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Futility
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The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp
Assignment: Each study subject will serve as their own control. The order of the visits will be randomized.
Delivery of Interventions:
Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
During the inpatient study, the subjects will
Undergo a 16-hour kisspeptin infusion Undergo a hyperglycemic clamp
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kisspeptin | Experimental | Intravenous administration of kisspeptin 112-121 x 16 hours |
|
| Placebo | Placebo Comparator | Intravenous administration of placebo x 16 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperglycemic Clamp | Diagnostic Test | Administration of a hyperglycemic clamp |
|
| Measure | Description | Time Frame |
|---|---|---|
| First Phase Insulin Secretion | Average Change in First Phase Insulin Secretion Between Kisspeptin and Placebo Arms | 10 minutes |
| Second Phase Insulin Secretion | Average Change in Second Phase Insulin Secretion Between Kisspeptin and Placebo Arms | 2 hours |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Lippincott | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C106628 | KISS1 protein, human |
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| Kisspeptin-10 | Drug | Administration of kisspeptin-10 * 16 hr |
|
| Placebo | Drug | Administration of placebo *16 hr |
|