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Acarbose, Postprandial Hypotension and Type 2 Diabetes

Primary Purpose

Type 2 Diabetes, Postprandial Hypotension

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Acarbose

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Postprandial Hypotension, Acarbose

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age 65 year and older
Type 2 diabetes

Exclusion Criteria:

less than 65 years of age

Sites / Locations

VITALiTY Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Acarbose

Placebo

Arm Description

Acarbose 50mg by mouth at minute 0 of the Meal Test.

Placebo 1 tablet at 0 minutes of Meal Test.

Outcomes

Primary Outcome Measures

Heart rate

Heart rate will be measured continuously by Finometer during the Meal Tests. Each Meal Test will take approximately 4 hours

Blood pressure

Blood pressure will be measured continuously by Finometer during each of the 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)

Serum glucose

Serum glucose will be measured using a YSI (Yellow Spring Instruments) Stat 2300 Blood Glucose Analyzer

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02043886

First Posted

January 21, 2014

Last Updated

June 27, 2017

Sponsor

University of British Columbia

Collaborators

Canadian Diabetes Association

1. Study Identification

Unique Protocol Identification Number

NCT02043886

Brief Title

Acarbose, Postprandial Hypotension and Type 2 Diabetes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

Collaborators

Canadian Diabetes Association

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Postprandial Hypotension

Keywords

Type 2 Diabetes, Postprandial Hypotension, Acarbose

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acarbose

Arm Type

Active Comparator

Arm Description

Acarbose 50mg by mouth at minute 0 of the Meal Test.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo 1 tablet at 0 minutes of Meal Test.

Intervention Type

Drug

Intervention Name(s)

Acarbose

Other Intervention Name(s)

Prandase, Precose

Intervention Description

Acarbose 50 mg by mouth given during Meal Test

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Non active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test.

Primary Outcome Measure Information:

Title

Heart rate

Description

Heart rate will be measured continuously by Finometer during the Meal Tests. Each Meal Test will take approximately 4 hours

Time Frame

continuously during Meal Test; about 4 hours

Title

Blood pressure

Description

Blood pressure will be measured continuously by Finometer during each of the Meal Tests (approximately 4 hours)

Time Frame

Continuously during Meal Tests (approximately 4 hours)

Title

Middle cerebral artery velocity

Description

Middle cerebral artery velocity will be measure continuously by transcranial doppler during the Meal Tests (approximately 4 hours)

Time Frame

continuously during Meal Tests (approximately 4 hours)

Title

Serum glucose

Description

Serum glucose will be measured using a YSI (Yellow Spring Instruments) Stat 2300 Blood Glucose Analyzer

Time Frame

Every 15 minutes during Meal Tests

Title

Serum insulin

Description

Serum insulin levels will be collected every 15 minutes during the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.

Time Frame

Every 15 minutes during Meal Tests (approximately 4 hours)

Title

Serum peptides: GIP (gastric inhibitory polypeptide) and GLP-1 (glucagon like peptide)

Description

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.

Time Frame

Every 15 minutes during Meal Tests (approximately 4 hours)

Title

Catecholamines

Description

Serum insulin levels will be collected every 15 minutes during the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.

Time Frame

Continuously during Meal Test (approximately 4 hours)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth M Madden, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

VITALiTY Research Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z1M9

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Acarbose, Postprandial Hypotension and Type 2 Diabetes

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