Trial · NCT04292535
Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
NCT04292535, Phase 2, Completed, Michigan State University; results first posted 2021-06-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise. Trials, record NCT04292535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04292535
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
- NCT number
- NCT04292535
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 116 participants, actual
- Lead sponsor
- Michigan State University
- Conditions
- Insulin, Exercise
- Interventions
Placebo into the intranasal mucosa, 20 IU NovoLog Insulin aspart into the intranasal mucosa, 40 IU NovoLog Insulin aspart into the intranasal mucosa, 60 IU NovoLog Insulin aspart into the intranasal mucosa, 80 IU NovoLog Insulin aspart into the intranasal mucosa, 100 IU NovoLog Insulin aspart into the intranasal mucosa, 120 IU NovoLog Insulin aspart into the intranasal mucosa
- First posted
- 2020-03-03
- Last updated
- 2021-06-21
- Results first posted
- 2021-06-21
- Limitations and caveats
As the present investigation was a Phase II Clinical Trial, the research design was not sufficiently powered for hypothesis testing. Given the potential risk of combining exercise with intranasal insulin the present investigation utilized a sample of healthy, non-diabetic, fasted college-aged adults to limit the potential for a serious adverse event.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 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. |
| Primary | Number of Participants With Manifestation of Any Symptom Following the Protocol | 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. |
| Primary | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | 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. |
| Primary | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | 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. |
| Primary | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | 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. |
| Primary | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | 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. |
| Primary | Effect Size of Change in Behavioral Index of Sustained Attention - RT | 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. |
| Primary | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 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. |
| Primary | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | 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. |
| Primary | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | During the 20 minute exercise/control period and the cognitive assessments. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Manifestation of Any Symptom Following the Protocol | 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) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | Prior to intranasal insulin administration relative to 30 minutes following | cohens d | MEAN | |
| PRIMARY | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | Prior to intranasal insulin administration relative to 30 minutes following | cohens d | MEAN | |
| PRIMARY | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | Prior to intranasal insulin administration relative to 30 minutes following | cohens d | MEAN | |
| PRIMARY | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | Prior to intranasal insulin administration relative to 30 minutes following | cohens d | MEAN | |
| PRIMARY | Effect Size of Change in Behavioral Index of Sustained Attention - RT | Prior to intranasal insulin administration relative to 30 minutes following | cohens d | MEAN | |
| PRIMARY | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | Prior to intranasal insulin administration relative to 30 minutes following | cohens d | MEAN | |
| PRIMARY | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | Prior to intranasal insulin administration relative to 30 minutes following | cohens d | MEAN | |
| PRIMARY | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | Prior to intranasal insulin administration relative to 30 minutes following | cohens d | MEAN |
Source ClinicalTrials.gov
Results by group140
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | Passive Control - Placebo | 4 | Participants | ||
| Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | Passive Control - 20 IU | 6 | Participants | ||
| Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | Passive Control - 40 IU | 6 | Participants | ||
| Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | Passive Control - 60 IU | 4 | Participants | ||
| Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | Passive Control - 80 IU | 5 | Participants | ||
| Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | Passive Control - 100 IU | 9 | Participants | ||
| Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | Passive Control - 120 IU | 5 | Participants | ||
| Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | Acute Exercise - Placebo | 2 | Participants | ||
| Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | Acute Exercise - 20 IU | 4 | Participants | ||
| Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | Acute Exercise - 40 IU | 3 | Participants |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Passive Control - Placebo | 8 | |
| Overall Study | STARTED | Passive Control - 20 IU | 8 | |
| Overall Study | STARTED | Passive Control - 40 IU | 9 | |
| Overall Study | STARTED | Passive Control - 60 IU | 8 | |
| Overall Study | STARTED | Passive Control - 80 IU | 8 | |
| Overall Study | STARTED | Passive Control - 100 IU | 9 | |
| Overall Study | STARTED | Passive Control - 120 IU | 8 | |
| Overall Study | STARTED | Acute Exercise - Placebo | 10 | |
| Overall Study | STARTED | Acute Exercise - 20 IU | 8 | |
| Overall Study | STARTED | Acute Exercise - 40 IU | 8 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypoglycemic event | Metabolism and nutrition disorders | Passive Control - Placebo | 0 | 8 | 0 |
| other | Hypoglycemic event | Metabolism and nutrition disorders | Passive Control - 20 IU | 0 | 8 | 0 |
| other | Hypoglycemic event | Metabolism and nutrition disorders | Passive Control - 40 IU | 0 | 9 | 0 |
| other | Hypoglycemic event | Metabolism and nutrition disorders | Passive Control - 60 IU | 0 | 8 | 0 |
| other | Hypoglycemic event | Metabolism and nutrition disorders | Passive Control - 80 IU | 0 | 8 | 0 |
| other | Hypoglycemic event | Metabolism and nutrition disorders | Passive Control - 100 IU | 0 | 9 | 0 |
| other | Hypoglycemic event | Metabolism and nutrition disorders | Passive Control - 120 IU | 0 | 8 | 0 |
| other | Hypoglycemic event | Metabolism and nutrition disorders | Acute Exercise - Placebo | 1 | 10 | 1 |
| other | Hypoglycemic event | Metabolism and nutrition disorders | Acute Exercise - 20 IU | 0 | 8 | 0 |
| other | Hypoglycemic event | Metabolism and nutrition disorders | Acute Exercise - 40 IU | 0 | 8 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Passive Control - Placebo | 0 | 8 |
| Total, all-cause mortality | Passive Control - 20 IU | 0 | 8 |
| Total, all-cause mortality | Passive Control - 40 IU | 0 | 9 |
| Total, all-cause mortality | Passive Control - 60 IU | 0 | 8 |
| Total, all-cause mortality | Passive Control - 80 IU | 0 | 8 |
| Total, all-cause mortality | Passive Control - 100 IU | 0 | 9 |
| Total, all-cause mortality | Passive Control - 120 IU | 0 | 8 |
| Total, all-cause mortality | Acute Exercise - Placebo | 0 | 10 |
| Total, all-cause mortality | Acute Exercise - 20 IU | 0 | 8 |
| Total, all-cause mortality | Acute Exercise - 40 IU | 0 | 8 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33856613 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Eriksen Flanker Task | Primary outcome | ConductCognition |
| Rapid Visual Information Processing | Primary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04292535
GET https://conductscience.org/api/trials/v1/NCT04292535/results?page=2