Type 2 DiabetesPhase 2NCT02043886
Acarbose, Postprandial Hypotension and Type 2 Diabetes
A Phase 2 study testing Acarbose in people with Type 2 Diabetes and Postprandial Hypotension, run by University of British Columbia at 1 site in Canada.
Trial summary
Postprandial hypotension carries a risk of significant morbidity and morbidity including syncope, falls, dizziness, fatigue, stroke and myocardial infarction. Current therapy consists of dietary manipulation (smaller meals) caffeine and octreotide injections all of which are suboptimal and poorly studied. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type 2 Diabetes, Postprandial Hypotension
- What is being tested?
- Acarbose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2007to May 2014
- 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
- age 65 year and older
- Type 2 diabetes
Who cannot join
- less than 65 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Acarbose to Treat Postprandial Hypotension in Older Adults With Type 2 Diabetes
Postprandial hypotension carries a risk of significant morbidity and morbidity including syncope, falls, dizziness, fatigue, stroke and myocardial infarction. Current therapy consists of dietary manipulation (smaller meals) caffeine and octreotide injections all of which are suboptimal and poorly studied.
The study hypothesis is that administration of Acarbose will decrease the drop in blood pressure and increase in heart rate in response to food in people with Type 2 diabetes.
Read more
Acarbose suppresses postprandial glycemia be slowing digestion in the small intestine and delaying gastric emptying.
This is a placebo-controlled cross over study involving 2 - 4 hour Meal Tests. During the meal tests heart rate, blood pressure, cerebral artery velocity will be measured. During one meal test subjects will receive Acarbose 50 mg po and during the other will receive placebo. Order of treatment assignment will be done in randomized fashion. A total of approximately 200 cc of blood will be drawn during each meal test.
- Conditions
- Type 2 Diabetes, Postprandial Hypotension
- Being tested
- Acarbose, Placebo
- Keywords
- Type 2 Diabetes, Postprandial Hypotension, Acarbose
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcarboseDrug
Also called Prandase, Precose
Acarbose 50 mg by mouth given during Meal Test
PlaceboDrug
Non active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test.
| Study group | Role | What they receive |
|---|---|---|
| Acarbose | Active comparator | Acarbose 50mg by mouth at minute 0 of the Meal Test. Receives: Drug: Acarbose |
| Placebo | Placebo comparator | Placebo 1 tablet at 0 minutes of Meal Test. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate will be measured continuously by Finometer during the Meal Tests. Each Meal Test will take approximately 4 hours
Measured: continuously during Meal Test; about 4 hours
Blood pressure
Blood pressure will be measured continuously by Finometer during each of the Meal Tests (approximately 4 hours)
Measured: Continuously during Meal Tests (approximately 4 hours)
Middle cerebral artery velocity
Middle cerebral artery velocity will be measure continuously by transcranial doppler during the Meal Tests (approximately 4 hours)
Measured: continuously during Meal Tests (approximately 4 hours)
Serum glucose
Serum glucose will be measured using a YSI (Yellow Spring Instruments) Stat 2300 Blood Glucose Analyzer
Measured: Every 15 minutes during Meal Tests
Serum insulin
Serum insulin levels will be collected every 15 minutes during the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.
Measured: Every 15 minutes during Meal Tests (approximately 4 hours)
Serum peptides: GIP (gastric inhibitory polypeptide) and GLP-1 (glucagon like peptide)
Serum peptides will be collected every 15 minutes for the duration of the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.
Measured: Every 15 minutes during Meal Tests (approximately 4 hours)
Catecholamines
Serum insulin levels will be collected every 15 minutes during the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.
Measured: Continuously during Meal Test (approximately 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJun 2007
- Primary completionJan 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Diabetes Association
- Responsible party
- Principal 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
- NCT02043886
- Sponsor's protocol ID
- H07-00510
- Status last verified
- Jun 2017
- First submitted
- 21 Jan 2014
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Acarbose to Treat Postprandial Hypotension in Older Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02043886
- Acronym / sponsor ID
- H07-00510
- Conditions
- Type 2 Diabetes, Postprandial Hypotension
- Keywords
- Type 2 Diabetes, Postprandial Hypotension, Acarbose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Diabetes Association
- Study start
- Jun 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Jan 2014 (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.
Postprandial hypotension carries a risk of significant morbidity and morbidity including syncope, falls, dizziness, fatigue, stroke and myocardial infarction. Current therapy consists of dietary manipulation (smaller meals) caffeine and octreotide injections all of which are suboptimal and poorly studied.
The study hypothesis is that administration of Acarbose will decrease the drop in blood pressure and increase in heart rate in response to food in people with Type 2 diabetes.
Acarbose suppresses postprandial glycemia be slowing digestion in the small intestine and delaying gastric emptying.
This is a placebo-controlled cross over study involving 2 - 4 hour Meal Tests. During the meal tests heart rate, blood pressure, cerebral artery velocity will be measured. During one meal test subjects will receive Acarbose 50 mg po and during the other will receive placebo. Order of treatment assignment will be done in randomized fashion. A total of approximately 200 cc of blood will be drawn during each meal test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acarbose | Active comparator | Drug: AcarboseAcarbose 50mg by mouth at minute 0 of the Meal Test. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1 tablet at 0 minutes of Meal Test. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- age 65 year and older
- Type 2 diabetes
Key exclusion criteria (1 listed)
- less than 65 years of age
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: Prandase, PrecoseAcarbose 50 mg by mouth given during Meal Test | Drug | Acarbose |
| PlaceboNon active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test. | Drug | Placebo |
Primary outcome
Heart rate
Time frame: continuously during Meal Test; about 4 hours
Heart rate will be measured continuously by Finometer during the Meal Tests. Each Meal Test will take approximately 4 hours
Blood pressure
Time frame: Continuously during Meal Tests (approximately 4 hours)
Blood pressure will be measured continuously by Finometer during each of the Meal Tests (approximately 4 hours)
Middle cerebral artery velocity
Time frame: continuously during Meal Tests (approximately 4 hours)
Middle cerebral artery velocity will be measure continuously by transcranial doppler during the Meal Tests (approximately 4 hours)
Serum glucose
Time frame: Every 15 minutes during Meal Tests
Serum glucose will be measured using a YSI (Yellow Spring Instruments) Stat 2300 Blood Glucose Analyzer
Serum insulin
Time frame: Every 15 minutes during Meal Tests (approximately 4 hours)
Serum insulin levels will be collected every 15 minutes during the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.
Serum peptides: GIP (gastric inhibitory polypeptide) and GLP-1 (glucagon like peptide)
Time frame: Every 15 minutes during Meal Tests (approximately 4 hours)
Serum peptides will be collected every 15 minutes for the duration of the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.
Catecholamines
Time frame: Continuously during Meal Test (approximately 4 hours)
Serum insulin levels will be collected every 15 minutes during the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.
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 Jun 2017.
- Individual participant dataSharing planned: No
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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 Type 2 Diabetes and Postprandial Hypotension, run by University of British Columbia 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 2 inclusion and 1 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 Jun 2017. 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?
Heart rate (time frame: continuously during Meal Test; about 4 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2017.