Moderate Alcohol Intake Among Patients With Type 2 Diabetes

A Phase 2 study testing alcohol in people with Type 2 Diabetes, run by Iris Shai.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Our specific aim is to explore the effect of moderate alcohol intake on parameters of glycemic index and lipid profile among patients with type 2 diabetes. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: alcohol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 109 participants
Where: No sites listed yet
Study dates: Jun 2010to May 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age between 40-75 yrs.
Alcohol abstainers (less than or equal to 1 drink/week)
Established diagnosis of type 2 diabetes.
Clinically stable, with no stroke or MI within the last 3 months and no major surgery within the last 3 months.

Who cannot join

Taking Insulin >2 injections /day, or with insulin pump.
TGs>500 mg/dL.
HbA1c >10%
Serum creatinine > 2 mg/dl
Liver dysfunction (above 2 fold level of ALT and/or AST enzymes)
5. Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).

Show all 11Show fewer

6. Patients with autonomic neuropathy manifested as postural hypertension and/or hypoglycemia unawareness. 7. Using drugs that might significantly interact with moderate alcohol. List of drugs will be obtained from pharmacology expert. 8. Presence of active cancer, receiving or had received chemotherapy in last 3 years.
9. Suffering a major illness that might probably require hospitalization (upon physician's evaluation).
10. Clinically assessed as having high potential of addictive behavior as judged by a validated clinical assessment and/or personal or family history of addiction, alcoholism or alcohol abuse.
11. Severe symptoms during run-in as assessed by the physician. 12. Pregnant or lactating women. 13. Participation in another trial in which active intervention is being received.
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About this study

Our specific aim is to explore the effect of moderate alcohol intake on parameters of glycemic index and lipid profile among patients with type 2 diabetes.

Read the detailed description

Successful long-term control of hyperglycemia decreases the risk for diabetic complications . Although a family history of diabetes is an established risk factor for type 2 diabetes, lifestyle factors also play an important role in its cause . However, physicians are poorly informed about how their patients' alcohol use affects risk for or management of diabetes. Moderate alcohol consumption has been associated with lower risk of both cardiovascular disease and type 2 diabetes, and is also linked to lower cardiovascular risk among type 2 diabetics. Potential mechanisms have focused primarily on lipid metabolism, coagulation, fibrinolysis, and insulin sensitivity. A recent systematic review of the literature to assess the effect of alcohol consumption on risk for and management and complications of diabetes mellitus suggests that moderate alcohol consumption is associated with a decreased risk for diabetes, whereas heavy alcohol consumption may be associated with an increased risk. Our aim is to assess the effect of moderate alcohol intake on glycemic control and cardiovascular disease mediators among patients with type 2 diabetes.

Conditions: Type 2 Diabetes
Being tested: alcohol
Keywords: adherence, 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.

alcoholDrug

Study groups in NCT00295334
Study group	Role	What they receive
Mediterranean diet + red wine	Active comparator	Not described Receives: Drug: alcohol
Mediterranean diet + white wine	Active comparator	Not described Receives: Drug: alcohol
Mediterranean diet+ mineral water	Placebo comparator	Not described Receives: Drug: alcohol

What is being measured

The primary outcome is the main question the study is designed to answer.

Glucose
A change from baseline to 3-month time points is reported
Measured: Differance between 3 month time point minus baseline
Adherence
Count of participants that finished the 3-month intervention
Measured: Adherence at 3-months (end of intervention)
HbA1c
A change from baseline to 3-month time points is reported
Measured: Differance between 3 month time point minus baseline

Secondary outcomes (1)

LDL, HDL, TG
Differance between 3 month time point minus baseline
Measured: A change from baseline to 3-month time points is reported

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010May 2012

First posted23 Feb 2006 (estimated)
Study startJun 2010
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00295334
Sponsor's protocol ID: 250505
Status last verified: Jun 2025
First submitted: 21 Feb 2006
Last updated: 24 Jun 2025
Results posted: Yes, on ClinicalTrials.gov

