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Clinical Trials/NCT00784433
NCT00784433CompletedPhase 3

Cardiovascular and Metabolic Effects of Moderate Alcohol Consumption in Type 2 Diabetes

Ben-Gurion University of the Negev0 sites224 target enrollmentStarted: June 1, 2010Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
224
Primary Endpoint
Glycemic control
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Moderate alcohol may be beneficial for diabetics

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
40 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

alcohol 2

Experimental

Intervention: alcohol (Dietary Supplement)

alcohol 1

Experimental

Intervention: alcohol (Dietary Supplement)

control

Placebo Comparator

Intervention: alcohol (Dietary Supplement)

Outcomes

Primary Outcomes

Glycemic control

Time Frame: 6 months

Secondary Outcomes

  • CVD status(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Iris Shai

Iris Shai

Ben-Gurion University of the Negev

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