Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Diabetes Association | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acarbose | Active Comparator | Acarbose 50mg by mouth at minute 0 of the Meal Test. |
|
| Placebo | Placebo Comparator | Placebo 1 tablet at 0 minutes of Meal Test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarbose | Drug | Acarbose 50 mg by mouth given during Meal Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Heart rate will be measured continuously by Finometer during the Meal Tests. Each Meal Test will take approximately 4 hours | 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) | 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) | 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 | 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. | 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. | Every 15 minutes during Meal Tests (approximately 4 hours) |
| Catecholamines |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth M Madden, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VITALiTY Research Centre | Vancouver | British Columbia | V5Z1M9 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Non active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test. |
|
Serum insulin levels will be collected every 15 minutes during the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays. |
| Continuously during Meal Test (approximately 4 hours) |
| D004700 | Endocrine System Diseases |