Exercise Clinical Trial
Official title:
Placebo Controlled Phase II Clinical Trial: Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
Verified date | May 2021 |
Source | Michigan State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa.
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). |
Country | Name | City | State |
---|---|---|---|
United States | Department of Kinesiology | East Lansing | Michigan |
Lead Sponsor | Collaborator |
---|---|
Michigan State University |
United States,
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 |
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