Other Specified HypotensionPhase 2PPHNCT01914133
Acarbose and Older Adults With Postprandial Hypotension
A Phase 2 study testing Acarbose in people with Other Specified Hypotension and Syncope, run by Kenneth Madden at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Other Specified Hypotension, Syncope
- What is being tested?
- Acarbose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186
Vancouver, British Columbia, V5Z 1M9
About this study
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.
Read the 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
- Being tested
- Acarbose, Placebo
- Keywords
- Acarbose, PPH (Post Prandial Hypotension), Falls, Syncope, Elderly
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcarboseDrug
Also called Glucobay, Precose, Prandase, Alpha-glucosidase inhibitor
Acarbose 50 mg given during Meal Test and Acarbose 25 mg taken with first bite of the next 3 meals.
PlaceboDrug
Also called Bayer Material No: 02839265, Acarbose Placebo Tablet
Placebo given prior to meal the standardized meal
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The postprandial GLP-1 and GIP response to a standardized meal compared between subjects with and without PPH
Measured: 2 years
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.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startJan 2014
- Primary completionMay 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Specified HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Madden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenneth Madden, University of British Columbia
- Investigators
- Kenneth M Madden, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914133
- Sponsor's protocol ID
- H13-01316
- Other IDs
- G-13-0001812
- Acronym
- PPH
- Status last verified
- May 2021
- First submitted
- 22 Jul 2013
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40719030
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acarbose and Older Adults With Postprandial Hypotension
- ClinicalTrials.gov ID
- NCT01914133
- Acronym / sponsor ID
- PPH / H13-01316
- Conditions
- Other Specified Hypotension, Syncope
- Keywords
- Acarbose, PPH (Post Prandial Hypotension), Falls, Syncope, Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kenneth MaddenUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Postprandial Hypotension (PPH) | No intervention | –Screening Meal Test performed and subject does not meet criteria for Postprandial Hypotension (PPH). |
| Placebo | Placebo comparator | Drug: PlaceboScreening 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. |
| Acarbose | Active comparator | Drug: AcarboseScreening 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcarboseAlso: Glucobay, Precose, Prandase, Alpha-glucosidase inhibitorAcarbose 50 mg given during Meal Test and Acarbose 25 mg taken with first bite of the next 3 meals. | Drug | Acarbose |
| PlaceboAlso: Bayer Material No: 02839265, Acarbose Placebo TabletPlacebo given prior to meal the standardized meal | Drug | Placebo |
Primary outcome
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 secondary outcomes
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 cardiovascular response between the Acarbose group and the Placebo group will be compared.
Time frame: 2.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Derived from this study: PubMed 40719030Madden 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth M Madden, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acarbose in people with Other Specified Hypotension and Syncope, run by Kenneth Madden at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The postprandial cardiovascular response to a standardized meal compared between subjects with and without PPH (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01914133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.