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| Name | Class |
|---|---|
| Gentofte Hospital, Denmark | UNKNOWN |
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This project will characterize the physiological effect of the hormones, GIP-, GLP-1- and GLP-2 infusions in a group of individuals that are carriers of GIP-, GLP-1- and GLP-2 receptor gene variants, respectively.
Participants with mutations in their GLP-1- and GIP receptor will attend five randomized experimental days, A1, A2, B, C and D. On day A1 an oral glucose tolerance test (OGTT) will be performed, and on day A2, an intravenous isoglycaemic glucose infusion (IIGI) will be performed. On experimental day B and C, the study participants will receive GLP-1 and GIP hormones, respectively, under stable glucose infusions and on experimental day D, they will receive infusion of salt water (placebo) under stable glucose infusion.
Participants with mutations in their GLP-2 receptor will attend three randomized experimental days, E, F and G. A mixed meal test (MMT) will be performed on day E, an infusion with GLP-2 during fasting blood glucose levels will be performed on day F, and infusion with salt water (placebo) during fasting blood glucose levels will be performed on day G.
Additionally, a DXA scan and arginine test will be performed on all study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GIPR variant carriers | Active Comparator | Inidividuals with GIPR variants: Determination of the incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp. |
|
| GIPR variant carrier controls | Placebo Comparator | Healthy matched individuals: Determination of incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp. |
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| GLP-1R variant carrier | Active Comparator | Individuals with GLP-1R variants: Determination of incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp |
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| GLP-1R variant carrier controls | Placebo Comparator | Healthy matched individuals: Determination of incretin effect, and the insulinotropic actions of to GIP and GLP-1 infusions during hyperglycemic clamp. |
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| GLP-2R variant carrier | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GIP(1-42) | Drug | Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| For GIP- and GLP-1 receptor variants: Insulinotropic effect (C-peptide) | Blood sample | 240 minutes |
| For GLP-2 receptor variants: CTX (bone resorption marker) | Blood sample | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| GIP levels | Blood sample | 240 minutes |
| GLP-1 levels | Blood sample | 240 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Metabolic Research, Gentofte Hospital | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| C101760 | gastric inhibitory polypeptide (1-42) |
| D052216 | Glucagon-Like Peptide 1 |
| ID | Term |
|---|---|
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
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Single-blind, randomized, crossover study
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Individuals with GLP-2R variants: Determination of bone resorption marker levels (CTX) and response to GLP-2 infusions during fasting blood glucose levels
|
| GLP-2R variant carrier control | Placebo Comparator | Healthy matched individuals: Determination of bone resorption marker levels (CTX) and response to GLP-2 infusions during fasting blood glucose levels |
|
| GLP-1 | Drug | Infusion |
|
| GLP-2 | Drug | Infusion |
|
| Placebo | Other | Saline |
|
| GLP-2 levels | Blood sample | 240 minutes |
| CTX (bone resorption marker) | Blood sample | 240 minutes |
| P1NP (bone formation marker) | Blood Sample | 240 minutes |
| Heart rate | Beats/minute | 240 minutes |
| Insulin | Blood sample | 240 minutes |
| Glucagon | Blood sample | 240 minutes |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |