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Additional Glucose Lowering and Anti-Inflammatory Effects by Acarbose and Alcohol in Subjects With Impaired Glucose Tolerance or Mild Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Impaired Glucose Tolerance

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Acarbose

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring diabetes, acarbose, alcohol, inflammation, oxidative stress, Mild diabetes mellitus

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with mild diabetes without prior medications or impaired glucose tolerance

Exclusion Criteria:

Pregnancy
Recent major cardiac, renal and hepatic disease
Intolerance to alcohol
Allergy to acarbose treatment

Sites / Locations

Taichung Veterans General HospitalRecruiting

Outcomes

Primary Outcome Measures

Postprandial hyperglycemia

Secondary Outcome Measures

Postprandial inflammatory responses

Postprandial oxidative stress

Full Information

NCT ID

NCT00417950

First Posted

January 1, 2007

Last Updated

January 3, 2007

Sponsor

Taichung Veterans General Hospital

Collaborators

Tri-Service General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00417950

Brief Title

Additional Glucose Lowering and Anti-Inflammatory Effects by Acarbose and Alcohol in Subjects With Impaired Glucose Tolerance or Mild Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Taichung Veterans General Hospital

Collaborators

Tri-Service General Hospital

4. Oversight

5. Study Description

Brief Summary

To understand if acarbose, an alpha-glucosidase inhibitor usually for treating diabetes, will further lower post meal glucose and inflammatory state when taking together with moderate amount of alcohol during meal tolerance test in subjects with impaired glucose tolerance or mild diabetes.

6. Conditions and Keywords

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

Diabetes Mellitus, Impaired Glucose Tolerance

Keywords

diabetes, acarbose, alcohol, inflammation, oxidative stress, Mild diabetes mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Acarbose

Primary Outcome Measure Information:

Title

Postprandial hyperglycemia

Secondary Outcome Measure Information:

Title

Postprandial inflammatory responses

Title

Postprandial oxidative stress

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with mild diabetes without prior medications or impaired glucose tolerance Exclusion Criteria: Pregnancy Recent major cardiac, renal and hepatic disease Intolerance to alcohol Allergy to acarbose treatment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

I Te Lee, MD, MS

Phone

886-4-23592525

Ext

3065

itlee@vghtc.gov.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wayne H Sheu, MD, PhD

Organizational Affiliation

Taichung Veterans General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taichung Veterans General Hospital

City

Taichung

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wayne H Sheu, MD, PhD

Phone

886-4-23592525

Ext

3068

whhsheu@vghtc.gov.tw

First Name & Middle Initial & Last Name & Degree

Wayne H Sheu, MD, PhD

First Name & Middle Initial & Last Name & Degree

I Te Lee, MD, MS

12. IPD Sharing Statement

Learn more about this trial

Additional Glucose Lowering and Anti-Inflammatory Effects by Acarbose and Alcohol in Subjects With Impaired Glucose Tolerance or Mild Type 2 Diabetes

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