NCT02518334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

February 8, 2012

Last Update Submit

October 24, 2017

Conditions

Keywords

type two diabetesglycemic control

Outcome Measures

Primary Outcomes (1)

  • Oral glucose tolerance test

    Measurement of blood glucose taken every 15 minutes over a course of three hours.

    3 weeks

Study Arms (1)

Alcohol consumption

EXPERIMENTAL

Alcohol consumption and wine consumption

Other: Alcohol consumption

Interventions

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

Alcohol consumption

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65202, United States

Location

Related 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. doi: 10.2337/diacare.27.6.1369.

    PMID: 15161790BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • John P Thyfault, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2012

First Posted

August 7, 2015

Study Start

March 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations