The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial

Overview

Moderate alcohol may be beneficial for diabetics

Full Title of Study: “Cardiovascular and Metabolic Effects of Moderate Alcohol Consumption in Type 2 Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2012

Interventions

  • Dietary Supplement: alcohol
    • 150 cc

Arms, Groups and Cohorts

  • Experimental: alcohol 1
  • Experimental: alcohol 2
  • Placebo Comparator: control

Clinical Trial Outcome Measures

Primary Measures

  • Glycemic control
    • Time Frame: 6 months

Secondary Measures

  • CVD status
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ben-Gurion University of the Negev
  • Provider of Information About this Clinical Study
    • Principal Investigator: Iris Shai, Iris Shai – Ben-Gurion University of the Negev

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