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
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Drug: Alcohol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Effects of Alcohol in the Form of Wine in Persons With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Fasing plasma glucose
  • Fasting plasma HDL cholesterol

Secondary Outcome Measures:
  • Episodes of hypoglycemia

Estimated Enrollment: 20
Study Start Date: December 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00167115

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Bantle, John P., MD
Investigators
Principal Investigator: John Bantle, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute ( Bantle, John P., MD )
ClinicalTrials.gov Identifier: NCT00167115     History of Changes
Other Study ID Numbers: 0406M61001, Bantle1
Study First Received: September 9, 2005
Last Updated: July 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Alcohol
Type 2 diabetes mellitus
Plama glucose
HDL cholesterol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014