Placebo Controlled Phase II Clinical Trial: Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol
研究概览
简要总结
To determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind, placebo controlled trial
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be over the age of 18..
- •Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.
排除标准
- •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).
研究组 & 干预措施
Passive Control
20 minute sedentary control period during which participants watched an emotionally neutral video.
干预措施: Placebo into the intranasal mucosa (Drug)
Passive Control
20 minute sedentary control period during which participants watched an emotionally neutral video.
干预措施: 20 IU NovoLog Insulin aspart into the intranasal mucosa (Drug)
Passive Control
20 minute sedentary control period during which participants watched an emotionally neutral video.
干预措施: 40 IU NovoLog Insulin aspart into the intranasal mucosa (Drug)
Passive Control
20 minute sedentary control period during which participants watched an emotionally neutral video.
干预措施: 60 IU NovoLog Insulin aspart into the intranasal mucosa (Drug)
Passive Control
20 minute sedentary control period during which participants watched an emotionally neutral video.
干预措施: 80 IU NovoLog Insulin aspart into the intranasal mucosa (Drug)
Passive Control
20 minute sedentary control period during which participants watched an emotionally neutral video.
干预措施: 100 IU NovoLog Insulin aspart into the intranasal mucosa (Drug)
Passive Control
20 minute sedentary control period during which participants watched an emotionally neutral video.
干预措施: 120 IU NovoLog Insulin aspart into the intranasal mucosa (Drug)
Acute Exercise
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.
干预措施: Placebo into the intranasal mucosa (Drug)
Acute Exercise
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.
干预措施: 20 IU NovoLog Insulin aspart into the intranasal mucosa (Drug)
Acute Exercise
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.
干预措施: 40 IU NovoLog Insulin aspart into the intranasal mucosa (Drug)
Acute Exercise
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.
干预措施: 60 IU NovoLog Insulin aspart into the intranasal mucosa (Drug)
Acute Exercise
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.
干预措施: 80 IU NovoLog Insulin aspart into the intranasal mucosa (Drug)
Acute Exercise
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.
干预措施: 100 IU NovoLog Insulin aspart into the intranasal mucosa (Drug)
Acute Exercise
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.
干预措施: 120 IU NovoLog Insulin aspart into the intranasal mucosa (Drug)
结局指标
主要结局
Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol
时间窗: 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.
Number of Participants With Manifestation of Any Symptom Following the Protocol
时间窗: 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.
Effect Size for Change in Behavioral Index of Inhibitory Control - RT
时间窗: 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.
Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy
时间窗: 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.
Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task
时间窗: 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.
Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task
时间窗: 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.
Effect Size of Change in Behavioral Index of Sustained Attention - RT
时间窗: 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.
Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy
时间窗: 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.
Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task
时间窗: 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.
Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task
时间窗: 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.
次要结局
未报告次要终点
研究者
Matthew B. Pontifex, Ph.D.
Associate Professor
Michigan State University