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Cerebral insulin resistance plays an important role in the development of obesity and diabetes mellitus type 2. The aim of this project is to examine the effect of human nasal insulin on the dopaminergic system. Therefore, characteristics of cerebral dopamine receptors before and after administration of nasal insulin vs. placebo shall be analyzed in a randomized way. Moreover, the investigators plan to examine the insulin action on cortical and subcortical activation in humans and the interaction of dopamine metabolism with [11C]-Raclopride-PET/MRI. By performing fMRI measurements, insulin sensitivity of the central nervous system can be investigated simultaneously. Recruiting is planed as a two-step process.First 12 normal-weight (BMI 20-25 kg/m²) men should be examined. If first results show a insulin-dependent effect on the availability of dopamine receptors in the human brain, recruitment of 12 overweight men will get started.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Intranasal placebo administration |
|
| Intranasal insulin | Active Comparator | Intranasal insulin administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal insulin | Other | intranasal administration of insulin (160 IU) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of nasal insulin vs. placebo on the insulin sensitivity of the human brain as well as effects on regional availability of dopamine receptors. | assessed by fMRI (insulin sensitivity of the brain measured as change in regional brain activity and Raclopride-PET/MRT (regional dopamine receptor availability). | 0-60 min |
| Measure | Description | Time Frame |
|---|---|---|
| Differences between normalweight and overweight subjects regarding insulin sensitivity and availability of dopamine receptors | assessed by fMRI and Raclopride-PET/MRT | 0 - 60 min |
| Effects of nasal insulin vs. placebo on changes in plasma insulin levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tuebingen, Department of Internal Medicine IV | Tübingen | 72076 | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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single-blinded, monocentric, prospective crossover study
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| Placebo |
| Other |
placebo intranasal administration |
|
assessed by blood sampling after application. |
| 0 - 60min |
| Effects of nasal insulin vs. placebo on changes in plasma glucose levels | assessed by blood sampling after application. | 0 - 60min |
| Effects of nasal insulin vs. placebo on changes in FFA levels | assessed by blood sampling after application. | 0 - 60min |
| Effects of nasal insulin vs. placebo on changes in prolactin levels as a proxy for the dopaminergic tonus | assessed by blood sampling after application. | 0 - 60min |
| Effects of nasal insulin vs. placebo on changes in autonomic nervous system | assessed by heart rate variability. | -30 - 60 min |
| D004700 | Endocrine System Diseases |