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Intranasal Insulin in Healthy Subjects (INI-CSF Trial)

Phase 1
Recruiting
Led By Leah R Hanson, PhD
Research Sponsored by HealthPartners Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-40 minutes post-intranasal administration
Awards & highlights

INI-CSF Trial Summary

This trial will study the ability of a nasal spray to deliver insulin to the brain & spinal cord in healthy adults.

Who is the study for?
This trial is for healthy adults aged 18-35 with a BMI of 18.5-24.9, who speak English and can consent to the study. Women must not be pregnant or breastfeeding, and participants should have no recent clinical trial involvement, insulin-dependent diabetes, contraindications to spinal taps, nasal/pharyngeal surgery history, severe deviated septum or significant health issues.Check my eligibility
What is being tested?
The study tests if insulin reaches the brain when given as a nasal spray in two doses (40 units 'low dose' or 80 units 'high dose') to healthy adults. It involves taking cerebrospinal fluid samples at different times after dosing to measure insulin levels and assess delivery effectiveness using the SipNose device.See study design
What are the potential side effects?
Potential side effects may include discomfort from the lumbar puncture procedure such as back pain or headache; risks associated with intranasal administration like nosebleeds or irritation; and systemic effects of insulin that could affect blood sugar levels.

INI-CSF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-40 minutes post-intranasal administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-40 minutes post-intranasal administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC (area under the curve) of insulin concentration - Cerebrospinal Fluid
Cmax of insulin concentration - Cerebrospinal Fluid
Insulin Concentration Over Time - Cerebrospinal Fluid
+1 more
Secondary outcome measures
AUC (area under the curve) of insulin concentration - Serum
Cmax of insulin concentration - Serum
Insulin Concentration Over Time - Serum
+1 more

INI-CSF Trial Design

2Treatment groups
Experimental Treatment
Group I: Low dose Intranasal InsulinExperimental Treatment1 Intervention
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
Group II: High dose Intranasal InsulinExperimental Treatment1 Intervention
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

HealthPartners InstituteLead Sponsor
186 Previous Clinical Trials
3,716,155 Total Patients Enrolled
Leah R Hanson, PhDPrincipal InvestigatorHealthPartners Neuroscience Research
3 Previous Clinical Trials
170 Total Patients Enrolled

Media Library

Low dose Intranasal Insulin Clinical Trial Eligibility Overview. Trial Name: NCT05866367 — Phase 1
Healthy Subjects Research Study Groups: Low dose Intranasal Insulin, High dose Intranasal Insulin
Healthy Subjects Clinical Trial 2023: Low dose Intranasal Insulin Highlights & Side Effects. Trial Name: NCT05866367 — Phase 1
Low dose Intranasal Insulin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05866367 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility to participate in this trial open at present?

"Eligible individuals must have no major health issues and be between 18-35 years of age. This trial is seeking 12 participants in total."

Answered by AI

Is this research project still in need of participants?

"According to records on clinicaltrials.gov, the enrolment period for this research project has ended and they are not currently accepting any applicants. This trial was first published on May 1st 2023 before being updated 17 days later. However, 830 other studies remain open to participants at present."

Answered by AI

Does this clinical trial permit patients younger than fifty to participate?

"This trial is tailored to patients between the ages of 18 and 35. Alternatively, there are 58 trials for those under 18 as well as 377 trials suitable for elderly individuals over 65 years old."

Answered by AI

Has the FDA greenlit Low dose Intranasal Insulin for use by physicians?

"The safety rating of Low Dose Intranasal Insulin is a 1, as there is little existing evidence to support its efficacy and only limited data on its potential risks."

Answered by AI

What purpose does this research endeavor seek to achieve?

"This clinical trial, which will assess insulin concentrations in the Cerebrospinal Fluid over a 0-40 minutes post-intranasal administration window, aims to calculate peak concentration (Cmax), time of peak concentration (Tmax) and area under the curve (AUC). Serum insulin levels at 5 separate points throughout this timeframe - pre-dose as well as 10, 20, 30 and 40 minutes after - are measured against mean values with standard error reported. Cmax, Tmax and AUC measurements for serum insulin concentrations will also be provided."

Answered by AI

Who else is applying?

What site did they apply to?
HealthPartners Neuroscience Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Looking for healthy volunteers so I'm there to help. Looking to volunteer and contribute to clinical research.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose
2023. "Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05866367.
~0 spots leftby May 2024
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