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The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Ben-Gurion University of the Negev.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Iris Shai, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier:
NCT00784433
First received: November 3, 2008
Last updated: February 8, 2012
Last verified: August 2009
History of Changes
  Purpose

Moderate alcohol may be beneficial for diabetics


Condition Intervention Phase
Diabetes
Prediabetes
 Dietary Supplement: alcohol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cardiovascular and Metabolic Effects of Moderate Alcohol Consumption in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Glycemic control [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • CVD status [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Iris Shai, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT00784433     History of Changes
Other Study ID Numbers: SOR478108CTIL
Study First Received: November 3, 2008
Last Updated: February 8, 2012
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on June 18, 2013