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The present study investigates the involvement of the gut hormone glucose-dependent insulinotropic polypeptide (GIP) in the pathophysiology of postprandial hypotension (PPH)
The study is an exploratory, randomised, placebo-controlled, double-blind crossover study comprising two experimental days with an infusion of the GIP receptor antagonist, GIP(3-30)NH2 (NH2 is the aminogroup), and placebo (saline) during a 180-minute mixed meal test (MMT). Eighteen participants, men and women, with MMT confirmed PPH will be included in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GIPRA (Glucose-dependent Insulinotropic Polypepetide Receptor Antagonist) | Experimental | Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min |
|
| Saline | Placebo Comparator | Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous infusion of GIPRA | Other | Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min during experimental days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nadir systolic blood pressure (SBP) (mmHg) | Baseline | -45-0 minutes |
| Nadir systolic blood pressure (mmHg) | Nadir and time to nadir | 0-180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of PPH | (Yes/No) PPH is defined as either a drop in SBP >20 mmHg from baseline or SBP <90 mmHg | 0-180 minutes |
| Systolic blood pressure (mmHg) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose | Baseline | -45-0 minutes |
| Plasma glucose | Peak, nadir and iAUC | 0-180 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lise Wilki-Kurtzhals | University Hospital, Gentofte, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Metabolic Research | Copenhagen | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| C000619446 | gastric inhibitory polypeptide (3-30)-amide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Intravenous infusion of saline | Other | Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin during experimental days |
|
|
| -45-0 minutes |
| Systolic blood pressure (mmHg) | Peak, nadir and iAUC (incremental area under the curve) | 0-180 minutes |
| Diastolic blood pressure (mmHg) | Baseline | -45-0 minutes |
| Diastolic blood pressure (mmHg) | Peak, nadir and iAUC | 0-180 minutes |
| Heart rate (beats/min) | Baseline | -45-0 minutes |
| Heart rate (beats/min) | Peak, nadir and iAUC | 0-180 minutes |
| Stroke volumen (ml) | Baseline | -45-0 minutes |
| Stroke volumen (ml) | Peak, nadir and iAUC | 0-180 minutes |
| Cardiac output (l/min) | Baseline | -45-0 minutes |
| Cardiac output (l/min) | Peak, nadir and iAUC | 0-180 minutes |
| Gastric emptying rate | Plasma acetaminophen, baseline | -45-0 minutes |
| Gastric emptying rate | Plasma acetaminophen, peak and time to peak | 0-180 minutes |
| Plasma GIP(3-30)NH2 | Baseline | -45-0 minutes |
| Plasma GIP(3-30)NH2 | Peak and iAUC | 0-180 minutes |
| D017670 |
| Sodium Compounds |