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| ID | Type | Description | Link |
|---|---|---|---|
| HAO 2013 | Other Identifier | Hors Appel d'Offres |
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The (PYR1)-apelin-13 is an endogenous peptide discovered relatively recently (1998). The apelin and its receptor, which is named apj, are expressed in many tissues including sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart tissue.
Recent work by the team of Prof. P.Valet (INSERM U1048, Toulouse) opened a new field of investigation, demonstrating for the first time in mouse models that apelin exerts a glucose-regulating in vivo action. The investigators propose a translational clinical research project whose goal is to provide the proof of concept of the favorable influence of apelin on insulin sensitivity in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apelin | Experimental | An apelin clamp in which an apelin infusion will be administered prior to reference clamp |
|
| Placebo | Placebo Comparator | A clamp reference during which a placebo solution (saline solution) will be administered prior to apelin clamp |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apelin | Drug | An apelin clamp in which an apelin infusion will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of glucose infusion | Measuring the difference between the rate of glucose infusion measured in the last 30 minutes of a hyperinsulinemic euglycemic clamp in the presence of a continuous infusion (PYR1)-apelin-13 infusion rate of glucose measured in the same conditions in the presence of a continuous infusion of placebo. | The last 30 minutes of a hyperinsulinemic euglycemic clamp |
| Measure | Description | Time Frame |
|---|---|---|
| Calculation of the index of insulin sensitivity (Si) | During 240 minutes at visits 2 and 3 | |
| Changes in the measurement of systolic blood pressure during each clamp | During 240 minutes at visits 2 and 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre GOURDY, Md, PhD | University Hospital of Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Toulouse | Toulouse | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28681996 | Result | Gourdy P, Cazals L, Thalamas C, Sommet A, Calvas F, Galitzky M, Vinel C, Dray C, Hanaire H, Castan-Laurell I, Valet P. Apelin administration improves insulin sensitivity in overweight men during hyperinsulinaemic-euglycaemic clamp. Diabetes Obes Metab. 2018 Jan;20(1):157-164. doi: 10.1111/dom.13055. Epub 2017 Aug 10. |
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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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| ID | Term |
|---|---|
| D000073861 | Apelin |
| ID | Term |
|---|---|
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
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| Placebo | Drug | A clamp reference during which a placebo solution (saline solution) will be administered |
|
| Changes in the measurement of diastolic blood pressure during each clamp | During 240 minutes at visits 2 and 3 |
| Changes in heart rate measurement during each clamp | During 240 minutes at visits 2 and 3 |
| Changes in ECG during each clamp | During 240 minutes at visits 2 and 3 |
| Clinical signs of intolerance / allergy / toxicity at visit 2,3 and 4 | During 240 minutes at visits 2 and 3 |
| Determination of plasma insulin at all sampling | During 240 minutes at visits 2 and 3 |
| Determination of plasma glucagon at all sampling times | During 240 minutes at visits 2 and 3 |
| Determination of plasma apelin at all sampling times | During 240 minutes at visits 2 and 3 |
| Determination of plasma leptin at all sampling times | During 240 minutes at visits 2 and 3 |
| Determination of plasma adiponectin at all sampling times | During 240 minutes at visits 2 and 3 |