Influence of Central Nervous Insulin Action on Insulin Sensitivity of Peripheral Organs in Lean Versus Overweight Humans
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|ClinicalTrials.gov Identifier: NCT02468999|
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : January 8, 2016
Research in animals and first experiments in humans indicate that insulin action in the brain regulates peripheral insulin sensitivity. One major organ might be the liver. Previous studies in humans showed that the human brain is an insulin sensitive organ in lean but not in overweight/obese persons. Therefore, this study will include lean versus overweight/obese persons.
In this study, insulin action will be introduced by intranasal insulin administration in lean and overweight humans. As a control, placebo spray will be administered. To mimick the known spill over of small amounts of intranasal insulin into circulation, a small bolus of insulin will be administered over 15 minutes following placebo spray application.
Peripheral insulin sensitivity will be assessed by hyperinsulinemic-euglycemic glucose clamp and glucose uptake and endogenous glucose production will be assessed by tracer dilution technique. Autonomous nervous system activity will be addressed by heart rate variability. Involved brain areas will be addressed by fMRI before and after nasal insulin application.
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance||Drug: human insulin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: insulin nasal spray
160 Units of human insulin as nasal spray
Drug: human insulin
Placebo Comparator: placebo nasal spray
Nasal spray containing placebo solution
Drug: human insulin
- Change in glucose infusion rate during hyperinsulinemic euglycemic glucose clamp from before to after nasal spray application in lean persons [ Time Frame: Change from 70-90 min (before spray) to 170-210 min and to 280-300 min ]
- Change in endogenous glucose production from before to after nasal spray application in lean persons [ Time Frame: Change from 70-90 min (before spray) to 170-210 min and to 280-300 min ]Will be assessed by tracer dilution technique.
- Differences in insulin response between lean and overweight persons [ Time Frame: up to 210 minutes post nasal spray administration ]Will be assessed as plasma insulin and C-peptide concentrations.
- Autonomous nervous system activity [ Time Frame: baseline, 70-90 min, 170-210 min and 280-300 min ]Will be assessed by analysis of heart rate variability.
- Regional brain insulin sensitivity [ Time Frame: 30 min ]Will be assessed on an additional study day by fMRI before and after intranasal insulin administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468999
|University of Tuebingen, Department of Internal Medicine IV|
|Tübingen, Germany, 72076|
|Principal Investigator:||Andreas Fritsche, Prof. Dr.||University Hospital Tuebingen|