CompletedNot Applicable

Effects of Water and Glucose Drinks on Cardiovascular Function in Subjects With and Without Postprandial Hypotension

8 participantsStarted 2013-04

Plain-language summary

To determine whether the changes in blood pressure (BP) which occur following meals in normal people and patients who have substantial falls in BP after a meal postprandial hypotension (PPH)) are associated with changes in cardiac function. Eligible subjects who have been previously diagnosed with PPH will report to the Queen Elizabeth Hospital, on two occasions, following an overnight fast. Subjects will be cannulated and have a BP cuff placed around their upper arm. Following this, subjects will ingest either a drink containing 75 grams of glucose and 150mg of a C13 Acetate (which is metabolised and excreted in the breath, enabling noninvasive measurements of gastric emptying), made up to 300mL water, or on the other study day, 300mL water alone. The order of the study days will be randomised. Following the drink, for 3 hours, measurements will be taken at regular intervals of BP, heart rate, breath samples (on the study day with the Acetate only), blood samples (for measurement of blood glucose and gut hormones) and transthoracic echocardiography (TTE) (for assessment of end systolic and diastolic cardiac volume, cardiac output, cardiac contractility and diastolic function). After the 3 hours of measurements, the cannula will be removed and subjects will be offered lunch prior to leaving the department. Following lunch, on one study day, subjects will have their autonomic nerve function tested noninvasively, using an ECG.

Who can participate

Age range

65 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Control subjects: subjects from this group will be healthy, with normal BMI. PPH subjects: Patients who have been diagnosed with PPH (defined as a fall in systolic blood pressure (BP) of \> 20mmHg within 2 hours of a meal). Exclusion Criteria: * No history of severe respiratory, cardiovascular, hepatic and/or renal disease, diabetes, are not taking any medication with effects on blood pressure or gastrointestinal function, have not donated blood for the past 12 weeks or been involved in any research projects for the past 3 months.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline systolic blood pressure over time.

Timeframe: time= 0 - 120 min

Trial details

NCT IDNCT02713412

SponsorRoyal Adelaide Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-10

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