Acarbose and Older Adults With Postprandial Hypotension (PPH)

May 26, 2021 updated by: Kenneth Madden
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Precose
  • Glucobay
  • Prandase
  • Alpha-glucosidase inhibitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The postprandial cardiovascular response to a standardized meal compared between subjects with and without PPH
Time Frame: 2 years
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.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
The postprandial GLP-1 and GIP response to a standardized meal compared between subjects with and without PPH
2 years
The postprandial cardiovascular response between the Acarbose group and the Placebo group will be compared.
Time Frame: 2.5 years
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.
2.5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ambulatory blood pressure monitoring (Welch-Allyn, Ambulatory Blood Pressure Monitor(ABPM) 6100S) performed for 24 hours
Time Frame: 1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kenneth Madden

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kenneth M Madden, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H13-01316
  • G-13-0001812 (Other Grant/Funding Number: The Heart and Stroke Foundation of Canada (the Foundation))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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