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Acarbose and Older Adults With Postprandial Hypotension (PPH)

Primary Purpose

Other Specified Hypotension, Syncope

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Acarbose

Placebo

About this trial

This is an interventional treatment trial for Other Specified Hypotension focused on measuring Acarbose, PPH (Post Prandial Hypotension), Falls, Syncope, Elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

Active Comparator

Arm Label

No Postprandial Hypotension (PPH)

Placebo

Acarbose

Arm Description

Screening Meal Test performed and subject does not meet criteria for Postprandial Hypotension (PPH).

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.

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.

Outcomes

Primary Outcome Measures

The postprandial cardiovascular response to a standardized meal compared between subjects with and without PPH

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

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.

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.

Full Information

NCT ID

NCT01914133

First Posted

July 22, 2013

Last Updated

May 26, 2021

Sponsor

Kenneth Madden

1. Study Identification

Unique Protocol Identification Number

NCT01914133

Brief Title

Acarbose and Older Adults With Postprandial Hypotension

Acronym

PPH

Official Title

Acarbose and Older Adults With Postprandial Hypotension

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

January 2014 (Actual)

Primary Completion Date

May 2021 (Actual)

Study Completion Date

May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kenneth Madden

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Other Specified Hypotension, Syncope

Keywords

Acarbose, PPH (Post Prandial Hypotension), Falls, Syncope, Elderly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No Postprandial Hypotension (PPH)

Arm Type

No Intervention

Arm Description

Screening Meal Test performed and subject does not meet criteria for Postprandial Hypotension (PPH).

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Acarbose

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Acarbose

Other Intervention Name(s)

Glucobay, Precose, Prandase, Alpha-glucosidase inhibitor

Intervention Description

Acarbose 50 mg given during Meal Test and Acarbose 25 mg taken with first bite of the next 3 meals.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Bayer Material No: 02839265, Acarbose Placebo Tablet

Intervention Description

Placebo given prior to meal the standardized meal

Primary Outcome Measure Information:

Title

The postprandial cardiovascular response to a standardized meal compared between subjects with and without PPH

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

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

Description

The postprandial GLP-1 and GIP response to a standardized meal compared between subjects with and without PPH

Time Frame

2 years

Title

The postprandial cardiovascular response between the Acarbose group and the Placebo group will be compared.

Description

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.

Time Frame

2.5 years

Other Pre-specified Outcome Measures:

Title

ambulatory blood pressure monitoring (Welch-Allyn, Ambulatory Blood Pressure Monitor(ABPM) 6100S) performed for 24 hours

Description

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.

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth M Madden, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Acarbose and Older Adults With Postprandial Hypotension

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