Acarbose, Postprandial Hypotension and Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043886
• Other study ID #: H07-00510
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2014
• Last updated: June 27, 2017
• Start date: June 2007
• Est. completion date: May 2014

Study information

• Verified date: June 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• age 65 year and older

• Type 2 diabetes

Exclusion Criteria:

• less than 65 years of age

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypotension
• Postprandial Hypotension
• Type 2 Diabetes

Intervention

Drug:
• Acarbose
Acarbose 50 mg by mouth given during Meal Test
• Placebo
Non active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test.

Locations

Country	Name	City	State
Canada	VITALiTY Research Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Diabetes Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	Serum glucose	Serum glucose will be measured using a YSI (Yellow Spring Instruments) Stat 2300 Blood Glucose Analyzer	Every 15 minutes during Meal Tests
Primary	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)
Primary	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)
Primary	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)