Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

Exercise Clinical Trial

Official title:

Placebo Controlled Phase II Clinical Trial: Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292535
• Other study ID #: STUDY00000804
• Status: Completed
• Phase: Phase 2
• Start date: June 15, 2018
• Est. completion date: February 20, 2020

Study information

• Verified date: May 2021
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Exercise
• Insulin

Intervention

Drug:
• Placebo into the intranasal mucosa
6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
• 20 IU NovoLog Insulin aspart into the intranasal mucosa
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
• 40 IU NovoLog Insulin aspart into the intranasal mucosa
4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
• 60 IU NovoLog Insulin aspart into the intranasal mucosa
3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
• 80 IU NovoLog Insulin aspart into the intranasal mucosa
2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
• 100 IU NovoLog Insulin aspart into the intranasal mucosa
1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
• 120 IU NovoLog Insulin aspart into the intranasal mucosa
6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Locations

Country	Name	City	State
United States	Department of Kinesiology	East Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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