| Trial ID: | L2327 |
| Source ID: | NCT01206322
|
| Associated Drug: |
Intranasal Insulin
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| Title: |
Enhancement of Cerebral Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01206322/results
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| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Intranasal insulin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Cognitive Outcome: Brief Visuospatial Spatial Memory Test -Total Recall (Unit T Score), To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups. Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score). Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg). Each participant received a single dose of intranasal insulin (INI) or placebo on day 2 and a single dose dose of insulin or placebo on day 3 in a random order. Acute effects on baseline perfusion, regional vasoreactivity and cognition were determined within 2 hours after administration of insulin or placebo., Acute changes within 2 hours|Perfusion Outcome: Right Insular Cortex Perfusion (ml/100g/Min/mmHg), To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups. Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score). Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg)., Acute changes within 2 hours |
|
| Sponsor/Collaborators: |
Sponsor: Beth Israel Deaconess Medical Center | Collaborators: Boston University|Joslin Diabetes Center|Peking University|University of Washington|University of Arkansas|VA Boston Healthcare System|University of Massachusetts, Worcester|Wake Forest University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
|
| Start Date: |
2010-05
|
| Completion Date: |
2013-04
|
| Results First Posted: |
2014-10-28
|
| Last Update Posted: |
2019-06-26
|
| Locations: |
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01206322
|
