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The primary aim of the study is to describe the effect of single dose of 10 micrograms (μg) exenatide given subcutaneously (s/c) on cortisol secretion. Secondary outcomes involve ACTH and glucose levels.
Exenatide is a short-acting Glucagon-Like Peptide receptor 1 (GLP-1 R) agonist.
The clinical trial is conducted in10 healthy volunteers. Each subject receives one dose of subcutaneous exenatide (10 μg). After that, hormonal and physiological changes are measured during two hours. The blood samples are taken in 30-minute intervals.
The primary endpoint is peak value of cortisol achieved during the 2 hours after drug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Experimental | Single injection of 10 μg Exenatide subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide Injection | Drug | Single injection of Exenatide 10μg subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol peak | Maximum concentration achieved after exenatide dose (any timepoint after injection) | every 30 minutes during 2 hours after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Adrenocorticotropin (ACTH) peak | Maximum concentration achieved after exenatide dose (any timepoint after injection) | every 30 minutes during 2 hours after injection |
| Glucose | Glucose values' area under the curve |
| Measure | Description | Time Frame |
|---|---|---|
| heart rate | Change in heart rate | every 30 minutes during 2 hours after injection |
| Blood pressure | Change in blood pressure | every 30 minutes during 2 hours after injection |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vallo Volke, MD,PhD | University of Tartu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Hospital | Tartu | Estonia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36800161 | Derived | Heinla K, Vasar E, Reppo I, Sedman T, Volke V. GLP-1 Receptor Agonists Induce Growth Hormone Secretion in Healthy Volunteers. Diabetes Ther. 2023 Apr;14(4):777-786. doi: 10.1007/s13300-023-01381-w. Epub 2023 Feb 17. |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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Single-group, open-label
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| Glucose measured every 30 minutes during 2 hours after injection |
| Growth hormone | Maximum concentration achieved after exenatide dose (any timepoint after injection) | every 30 minutes during 2 hours after injection |
| nausea | intensity of nausea in visual analogue scale | every 30 minutes during 2 hours after injection |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |