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Wine Consumption and Glycemic Control (WGC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518334
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Brief Summary:
Many studies have reported that alcoholic beverage consumption, especially in the form of wine, reduces the risk of developing type 2 diabetes by as much as 40%. This association suggests that wine consumption may somehow improve the body's ability to control its blood glucose concentration. Indeed, it has been reported that when wine is consumed immediately prior to ingestion of glucose, the release of insulin is enhanced and blood glucose concentration is lowered. The mechanism of wine's effects on blood glucose concentration is unknown, but is likely related to its ethanol or antioxidant content. In this study, the investigators plan to test whether wine or plain ethanol (vodka) ingestion alters the control of blood glucose in subjects who have diabetes or pre-diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Alcohol consumption Not Applicable

Detailed Description:
Our central hypothesis is that improvement in glycemic control by acute consumption of wine is mediated by ethanol. Subjects will have type 2 diabetes, pre-diabetes, and be sedentary and obese (BMI >30). Subjects' glycemic control will be assessed by an oral glucose tolerance test (OGTT) at three different time points. One OGTT will occur shortly after consumption of red wine, the second after consumption of vodka containing the identical amount of ethanol as the wine treatment, and the third OGTT will occur shortly after consumption of an equal volume of water. The three OGTTs will be administered in random order.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Wine Consumption and Glycemic Control
Study Start Date : March 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Alcohol consumption
Alcohol consumption and wine consumption
Other: Alcohol consumption
28 grams (2 drinks) of ethanol will be consumed either in the form of wine or vodka.




Primary Outcome Measures :
  1. Oral glucose tolerance test [ Time Frame: 3 weeks ]
    Measurement of blood glucose taken every 15 minutes over a course of three hours.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • insulin resistant: diagnosed with pre-diabetes or fasting blood glucose >/= 97 mg/dL
  • T2D: diagnosed by primary care physician
  • at risk of type 2 diabetes (obesity and physically inactive)
  • age: 21-65

Exclusion Criteria:

  • smoking
  • insulin use (other than once daily)
  • physically active (>30 mins aerobic exercise two days/week)
  • recent (>3 mo) changes in medication use or dose
  • uncontrolled type two diabetes (HbA1C >10%)
  • advanced retinopathy or neuropathy
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518334


Locations
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United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65202
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: John P Thyfault, PhD University of Missouri-Columbia
Publications:
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Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02518334    
Other Study ID Numbers: Wine and GC
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Missouri-Columbia:
type two diabetes
glycemic control
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases