle sympathetic nerve activity (MSNA)

Side effects data

From 2021 Phase 4 trial • 452 Patients • NCT04834362
17%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Analog Insulin Arm
Human Insulin Arm

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human insulin
2021
Completed Phase 4
~550

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
380 Previous Clinical Trials
628,697 Total Patients Enrolled
5 Trials studying Vasodilation
340 Patients Enrolled for Vasodilation
Jacqueline K Limberg, Ph.D.Principal InvestigatorUniversity of Missouri-Columbia
3 Previous Clinical Trials
89 Total Patients Enrolled
2 Trials studying Vasodilation
89 Patients Enrolled for Vasodilation

Media Library

Human insulin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05153395 — Phase < 1
Vasodilation Research Study Groups: Insulin (MRI), Time Control (Doppler), Insulin (Doppler)
Vasodilation Clinical Trial 2023: Human insulin Highlights & Side Effects. Trial Name: NCT05153395 — Phase < 1
Human insulin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05153395 — Phase < 1
~20 spots leftby Jun 2026
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