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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
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This project will describe the mechanisms of action and the relative contributions of GIP to changes in gastrointestinal blood flow induced by oral glucose and endogenous GIP with the use of a receptor antagonists GIP(3-30)NH2 in patients with type 2 diabetes.
Each participant will attend four independent randomised experimental days in the MRI-scanner with intravenous infusion (hormone/placebo) and oral ingestion (glucose/water): An intravenous infusion of saline or GIP(3-30)NH2 starts at time point -20 minutes.The infusions are combined with an oral glucose tolerance test (75 gram of glucose dissolved in 250 ml water ingested orally) at time point 0 minutes on two of the experimental days (with and without GIP(3-30)NH2).
MRI measurements are repeatedly performed and blood samples are drawn to be analysed for endocrine responses from the intestines, pancreas, and bones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline and oral water (SAL-WAT) | Placebo Comparator | Saline infusion, oral water ingestion |
|
| Saline infusion and oral glucose ingestion (SAL-GLU) | Active Comparator | Saline infusion, oral glucose ingestion |
|
| GIP(3-30)NH2 infusion and oral water ingestion (GIA-WAT) | Experimental | GIPR antagonist infusion, oral water ingestion |
|
| GIP(3-30)NH2 infusion and oral glucose ingestion (GIA-GLU) | Experimental | GIPR antagonist infusion, oral glucose ingestion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline / placebo | Other | NaCl (9 mg/ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (functional MRI) | Measued with phase-contrast MRI in ml/min | 80 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| GIP levels | Radioimmuno assay on plasma blood sample (pmol/L) | 80 minutes |
| GIP(3-30)NH2 levels | Radioimmuno assay on plasma blood sample (nmol/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42393405 | Derived | Rasmussen RS, Nielsen SW, Alstrup L, Larsson TSW, Hansen JK, Pedersen RP, Vestergaard MB, Haddock B, Johannesen HH, Larsson HBW, Holst JJ, Hartmann B, Rosenkilde MM, Asmar A, Andersen UB, Gasbjerg LS. GIP contributes to postprandial regulation of splanchnic blood supply in humans with type 2 diabetes: a randomised, single-blinded, placebo-controlled, crossover study. Diabetologia. 2026 Jul 2. doi: 10.1007/s00125-026-06788-1. Online ahead of print. | |
| 42373095 |
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Will share upon requests
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2024 | May 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Single blind, placebo controlled, randomized, crossover study
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| GIPR antagonist / study tool | Other | GIP(3-30)NH2 |
|
| 80 minutes |
| Glucose | Bedside measurement of whole blood sample (mmol/L) | 80 minutes |
| C-peptide | Electrochemiluminescence immunoassay of plasma blood sample (pmol/L) | 80 minutes |
| Insulin | Electrochemiluminescence immunoassay of plasma blood sample (pmol/L) | 80 minutes |
| Glucagon | Radioimmuno assay on plasma blood samples (pmol/L) | 80 minutes |
| Blood flow in portal vein | Measued with phase-contrast MRI in ml/min | 80 minutes |
| Blood flow in coeliac trunc | Measued with phase-contrast MRI in ml/min | 80 minutes |
| Blood flow in hepatic artery | Measued with phase-contrast MRI in ml/min | 80 minutes |
| Derived |
| Gasbjerg LS, Ostergaard FH, Rasmussen RS, Langberg LS, Nielsen SW, Alstrup L, Larsson TSW, Andersen UB, Larsson HBW, Asmar A, Haddock B, Vestergaard MB. Reproducibility of Splanchnic Blood Flow Measured Using Phase-Contrast MRI. NMR Biomed. 2026 Aug;39(8):e70348. doi: 10.1002/nbm.70348. |
| D004700 | Endocrine System Diseases |
| D017670 |
| Sodium Compounds |