This trial is active, not recruiting.

Conditions diabetes, prediabetes
Treatment alcohol
Phase phase 3
Sponsor Ben-Gurion University of the Negev
Start date May 2010
End date May 2012
Trial size 200 participants
Trial identifier NCT00784433, SOR478108CTIL


Moderate alcohol may be beneficial for diabetics

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
150 cc
150 cc
(Placebo Comparator)
150 cc

Primary Outcomes

Glycemic control
time frame: 6 months

Secondary Outcomes

CVD status
time frame: 6 months

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

Inclusion Criteria: - Established diagnosis of type 2 diabetes - Male or female alcohol abstainers (not more than 1 drink/week) - Age between 40-75 yrs - Clinically stable, with no history of stroke or myocardial infarction or major surgery within the previous 3 months Exclusion Criteria: - The use of RI or short-acting analog insulin/ pump therapy. Patients on 1-2 injections per day of NPH or long-acting analogs will be eligible for inclusion - Triglycerides > 500 mg/dL - HbA1c<7 or > 10% - Serum creatinine > 2 mg/dl - Liver dysfunction (greater than 2-fold elevation of ALT or and 3-fold elevation of AST) - Evidence of severe diabetes complications (such as proliferative retinopathy or overt nephropathy) - Autonomic neuropathy manifested as postural hypotension or hypoglycemia unawareness - Patients with chronic hepatitis (C,B) - Use of drugs that might significantly interact with alcohol such as sedatives, antihistamines, and anti-coagulants - Presence of active cancer, or chemotherapy within the past 3 years - Major illness that may require hospitalization - A high potential of addictive behavior based on physician's assessment or personal or family history of addiction, alcoholism, or alcohol abuse - Pregnant or lactating woman - Participation in another trial with active intervention

Additional Information

Official title Cardiovascular and Metabolic Effects of Moderate Alcohol Consumption in Type 2 Diabetes
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by Ben-Gurion University of the Negev.