Postprandial Hypotension, Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Postprandial Hypotension, Acarbose
Brief 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. 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.
Interventions
DRUGAcarbose
Acarbose 50 mg by mouth given during Meal Test
DRUGPlacebo
Non active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test.
Sponsors
Canadian Diabetes Association
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 65 year and older * Type 2 diabetes
Exclusion criteria
* less than 65 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 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 | 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 | 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 | Every 15 minutes during Meal Tests | Serum glucose will be measured using a YSI (Yellow Spring Instruments) Stat 2300 Blood Glucose Analyzer |
| Serum insulin | 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) | 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 | 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. |
Countries
Canada
Outcome results
None listed