Blood Pressure Clinical Trial
Official title:
Cardiovascular Function and Postprandial Hypotension (PPH): Effect of an Oral Glucose Load on Cardiac Contractility, Cardiac Output, Diastolic Function and Endothelial Function - Relationship to Gastric Emptying
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years to 85 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Royal Adelaide Hospital |
Braden B, Adams S, Duan LP, Orth KH, Maul FD, Lembcke B, Hör G, Caspary WF. The [13C]acetate breath test accurately reflects gastric emptying of liquids in both liquid and semisolid test meals. Gastroenterology. 1995 Apr;108(4):1048-55. — View Citation
Chew CG, Bartholomeusz FD, Bellon M, Chatterton BE. Simultaneous 13C/14C dual isotope breath test measurement of gastric emptying of solid and liquid in normal subjects and patients: comparison with scintigraphy. Nucl Med Rev Cent East Eur. 2003;6(1):29-33. — View Citation
Gentilcore D, Nair NS, Vanis L, Rayner CK, Meyer JH, Hausken T, Horowitz M, Jones KL. Comparative effects of oral and intraduodenal glucose on blood pressure, heart rate, and splanchnic blood flow in healthy older subjects. Am J Physiol Regul Integr Comp Physiol. 2009 Sep;297(3):R716-22. doi: 10.1152/ajpregu.00215.2009. Epub 2009 Jun 24. — View Citation
Jones KL, Tonkin A, Horowitz M, Wishart JM, Carney BI, Guha S, Green L. Rate of gastric emptying is a determinant of postprandial hypotension in non-insulin-dependent diabetes mellitus. Clin Sci (Lond). 1998 Jan;94(1):65-70. — View Citation
Mossi S, Meyer-Wyss B, Beglinger C, Schwizer W, Fried M, Ajami A, Brignoli R. Gastric emptying of liquid meals measured noninvasively in humans with [13C]acetate breath test. Dig Dis Sci. 1994 Dec;39(12 Suppl):107S-109S. — View Citation
O'Donovan D, Feinle C, Tonkin A, Horowitz M, Jones KL. Postprandial hypotension in response to duodenal glucose delivery in healthy older subjects. J Physiol. 2002 Apr 15;540(Pt 2):673-9. — View Citation
Piha SJ. Cardiovascular autonomic reflex tests: normal responses and age-related reference values. Clin Physiol. 1991 May;11(3):277-90. — View Citation
Trahair LG, Vanis L, Gentilcore D, Lange K, Rayner CK, Horowitz M, Jones KL. Effects of variations in duodenal glucose load on blood pressure, heart rate, superior mesenteric artery blood flow and plasma noradrenaline in healthy young and older subjects. Clin Sci (Lond). 2012 Mar;122(6):271-9. doi: 10.1042/CS20110270. — View Citation
Vanis L, Gentilcore D, Hausken T, Pilichiewicz AN, Lange K, Rayner CK, Feinle-Bisset C, Meyer JH, Horowitz M, Jones KL. Effects of gastric distension on blood pressure and superior mesenteric artery blood flow responses to intraduodenal glucose in healthy older subjects. Am J Physiol Regul Integr Comp Physiol. 2010 Sep;299(3):R960-7. doi: 10.1152/ajpregu.00235.2010. Epub 2010 Jun 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline systolic blood pressure over time. | time= 0 min is defined as the consumption of either the experimental or control drink, i.e. outcome will be assessed for 2 hours. | time= 0 - 120 min | No |
Secondary | Change from baseline cardiac output as assessed by echocardiography, over time. | time= 0 min is defined as the consumption of either the experimental or control drink, i.e. outcome will be assessed for 2 hours. | time= 0 - 120 min | No |
Secondary | Change from baseline stroke volume as assessed by echocardiography, over time. | time= 0 min is defined as the consumption of either the experimental or control drink, i.e. outcome will be assessed for 2 hours. | time= 0 - 120 min | No |
Secondary | Change from baseline ejection fraction as assessed by echocardiography, over time. | time= 0 min is defined as the consumption of either the experimental or control drink, i.e. outcome will be assessed for 2 hours. | time= 0 - 120 min | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
Completed |
NCT05997303 -
Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT03918486 -
Caretaker vs. Routine Blood Pressure Sphygmomanometer
|
||
Completed |
NCT03410342 -
The Effects of Types of Fruits and Vegetables on Vascular Function
|
N/A | |
Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
Not yet recruiting |
NCT04087070 -
Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
|
||
Completed |
NCT03294928 -
Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers
|
N/A | |
Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
Completed |
NCT03997461 -
Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device
|
N/A | |
Completed |
NCT03290716 -
Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China
|
N/A | |
Recruiting |
NCT05196048 -
Blood Pressure Sensor of Watch-type Device With ECG Technology
|
||
Recruiting |
NCT06460233 -
Blood Pressure Changes After Bariatric Surgery
|
||
Terminated |
NCT03325933 -
Resistance Training and Cardiometabolic Health
|
N/A | |
Not yet recruiting |
NCT06405880 -
Pharmacist Case Finding and Intervention for Vascular Prevention Trial
|
N/A | |
Completed |
NCT02924454 -
Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol.
|
Phase 4 | |
Completed |
NCT02451059 -
Reducing Socioeconomic Disparities in Health at Pediatric Visits
|
N/A | |
Active, not recruiting |
NCT02670967 -
Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials
|
N/A | |
Completed |
NCT02271633 -
Nitrate Supplementation; Source
|
Phase 4 | |
Completed |
NCT02239744 -
Intervention Study on the Health Impact of Air Filters in Chinese Adults
|
N/A |