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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03DK089090-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Use of human unacylated ghrelin (UAG, also called des-octanoyl ghrelin) to study physiology in healthy subjects. The proposed research is an investigator-initiated study funded by the National Institutes of Health designed to examine the effect of physiologic levels of UAG on the regulation of glucose homeostasis as well as beta cell function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| decaylated ghrelin | Experimental | UAG (4.0 µg/kg/hr) |
|
| acyl ghrelin | Experimental | AG (1.0 µg/kg/hr) |
|
| combined acyl and desacyl ghrelin | Experimental | the combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr) |
|
| saline | Placebo Comparator | saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| unacylated ghrelin | Drug | IV, UAG (4.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours) |
|
| Measure | Description | Time Frame |
|---|---|---|
| acute insulin release (AIRg) | The primary outcome measure will be AIRg. This is calculated as the incremental insulin release,following IV glucose administration. (For the first ten minutes of the study visit.) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | 1. Insulin sensitivity is quantified as the insulin sensitivity index (SI) using Bergman's minimal model of glucose kinetics from the glucose and insulin results obtained from a FSIGT. | one year |
| Disposition index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| C000710987 | acyl-ghrelin |
| C422650 | ghrelin, des-n-octanoyl |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| acyl ghrelin | Drug | IV, AG (1.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours) |
|
| combined acyl and desacyl ghrelin | Drug | IV, the combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr), one time, for the duration of the study visit (approximately 5 hours) |
|
| saline | Drug | IV, saline, one time, for the duration of the study visit(approximately 5 hours) |
|
2. The disposition index (DI) is a measure of β-cell function. It accounts for the modulating effect of insulin sensitivity on β-cell responses. It is calculated as the product of the SI and AIRg
| one year |
| glucose tolerance | 3. Glucose tolerance is measured by glucose disappearance constant. This is calculated as the slope of the natural log of glucose during the study visit, during a set time frame. | one year |
| D017670 |
| Sodium Compounds |