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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-SC220220 | Other Identifier | Department of Defense Congressionally Directed Medical Research Program |
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| Name | Class |
|---|---|
| Uniformed Services University of the Health Sciences | FED |
| Congressionally Directed Medical Research Programs | FED |
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The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, is safe when administered as a nasal spray (intranasally) to people who have experienced a spinal cord injury. While insulin nasal spray has been shown to be safe in many patient populations, it has not yet been studied in people with spinal cord injury. This study would be the first step to developing insulin nasal spray as a treatment for spinal cord injury in the future.
This study is recruiting up to 12 individuals who have experienced a spinal cord injury at least 4 months ago to administer either 76 IU insulin nasal spray or a placebo (inactive nasal spray) at home every day for up to 24 days. Participants will be asked questions about their health and symptoms related their spinal cord injury, and will have their blood collected throughout the study. Participants who are unable to administer the medication independently must have a study partner in order to participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Insulin | Experimental | Regular Insulin (Novolin-R) 76 international units per day administered as 38 IU in one nostril twice daily (alternating nostrils) for 21+/-3 days |
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| Placebo | Placebo Comparator | 0.9% sodium chloride in one nostril twice daily (alternating nostrils) for 21+/- days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular Insulin | Drug | Administered Intranasally at 76 IU |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by number of serious adverse events (SAE) and adverse events (AE) | Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment. AEs counts will include total count and will be stratified by severity. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment adherence as assessed by participant Daily Drug Diaries | Number of doses successfully administered as reported by participants in their daily drug diaries | 3 weeks |
| Feasibility of virtual training as assessed by the Virtual Training Compliance Checklist |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meghan E O'Brien, MPH | Contact | 651-495-6363 | Meghan.E.Obrien@HealthPartners.com | |
| Bethany K Crouse, PhD | Contact | Bethany.K.Crouse@HealthPartners.com |
| Name | Affiliation | Role |
|---|---|---|
| Leah R Hanson, PhD | HealthPartners Institute | Principal Investigator |
| Kimberly Byrnes, PhD | Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Neuroscience Center | Recruiting | Saint Paul | Minnesota | 55130 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Participants will be randomized 1:1 into one of 2 groups: 76 IU insulin, or saline (placebo) control
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| 0.9 % Normal Saline | Other | Placebo Control |
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Average score on virtual training compliance checklist, both arms combined |
| Baseline Visit |
| Acceptability of virtual training as assessed by the Virtual Training and Feasibility and Acceptability Survey | Total score on the Virtual Training Feasibility and Acceptability Survey, both arms combined | Baseline |
| Feasibility of blood spot collection procedure as measured by a Blood Spot Procedure Compliance Checklist | Participants will be trained to perform a blood spot collection procedure independently. Feasibility will be measured by the average score on blood spot procedure compliance checklist, both arms combined | Screening Visit |
| Acceptability of Blood Spot Procedure, as measured by a Blood Spot Procedure Post-Training Acceptability Survey | Acceptability of performing blood spot procedure independently will be measured by the average score on a blood spot procedure post-training acceptability survey, both arms combined | Screening Visit |
| D014947 | Wounds and Injuries |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |