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Metabolic Effects of Alcohol

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Alcohol

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Alcohol, Type 2 diabetes mellitus, Plama glucose, HDL cholesterol

Eligibility Criteria

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

Inclusion Criteria: Type 2 diabetes HbA1c 6.0-8.0% age > 40 years Exclusion Criteria: History of alcoholism or alcohol abuse liver disease blood pressure > 150/90

Sites / Locations

University of Minnesota

Outcomes

Primary Outcome Measures

Fasing plasma glucose

Fasting plasma HDL cholesterol

Secondary Outcome Measures

Episodes of hypoglycemia

Full Information

NCT ID

NCT00167115

First Posted

September 9, 2005

Last Updated

July 9, 2012

Sponsor

Bantle, John P., MD

1. Study Identification

Unique Protocol Identification Number

NCT00167115

Brief Title

Metabolic Effects of Alcohol

Official Title

Metabolic Effects of Alcohol in the Form of Wine in Persons With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

December 2004 (undefined)

Primary Completion Date

September 2005 (Actual)

Study Completion Date

September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bantle, John P., MD

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The hypotheses to be tested are 1) the use of alcohol in the form of wine with the evening meal will lower plasma glucose during the night and result in lower fasting plasma glucose the next morning; 2) the chronic use of alcohol in moderation in the form of wine will have beneficial effects on plasma lipids in type 2 diabetic subjects.

Detailed Description

The use of alcohol in moderation has been associated with reduced mortality rates, reduced risk of cardiovascular disease and reduced risk for type 2 diabetes. However, the effects of alcohol in persons with type 2 diabetes have not yet been defined. Moreover, the possibility of alcohol induced hypoglycemia remains a safety concern. Finally, little is known about the effects of alcohol on plasma lipids in people with diabetes. To address these issues, two substudies are proposed. The first substudy will examine the acute effects of alcohol in the form of wine at supper on postprandial and nocturnal glucose levels. The second substudy will examine the effects of alcohol in the form of wine consumed regularly for one month on plasma lipids. To test these hypotheses, 20 type 2 diabetics will be studied. In substudy 1, subjects will be admitted to the Clinical Research Center for a two day inpatient stay. Blood samples for plasma glucose and serum insulin will be obtained every two hours from 5:00 pm to 7:00 am. On one day, subjects will recieve 8 ounces of wine with dinner. On the other day, subjects will recieve 8 ounces of fruit juice with dinner. The primary endpoint of substudy 1 will be fasting plasma glucose. In substudy 2, subjects will be asked to consume 4-8 ounces of wine in the evening for one month and to abstain from wine and alcohol containing beverages for one month. Fasting blood samples will be obtained after the month of wine consumption and after the month of abstention from alcohol for measurement of fasting lipids. The primary endpoint of substudy 2 will be fasting HDL cholesterol.

6. Conditions and Keywords

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

Type 2 Diabetes Mellitus

Keywords

Alcohol, Type 2 diabetes mellitus, Plama glucose, HDL cholesterol

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Alcohol

Primary Outcome Measure Information:

Title

Fasing plasma glucose

Title

Fasting plasma HDL cholesterol

Secondary Outcome Measure Information:

Title

Episodes of hypoglycemia

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 2 diabetes HbA1c 6.0-8.0% age > 40 years Exclusion Criteria: History of alcoholism or alcohol abuse liver disease blood pressure > 150/90

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Bantle, MD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

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Metabolic Effects of Alcohol

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