Clinical trial NCT04292535: Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
Official title: Placebo Controlled Phase II Clinical Trial: Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insulin
Exercise
Keywords: Intranasal Insulin
Cognition
Exercise
Physical Activity
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random allocation to a dose of intranasal insulin (0, 20, 40, 60, 80, 100, 120) Within each dose, random allocation to exercise or control activity.
Primary purpose: TREATMENT

Brief summary: To determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa.

Detailed description: Using a randomized placebo controlled double-blind pre-posttest design, participants will be randomly assigned to receive a dose of either 0, 20, 40, 60, 80, 100, or 120 IU of NovoLog insulin aspart prior to being randomized into participating in a 20 minute session of either moderate-intensity aerobic exercise or a passive control condition. The efficacy of the intranasal insulin for inducing alterations in cognition will be assessed using both behavioral and neuroelectric measures. The safety of the protocol will be assessed using a symptom questionnaire assessing common symptoms of altered blood glucose and common side effects of intranasal insulin.

Eligibility criteria: Inclusion Criteria:

1. Participants must be over the age of 18..
2. Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.

Exclusion Criteria:

1. Lack of consent.
2. Presence of any major neurological health issues, brain trauma, or concussion with loss of consciousness assessed through a health history and demographics questionnaire.
3. Type I or Type II Diabetes
4. Self-reported pregnancy
5. Currently has any type of inflammation or blockage of the nasal passageways (i.e. allergies or a cold affecting the sinuses).

Primary outcomes:
measure: Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol
timeFrame: During the 20 minute exercise/control period and the cognitive assessments.
measure: Number of Participants With Manifestation of Any Symptom Following the Protocol
timeFrame: Approximately 1 hour following the dose of intranasal insulin (~32 minutes following the end of the passive control/exercise condition; immediately following the completion of the post-test cognitive assessments)
measure: Effect Size for Change in Behavioral Index of Inhibitory Control - RT
timeFrame: Prior to intranasal insulin administration relative to 30 minutes following
measure: Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy
timeFrame: Prior to intranasal insulin administration relative to 30 minutes following
measure: Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task
timeFrame: Prior to intranasal insulin administration relative to 30 minutes following
measure: Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task
timeFrame: Prior to intranasal insulin administration relative to 30 minutes following
measure: Effect Size of Change in Behavioral Index of Sustained Attention - RT
timeFrame: Prior to intranasal insulin administration relative to 30 minutes following
measure: Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy
timeFrame: Prior to intranasal insulin administration relative to 30 minutes following
measure: Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task
timeFrame: Prior to intranasal insulin administration relative to 30 minutes following
measure: Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task
timeFrame: Prior to intranasal insulin administration relative to 30 minutes following
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Department of Kinesiology
state: Michigan
Study officials:
affiliation: Michigan State University
name: Matthew B Pontifex, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gwizdala KL, Ferguson DP, Kovan J, Novak V, Pontifex MB. Placebo controlled phase II clinical trial: Safety and efficacy of combining intranasal insulin & acute exercise. Metab Brain Dis. 2021 Aug;36(6):1289-1303. doi: 10.1007/s11011-021-00727-2. Epub 2021 Apr 15.