Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at minute 15
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 45 years old.
Select...
I am between 18 and 45 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at minute 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at minute 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amount of cerebral blood flow
Secondary outcome measures
Amount of leg blood flow
Amount of muscle sympathetic nerve activity (MSNA)
Side effects data
From 2021 Phase 4 trial • 452 Patients • NCT0483436217%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Analog Insulin Arm
Human Insulin Arm
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
362 Previous Clinical Trials
628,049 Total Patients Enrolled
10 Trials studying Insulin Resistance
323 Patients Enrolled for Insulin Resistance
Jacqueline K Limberg, Ph.D.Principal InvestigatorUniversity of Missouri-Columbia
3 Previous Clinical Trials
89 Total Patients Enrolled
1 Trials studying Insulin Resistance
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have smoked in the past.You have a history of drinking too much alcohol or using drugs.You have had a disease where your own immune system attacks your body.Your body mass index (BMI) is between 18 and 30.I am between 18 and 45 years old.I have a history of liver, kidney, lung, heart, or brain disease.I have a history of cancer.I am between 18 and 45 years old.You have a body mass index (BMI) higher than 18 kg/m2.You do not use nicotine.You do not use nicotine.I have a history of high blood pressure.I am a healthy adult.I have a history of lung or breathing problems.I have had a stroke or a disease affecting my brain's blood vessels.I have a history of sleep apnea or other sleep disorders.I am a healthy adult.
Research Study Groups:
This trial has the following groups:- Group 1: Insulin (MRI)
- Group 2: Time Control (Doppler)
- Group 3: Insulin (Doppler)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation targeting adults above twenty years of age?
"According to the trial's conditions, only individuals aged 18-45 are eligible to partake in this research."
Answered by AI
Are there any open slots for participants in this clinical research?
"Affirmative. Clinicaltrials.gov provides evidence that this scientific experiment, which was inaugurated on December 1st 2021, is presently recruiting participants. A total of 27 individuals are needed from one site for the study to succeed."
Answered by AI
How many participants is this experiment aiming to enroll?
"Affirmative. Clinicaltrials.gov has evidence that this scientific test, which was initially posted on December 1st 2021, is currently recruiting participants. There is a need for 27 patients to be enrolled at one medical facility."
Answered by AI
Could you provide an overview of research conducted using Human insulin?
"Currently, 72 clinical trials are exploring the efficacy of Human insulin. Out of those studies, 13 have advanced to Phase 3 testing. Most of these initiatives are based in Sao Luis, MA but there is a total 248 sites running this research worldwide."
Answered by AI
Am I able to enroll in this experiment?
"The team is seeking 27 participants, ranging from young adulthood to middle age and exhibiting vasodilation. Additionally, these individuals must be healthy adult males or females; 18-45 years old; BMI between 18-30 kg/m2; not currently pregnant nor breastfeeding; and non-nicotine users."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
How old are they?
18 - 65
What site did they apply to?
University of Missouri
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger