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The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial (CASCADE)

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ClinicalTrials.gov Identifier: NCT00784433
Recruitment Status : Unknown
Verified August 2009 by Iris Shai, Ben-Gurion University of the Negev.
Recruitment status was:  Active, not recruiting
First Posted : November 4, 2008
Last Update Posted : February 9, 2012
Information provided by (Responsible Party):
Iris Shai, Ben-Gurion University of the Negev

Brief Summary:
Moderate alcohol may be beneficial for diabetics

Condition or disease Intervention/treatment Phase
Diabetes Prediabetes Dietary Supplement: alcohol Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cardiovascular and Metabolic Effects of Moderate Alcohol Consumption in Type 2 Diabetes
Study Start Date : May 2010
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: alcohol 1 Dietary Supplement: alcohol
150 cc
Experimental: alcohol 2 Dietary Supplement: alcohol
150 cc
Placebo Comparator: control Dietary Supplement: alcohol
150 cc

Primary Outcome Measures :
  1. Glycemic control [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. CVD status [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Iris Shai, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT00784433     History of Changes
Other Study ID Numbers: SOR478108CTIL
First Posted: November 4, 2008    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: August 2009

Keywords provided by Iris Shai, Ben-Gurion University of the Negev:
alcohol diabetes CVD

Additional relevant MeSH terms:
Diabetes Mellitus
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs