Acarbose and Older Adults With Postprandial Hypotension (PPH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01914133
First received: July 22, 2013
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

The current proposal will determine if blocking carbohydrate intake in the small intestine with Acarbose can be a possible therapy for older adults with (PPH) Post Prandial Hypotension (a drop of blood pressure after eating), which can result in falls.


Condition Intervention Phase
Other Specified Hypotension
Syncope
Drug: Acarbose
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acarbose and Older Adults With Postprandial Hypotension

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The postprandial cardiovascular response to a standardized meal compared between subjects with and without PPH [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The postprandial cardiovascular response (mesenteric blood flow, adrenergic response, cerebral blood flow) to a standardized meal will be compared between n=30 subjects with PPH and n= 30 subjects without PPH.


Secondary Outcome Measures:
  • The postprandial glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP) response to a standardized meal compared between subjects with and without PPH [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The postprandial GLP-1 and GIP response to a standardized meal compared between subjects with and without PPH

  • The postprandial cardiovascular response between the Acarbose group and the Placebo group will be compared. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    The postprandial cardiovascular response (mesenteric blood flow, adrenergic response, cerebral blood flow) to a standardized meal between the Acarbose group and the Placebo group will be compared.


Other Outcome Measures:
  • ambulatory blood pressure monitoring (Welch-Allyn, Ambulatory Blood Pressure Monitor(ABPM) 6100S) performed for 24 hours [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Starting the day following each meal test, each subject with PPH will take either acarbose 25 mg po tid (prior to each meal) or placebo po tid for one day. During this 24 hour period, each subject will undergo 24 Hr-ABPM (starting at 7 ante meridian (AM) the following day). Each subject will have ambulatory blood pressure monitoring (Welch-Allyn, ABPM 6100S) performed for 24 hours. Each subject will carry a logbook to record time of activity and all meals. Each subject will be given a watch synchronized to the 24-hour blood pressure monitor.


Estimated Enrollment: 240
Study Start Date: January 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Postprandial Hypotension (PPH)
Screening Meal Test performed and subject does not meet criteria for Postprandial Hypotension (PPH).
Placebo Comparator: Placebo
Screening Meal Test performed and subject meets criteria for Postprandial Hypotension (PPH). At second Meal Test subject will receive a placebo and will take a placebo with the first bite of the next 3 meals.
Drug: Placebo
Placebo given prior to meal the standardized meal
Other Names:
  • Bayer Material No: 02839265
  • Acarbose Placebo Tablet
Active Comparator: Acarbose
Screening Meal Test performed and subject meets criteria for Postprandial Hypotension. During the second Meal Test subject will receive Acarbose 50mg and will take Acarbose 25mg with first bite of each of the next 3 meals.
Drug: Acarbose
Acarbose 50 mg given during Meal Test and Acarbose 25 mg taken with first bite of the next 3 meals.
Other Names:
  • Glucobay
  • Precose
  • Prandase
  • Alpha-glucosidase inhibitor

Detailed Description:

Blocking the absorption of carbohydrates at the brush border of the small intestine with acarbose (an alpha-glucosidase inhibitor) seems a promising possibility as a potential therapeutic agent. Although designed as a second-line diabetes drug, this medication has very little risk of hypoglycemia in older adults. In fact the risk of hypoglycemia is extremely low even in patients concurrently taking concurrent hypoglycemia agents (including insulin), and there is almost no risk of hypoglycemia in subjects not on other diabetes medications. Acarbose suppresses postprandial glycemia by slowing small intestinal digestion and absorption of carbohydrate, and has been shown to slow gastric emptying Acarbose has yet to be examined in a prospective fashion in older adults, despite the prevalence of PPH in this patient population. Preliminary, pilot work done in our laboratory on older adults with PPH has demonstrated that the hypotensive response over 90 minutes to a standardized meal was significantly reduced by the administration of acarbose

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • be 65 years of age or older,
  • be a non-smoker for at least 5 years
  • be referred to the falls clinic at Vancouver General Hospital
  • have a Folstein test of cognition > 25/30 to ensure meal log-book compliance

Exclusion Criteria:

  • no oral or swallowing issues that would prevent a Meal Test
  • subject requiring dialysis due to end-stage renal failure will be excluded
  • subjects with evidence on history, physical or blood work of hepatic disease will be excluded since elevated serum transaminases are a potential adverse effect of acarbose
  • cannot currently be taking an alpha-glucosidase inhibitor
  • cannot have had allergic reactions to alpha-glucosidase inhibitors in the past
  • Due to the fact that acarbose is renally excreted, all subjects must have a Creatine Clearance of greater than 25 ml/min
  • Subjects with a past history of inflammatory bowel disease, intestinal obstruction, ileus and peptic ulcer disease will be excluded
  • Subjects taking carbohydrate-splitting enzymes (such as amylase) will be excluded
  • Subjects with chronic respiratory issues requiring treatment will be excluded
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914133

Contacts
Contact: Gale R Tedder, RN, BSN 604-875-5115 gale.tedder@vch.ca
Contact: Chris Lockhart, BSc 604-875-4111 ext 68535 chris.lockhart@vch.ca

Locations
Canada, British Columbia
Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186 Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Gale Tedder, RN, BSN    604-875-5115    gale.tedder@vch.ca   
Contact: Chris Lockhart, BSc    604-875-4111 ext 68535    chris.lockhart@vch.ca   
Principal Investigator: Kenneth M Madden, MD MSc FRCPC         
Sub-Investigator: Graydon Meneilly, MD, FRCPC         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Kenneth M Madden, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01914133     History of Changes
Other Study ID Numbers: H13-01316, G-13-0001812
Study First Received: July 22, 2013
Last Updated: July 16, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Acarbose
PPH (Post Prandial Hypotension)
Falls
Syncope
Elderly

Additional relevant MeSH terms:
Hypotension
Syncope
Vascular Diseases
Cardiovascular Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acarbose
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014