Diabetes Mellitus, Type 2WGCNCT02518334
Wine Consumption and Glycemic Control
A study testing Alcohol consumption in people with Diabetes Mellitus, Type 2, run by University of Missouri-Columbia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Alcohol consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Alcohol consumption
- Keywords
- type two diabetes, glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol consumptionOther
28 grams (2 drinks) of ethanol will be consumed either in the form of wine or vodka.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol consumption | Experimental | Alcohol consumption and wine consumption Receives: Other: Alcohol consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral glucose tolerance test
Measurement of blood glucose taken every 15 minutes over a course of three hours.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startMar 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John P Thyfault, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518334
- Sponsor's protocol ID
- Wine and GC
- Acronym
- WGC
- Status last verified
- Oct 2017
- First submitted
- 8 Feb 2012
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 15161790
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wine Consumption and Glycemic Control
- ClinicalTrials.gov ID
- NCT02518334
- Acronym / sponsor ID
- WGC / Wine and GC
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- type two diabetes, glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alcohol consumption | Experimental | Other: Alcohol consumptionAlcohol consumption and wine consumption |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol consumption28 grams (2 drinks) of ethanol will be consumed either in the form of wine or vodka. | Other | Alcohol consumption |
Primary outcome
Oral glucose tolerance test
Time frame: 3 weeks
Measurement of blood glucose taken every 15 minutes over a course of three hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Background: PubMed 15161790Avogaro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P Thyfault, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol consumption in people with Diabetes Mellitus, Type 2, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral glucose tolerance test (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02518334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.