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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02518334
Other study ID # Wine and GC
Secondary ID
Status Completed
Phase N/A
First received February 8, 2012
Last updated October 24, 2017
Start date March 2012
Est. completion date March 2015

Study information

Verified date October 2017
Source University of Missouri-Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Alcohol consumption
28 grams (2 drinks) of ethanol will be consumed either in the form of wine or vodka.

Locations

Country Name City State
United States University of Missouri Columbia Missouri

Sponsors (1)

Lead Sponsor Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Oral glucose tolerance test Measurement of blood glucose taken every 15 minutes over a course of three hours. 3 weeks
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