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OpenTrials
Completed

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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Key information

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

Alcohol

Drug

Primary outcomes

  1. Glucose

    Time frame: Differance between 3 month time point minus baseline

    A change from baseline to 3-month time points is reported

  2. Adherence

    Time frame: Adherence at 3-months (end of intervention)

    Count of participants that finished the 3-month intervention

  3. HbA1c

    Time frame: Differance between 3 month time point minus baseline

    A change from baseline to 3-month time points is reported

Secondary outcomes

  1. 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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