Phase 2 N=116 Randomized Double-blind Treatment

Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

Insulin · Exercise

Bottom Line

View on ClinicalTrials.gov: NCT04292535 ↗

Enrolled (actual)

116

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol — 4; 6; 6; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo into the intranasal mucosa (Drug); 20 IU NovoLog Insulin aspart into the intranasal mucosa (Drug); 40 IU NovoLog Insulin aspart into the intranasal mucosa (Drug); 60 IU NovoLog Insulin aspart into the intranasal mucosa (Drug); 80 IU NovoLog Insulin aspart into the intranasal mucosa (Drug); 100 IU NovoLog Insulin aspart into the intranasal mucosa (Drug); 120 IU NovoLog Insulin aspart into the intranasal mucosa (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Michigan State University
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol	4; 6; 6; 4; 5; 9	—
PRIMARY Number of Participants With Manifestation of Any Symptom Following the Protocol	1; 2; 0; 2; 1; 4	—
PRIMARY Effect Size for Change in Behavioral Index of Inhibitory Control - RT	-0.04; -0.29; -0.54; -0.10; -0.42; -0.25	—
PRIMARY Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy	-0.03; 0.16; -0.04; -0.19; -0.06; -0.14	—
PRIMARY Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task	0.07; -0.08; -0.01; 0.00; 0.00; -0.06	—
PRIMARY Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task	-0.22; -0.06; 0.16; 0.15; -0.42; 0.06	—
PRIMARY Effect Size of Change in Behavioral Index of Sustained Attention - RT	-0.18; -0.16; -0.15; -0.24; -0.20; -0.22	—
PRIMARY Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy	0.69; 0.81; 0.05; 0.87; 0.62; 0.71	—
PRIMARY Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task	-0.02; -0.09; 0.04; 0.23; 0.02; 0.16	—
PRIMARY Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task	0.08; -0.06; -0.08; -0.09; 0.26; 0.25	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04292535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.