Wine Consumption and Glycemic Control (WGC)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol consumption
Sponsored by

About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring type two diabetes, glycemic control
Eligibility 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
Sites / Locations
- University of Missouri
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Alcohol consumption
Arm Description
Alcohol consumption and wine consumption
Outcomes
Primary Outcome Measures
Oral glucose tolerance test
Measurement of blood glucose taken every 15 minutes over a course of three hours.
Secondary Outcome Measures
Full Information
NCT ID
NCT02518334
First Posted
February 8, 2012
Last Updated
October 24, 2017
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02518334
Brief Title
Wine Consumption and Glycemic Control
Acronym
WGC
Official Title
Wine Consumption and Glycemic Control
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
type two diabetes, glycemic control
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alcohol consumption
Arm Type
Experimental
Arm Description
Alcohol consumption and wine consumption
Intervention Type
Other
Intervention Name(s)
Alcohol consumption
Intervention Description
28 grams (2 drinks) of ethanol will be consumed either in the form of wine or vodka.
Primary Outcome Measure Information:
Title
Oral glucose tolerance test
Description
Measurement of blood glucose taken every 15 minutes over a course of three hours.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Thyfault, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15161790
Citation
Avogaro A, Watanabe RM, Dall'Arche A, De Kreutzenberg SV, Tiengo A, Pacini G. Acute alcohol consumption improves insulin action without affecting insulin secretion in type 2 diabetic subjects. Diabetes Care. 2004 Jun;27(6):1369-74. doi: 10.2337/diacare.27.6.1369.
Results Reference
background
Learn more about this trial
Wine Consumption and Glycemic Control
We'll reach out to this number within 24 hrs