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
  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:


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
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

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 Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
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 September 16, 2014