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

NCT02713412 | Completed

• 1 other identifier: HREC/12/TQEHLMH/106
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Autonomic Nervous System Diseases; Baroreflex Failure; Blood Pressure; Hypotension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change from baseline cardiac output as assessed by echocardiography, over time.

  time= 0 - 120 min

• Change from baseline stroke volume as assessed by echocardiography, over time.

  time= 0 - 120 min

• Change from baseline ejection fraction as assessed by echocardiography, over time.

  time= 0 - 120 min

Study Arms (2)

Glucose

EXPERIMENTAL

75g glucose and 150mg C13-acetate in 300ml water

Other: Glucose

Control

PLACEBO COMPARATOR

300ml water

Other: Water

Interventions

Glucose OTHER

75g glucose and 150 mg of 13C-acetate made up to 300 ml with water

Glucose

Water OTHER

300ml water

Control

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Adelaide Hospital: lead

Related Publications (9)

• 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.

  PMID: 19553500 BACKGROUND

• 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. doi: 10.1042/cs0940065.

  PMID: 9505868 BACKGROUND

• 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. doi: 10.1113/jphysiol.2001.013442.

  PMID: 11956353 BACKGROUND

• 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.

  PMID: 21942924 BACKGROUND

• 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.

  PMID: 20554933 BACKGROUND

• Braden B, Adams S, Duan LP, Orth KH, Maul FD, Lembcke B, Hor 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. doi: 10.1016/0016-5085(95)90202-3.

  PMID: 7698571 BACKGROUND

• 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.

  PMID: 14600930 BACKGROUND

• 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. doi: 10.1007/BF02300386.

  PMID: 7995201 BACKGROUND

• Piha SJ. Cardiovascular autonomic reflex tests: normal responses and age-related reference values. Clin Physiol. 1991 May;11(3):277-90. doi: 10.1111/j.1475-097x.1991.tb00459.x.

  PMID: 1893685 BACKGROUND

MeSH Terms

Conditions

Autonomic Nervous System Diseases; Hypotension

Interventions

Glucose; Water

Condition Hierarchy (Ancestors)

Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Karen L Jones, PhD

  karen.jones@adelaide.edu.au

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: March 18, 2016
• Study Start: April 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 18, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share