NCT Number: NCT00295334
Moderate Alcohol Intake Among Patients With Type 2 Diabetes
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.
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Notify MeKey information
Conditions
Age range
40 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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)
- Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).
- 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.
- Suffering a major illness that might probably require hospitalization (upon physician's evaluation).
- 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.
- 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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Treatment and study plan
Primary outcomes
-
Glucose
Time frame: Differance between 3 month time point minus baseline
A change from baseline to 3-month time points is reported
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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
Secondary outcomes
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LDL, HDL, TG
Time frame: A change from baseline to 3-month time points is reported
Differance between 3 month time point minus baseline
Sponsors and collaborators
Lead sponsor
Iris Shai
Other
Collaborators
- Hadassah Medical Organization
- Harvard University
- Julio Vainstein, Wolfson Medical Center, Holon, Israel
- Soroka University Medical Center
- The Israeli Diabetes Research Group
- Tishbi Wines, Israel and Admiral Wine Imports, US
Registry information
Important dates
- Study start
- 2010
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Feb 23, 2006
- Registry last updated
- Jun 24, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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