Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

116

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jun 2018

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

June 15, 2018

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2020

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

June 21, 2021

Completed

Last Updated

June 21, 2021

Status Verified

May 1, 2021

Enrollment Period

1.7 years

First QC Date

February 28, 2020

Results QC Date

March 19, 2021

Last Update Submit

May 27, 2021

Conditions

Insulin Exercise

Keywords

Intranasal InsulinCognitionExercisePhysical Activity

Outcome Measures

Primary Outcomes (10)

Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol
The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. Burning/tingling of the nose and watering/tearing of the eyes during the nasal spray were the most cited symptoms.
During the 20 minute exercise/control period and the cognitive assessments.
Number of Participants With Manifestation of Any Symptom Following the Protocol
The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. The most cited symptom was having a runny nose.
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)
Effect Size for Change in Behavioral Index of Inhibitory Control - RT
The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a flanker test of inhibitory control. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Prior to intranasal insulin administration relative to 30 minutes following
Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy
The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a flanker test of inhibitory control. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Prior to intranasal insulin administration relative to 30 minutes following
Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Prior to intranasal insulin administration relative to 30 minutes following
Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Prior to intranasal insulin administration relative to 30 minutes following
Effect Size of Change in Behavioral Index of Sustained Attention - RT
The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a Rapid Visual Information Processing test of sustained attention. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Prior to intranasal insulin administration relative to 30 minutes following
Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy
The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a Rapid Visual Information Processing test of sustained attention. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Prior to intranasal insulin administration relative to 30 minutes following
Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Prior to intranasal insulin administration relative to 30 minutes following
Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Prior to intranasal insulin administration relative to 30 minutes following

Study Arms (2)

Passive Control

ACTIVE COMPARATOR

20 minute sedentary control period during which participants watched an emotionally neutral video.

Drug: Placebo into the intranasal mucosaDrug: 20 IU NovoLog Insulin aspart into the intranasal mucosaDrug: 40 IU NovoLog Insulin aspart into the intranasal mucosaDrug: 60 IU NovoLog Insulin aspart into the intranasal mucosaDrug: 80 IU NovoLog Insulin aspart into the intranasal mucosaDrug: 100 IU NovoLog Insulin aspart into the intranasal mucosaDrug: 120 IU NovoLog Insulin aspart into the intranasal mucosa

Acute Exercise

EXPERIMENTAL

20 minute physical activity period during which participants exercised on a treadmill at an intensity corresponding to 60-65% of maximum heart rate while watching an emotionally neutral video.

Interventions

Placebo into the intranasal mucosaDRUG

6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer

Also known as: Saline

Acute ExercisePassive Control

20 IU NovoLog Insulin aspart into the intranasal mucosaDRUG

5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer