Metabolic Effects of Alcohol
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol
Sponsored by
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
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
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
No
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
No
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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