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Completed

NCT Number: NCT04292535

Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

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

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Key information

Conditions

Insulin Behavior Exercise Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Kinesiology

East Lansing, Michigan, 48824, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Placebo into the intranasal mucosa

Drug

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

Other names: Saline

20 IU NovoLog Insulin aspart into the intranasal mucosa

Drug

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

Other names: NovoLog Insulin aspart

40 IU NovoLog Insulin aspart into the intranasal mucosa

Drug

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

Other names: NovoLog Insulin aspart

60 IU NovoLog Insulin aspart into the intranasal mucosa

Drug

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

Other names: NovoLog Insulin aspart

80 IU NovoLog Insulin aspart into the intranasal mucosa

Drug

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

Other names: NovoLog Insulin aspart

100 IU NovoLog Insulin aspart into the intranasal mucosa

Drug

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

Other names: NovoLog Insulin aspart

120 IU NovoLog Insulin aspart into the intranasal mucosa

Drug

6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Other names: NovoLog Insulin aspart

Primary outcomes

  1. Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol

    Time frame: During the 20 minute exercise/control period and the cognitive assessments.

    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.

  2. Number of Participants With Manifestation of Any Symptom Following the Protocol

    Time frame: 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)

    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.

  3. Effect Size for Change in Behavioral Index of Inhibitory Control - RT

    Time frame: Prior to intranasal insulin administration relative to 30 minutes following

    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.

  4. Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy

    Time frame: Prior to intranasal insulin administration relative to 30 minutes following

    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.

  5. Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task

    Time frame: Prior to intranasal insulin administration relative to 30 minutes following

    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.

  6. Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task

    Time frame: Prior to intranasal insulin administration relative to 30 minutes following

    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.

  7. Effect Size of Change in Behavioral Index of Sustained Attention - RT

    Time frame: Prior to intranasal insulin administration relative to 30 minutes following

    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.

  8. Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy

    Time frame: Prior to intranasal insulin administration relative to 30 minutes following

    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.

  9. Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task

    Time frame: Prior to intranasal insulin administration relative to 30 minutes following

    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.

  10. Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task

    Time frame: Prior to intranasal insulin administration relative to 30 minutes following

    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.

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2020
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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