Acarbose, Postprandial Hypotension and Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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The Use of Acarbose to Treat Postprandial Hypotension in Older Adults With Type 2 Diabetes

Conditions
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Type 2 Diabetes, Postprandial Hypotension

Intervention / Treatment
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* Drug: Acarbose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 65 year and older Type 2 diabetes Exclusion Criteria: less than 65 years of age

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acarbose<br>Acarbose 50mg by mouth at minute 0 of the Meal Test. | Drug: Acarbose<br>* Acarbose 50 mg by mouth given during Meal Test<br>* Other names: Prandase, Precose;|
| Placebo Comparator: Placebo<br>Placebo 1 tablet at 0 minutes of Meal Test. | Drug: Placebo<br>* Non active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Postprandial Hypotension, Acarbose