Acarbose and Older Adults With Postprandial Hypotension

NCT ID: NCT01914133

Last Updated: 2021-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2021-05-31

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

Conditions

Other Specified Hypotension; Syncope

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

No Postprandial Hypotension (PPH)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo given prior to meal the standardized meal

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.

Group Type: ACTIVE_COMPARATOR

Acarbose

Intervention Type: DRUG

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

Interventions

Acarbose

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

Intervention Type: DRUG

Placebo

Placebo given prior to meal the standardized meal

Intervention Type: DRUG

Other Intervention Names

Glucobay; Precose; Prandase; Alpha-glucosidase inhibitor; Bayer Material No: 02839265; Acarbose Placebo Tablet

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kenneth Madden

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Madden

Division Head, VGH Division of Geriatric Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kenneth M Madden, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 40719030 (View on PubMed)

Other Identifiers

G-13-0001812

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H13-01316

Identifier Type: -

Identifier Source: org_study_id