Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity
This study has been completed.
University Hospital Tuebingen
Information provided by (Responsible Party):
andreas fritsche, University Hospital Tuebingen
First received: April 28, 2013
Last updated: December 20, 2013
Last verified: December 2013
The researchers will investigate if brain insulin action influences peripheral insulin sensitivity in healthy humans.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
|Official Title:||Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by University Hospital Tuebingen:
Primary Outcome Measures:
- Insulin sensitivity as measured by clamp [ Time Frame: 45 minutes to 120 minutes post nasal spray ] [ Designated as safety issue: No ]We will measure insulin sensitivity by hyperinsulinemic euglycemic clamp before and after nasal spray application. We will compare the post-spray insulin sensitivity between the two condition (insulin nasal spray vs placebo nasal spray). Furthermore, we will compare insulin sensitivity before and after nasal insulin application.
Secondary Outcome Measures:
- Autonomous nervous system activity [ Time Frame: 45 to 120 minutes post spray ] [ Designated as safety issue: No ]Activity of the autonomous nervous system will be estimated by heart rate variability in ECG. We will compare the post-spray autonomous nervous system activity between the two condition (insulin nasal spray vs placebo nasal spray). Furthermore, we will compare autonomous nervous system activity before and after nasal insulin application.
|Study Start Date:||April 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: insulin nasal spray
160 Units of human insulin as nasal spray
|Drug: human insulin as nasal spray|
Placebo Comparator: Placebo nasal spray
Nasalspray containing placebo solution
Contacts and Locations