Acarbose and Older Adults With Postprandial Hypotension

NCT01914133 | Completed Phase 2 DMC

• 2 other identifiers: H13-01316G-13-0001812
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Specified Hypotension; Syncope

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (2)

• 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

  2 years

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

  2.5 years

Other Outcomes (1)

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

  1 day

Study Arms (3)

No Postprandial Hypotension (PPH)

NO INTERVENTION

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

Placebo

PLACEBO COMPARATOR

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

Acarbose

ACTIVE COMPARATOR

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

Interventions

Acarbose DRUG

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

Also known as: Glucobay, Precose, Prandase, Alpha-glucosidase inhibitor

Acarbose

Placebo DRUG

Placebo given prior to meal the standardized meal

Also known as: Bayer Material No: 02839265, Acarbose Placebo Tablet

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kenneth Madden: lead

Study Sites (1)

Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (1)

• Madden KM, Feldman B, Meneilly GS. The Effects of Acarbose on the Postprandial Hypotensive Response in Older Adults. Can J Aging. 2025 Sep;44(3):370-376. doi: 10.1017/S0714980825100056.

  PMID: 40719030 DERIVED

MeSH Terms

Conditions

Syncope

Interventions

Acarbose; Glycoside Hydrolase Inhibitors

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Kenneth M Madden, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Division Head, VGH Division of Geriatric Medicine

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: August 1, 2013
• Study Start: January 1, 2014
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)