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Obesity if known to be associated with brain insulin resistance in humans. This condition has not only implication for the brain but also for whole-body energy homeostasis. Research in rodents indicates that weight loss is able to improve insulin sensitivity of the brain. The current project will test this hypothesis in humans. Therefore, brain insulin sensitivity will be assessed by fMRI in combination with intranasal insulin administration, using an established protocol. Furthermore, effects of daily administration of insulin nasal spray (versus placebo) over 8 weeks will be assessed as secondary (exploratory) variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nasal insulin | Active Comparator | daily administration of 160 U of human insulin as nasal spray |
|
| placebo spray | Placebo Comparator | daily administration of placebo solution as nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasal insulin | Other |
| ||
| placebo spray |
| Measure | Description | Time Frame |
|---|---|---|
| brain insulin sensitivity | fMRI measurement will be performed before and after administration of 160 U of human insulin as nasal spray. Changes in regional activity will be quantified to assess regional brain insulin sensitivity. | 30 minutes after administration of nasal insulin |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body weight. | Participants will receive nasal insulin or placebo in a double-blind randomized fashion. Before and after 8 weeks body weight will be recorded. | 8 weeks |
| Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on glucose tolerance . |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Fritsche, MD | Contact | +49 7071 29 80687 | andreas.fritsche@med.uni-tuebingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Fritsche, MD | University of Tübingen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tuebingen, Department of Internal Medicine IV | Recruiting | Tübingen | 72076 | Germany |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants will receive nasal insulin or placebo in a double-blind randomized fashion. Before and after 8 weeks glucose tolerance will be assessed using a 75 g oral glucose tolerance test. |
| 8 weeks |
| Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body composition . | Participants will receive nasal insulin or placebo in a double-blind randomized fashion. Before and after 8 weeks body composition will be addressed by whole-body MRI and liver MRS. | 8 weeks |
| whole-body insulin sensitivity | Insulin sensitivity will be estimated from a frequent-sampling 75 g oral glucose tolerance test using the Matsuda formula. | 2 hours |
| Glucose tolerance | a 75 g oral glucose tolerance test will be performed. Glucose tolerance will be defined by the American Diabetes Association criteria. | 2 hours |
| Cognitive function | cognitive function will be addressed by neuropsychological testing. | 1 hours |