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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Iris Shai, Ben-Gurion University of the Negev.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Iris Shai, Ben-Gurion University of the Negev Identifier:
First received: November 3, 2008
Last updated: February 8, 2012
Last verified: August 2009
Moderate alcohol may be beneficial for diabetics

Condition Intervention Phase
Diabetes Prediabetes Dietary Supplement: alcohol Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Iris Shai, Ben-Gurion University of the Negev:

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

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

Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alcohol 1 Dietary Supplement: alcohol
150 cc
Experimental: alcohol 2 Dietary Supplement: alcohol
150 cc
Placebo Comparator: control Dietary Supplement: alcohol
150 cc


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
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

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
Study First Received: November 3, 2008
Last Updated: February 8, 2012

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 processed this record on September 21, 2017