Acarbose, Postprandial Hypotension and Type 2 Diabetes
|ClinicalTrials.gov Identifier: NCT02043886|
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : June 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Postprandial Hypotension||Drug: Acarbose Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Use of Acarbose to Treat Postprandial Hypotension in Older Adults With Type 2 Diabetes|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||May 2014|
Active Comparator: Acarbose
Acarbose 50mg by mouth at minute 0 of the Meal Test.
Acarbose 50 mg by mouth given during Meal Test
Other Name: Prandase, Precose
Placebo Comparator: Placebo
Placebo 1 tablet at 0 minutes of Meal Test.
Non active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043886
|Canada, British Columbia|
|VITALiTY Research Centre|
|Vancouver, British Columbia, Canada, V5Z1M9|
|Principal Investigator:||Kenneth M Madden, MD||University of British Columbia|