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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
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 Identifier (NCT Number):

Responsible Party: Iris Shai, Ben-Gurion University of the Negev 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