Publications

Shai I, Wainstein J, Harman-Boehm I, Raz I, Fraser D, Rudich A, Stampfer MJ. Glycemic effects of moderate alcohol intake among patients with type 2 diabetes: a multicenter, randomized, clinical intervention trial. Diabetes Care. 2007 Dec;30(12):3011-6. doi: 10.2337/dc07-1103. Epub 2007 Sep 11.
PubMed 17848609

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Moderate Alcohol Intake Among Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00295334
Acronym / sponsor ID: 250505
Conditions: Type 2 Diabetes
Keywords: adherence, glycemic control
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Iris ShaiUniversity, hospital or other
Collaborators: The Israeli Diabetes Research Group, Hadassah Medical Organization, Soroka University Medical Center, Julio Vainstein, Wolfson Medical Center, Holon, Israel, Tishbi Wines, Israel and Admiral Wine Imports, US, Harvard University
Study start: Jun 2010
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 23 Feb 2006 (estimated)
Results: Posted 24 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Our specific aim is to explore the effect of moderate alcohol intake on parameters of glycemic index and lipid profile among patients with type 2 diabetes.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Number of arms: 3

Arm	Type	Receives
Mediterranean diet + red wine	Active comparator	Drug: alcohol
Mediterranean diet + white wine	Active comparator	Drug: alcohol
Mediterranean diet+ mineral water	Placebo comparator	Drug: alcohol

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age between 40-75 yrs.
Alcohol abstainers (less than or equal to 1 drink/week)
Established diagnosis of type 2 diabetes.
Clinically stable, with no stroke or MI within the last 3 months and no major surgery within the last 3 months.

Key exclusion criteria (11 listed)

Taking Insulin >2 injections /day, or with insulin pump.
TGs>500 mg/dL.
HbA1c >10%
Serum creatinine > 2 mg/dl
Liver dysfunction (above 2 fold level of ALT and/or AST enzymes)

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	Drug	Mediterranean diet + red wine, Mediterranean diet + white wine, Mediterranean diet+ mineral water

Primary outcome

Glucose
Time frame: Differance between 3 month time point minus baseline
A change from baseline to 3-month time points is reported
Adherence
Time frame: Adherence at 3-months (end of intervention)
Count of participants that finished the 3-month intervention
HbA1c
Time frame: Differance between 3 month time point minus baseline
A change from baseline to 3-month time points is reported

1 secondary outcome

LDL, HDL, TG
Time frame: A change from baseline to 3-month time points is reported

Results and safety

Results posted to the registry on 24 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	34	25
Alcohol	75	66

Primary outcome: Glucose

Time frame: Differance between 3 month time point minus baseline. Mean (Standard Deviation). Unit: mg/dL

Measure	Alcohol n = 75	Control n = 34
Value	-21.55 (41.18)	1.92 (25.69)

Primary outcome: Adherence

Time frame: Adherence at 3-months (end of intervention). Count of participants. Unit: Participants

Measure	Alcohol n = 75	Control n = 34
Value	66	25

Primary outcome: HbA1c

Time frame: Differance between 3 month time point minus baseline. Mean (Standard Deviation). Unit: % of HbA1c

Measure	Alcohol n = 75	Control n = 34
Value	-0.29 (0.99)	-0.24 (0.86)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alcohol	0 of 75 (0%)	3 of 75 (4%)	Not reported
Control	0 of 34 (0%)	1 of 34 (2.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 17848609Shai I, Wainstein J, Harman-Boehm I, Raz I, Fraser D, Rudich A, Stampfer MJ. Glycemic effects of moderate alcohol intake among patients with type 2 diabetes: a multicenter, randomized, clinical intervention trial. Diabetes Care. 2007 Dec;30(12):3011-6. doi: 10.2337/dc07-1103. Epub 2007 Sep 11.
Related InfoLink provided by the sponsor.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

Iris Shai, RD PhD principal investigator

Ben-Gurion University of the Negev

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing alcohol in people with Type 2 Diabetes, run by Iris Shai.

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 11 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Glucose (time frame: Differance between 3 month time point minus baseline). The study lists 3 primary outcomes in all. 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 NCT00295334, 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 24 Jun 2025.