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Metabolic Effects of Alcohol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute ( Bantle, John P., MD )
ClinicalTrials.gov Identifier:
NCT00167115
First received: September 9, 2005
Last updated: July 9, 2012
Last verified: July 2012

September 9, 2005
July 9, 2012
December 2004
September 2005   (final data collection date for primary outcome measure)
  • Fasing plasma glucose
  • Fasting plasma HDL cholesterol
Same as current
Complete list of historical versions of study NCT00167115 on ClinicalTrials.gov Archive Site
Episodes of hypoglycemia
Same as current
Not Provided
Not Provided
 
Metabolic Effects of Alcohol
Metabolic Effects of Alcohol in the Form of Wine in Persons With Type 2 Diabetes Mellitus

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: Alcohol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2005
September 2005   (final data collection date for primary outcome measure)

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

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00167115
0406M61001, Bantle1
No
University of Minnesota - Clinical and Translational Science Institute ( Bantle, John P., MD )
Bantle, John P., MD
Not Provided
Principal Investigator: John Bantle, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP