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

July 11, 2019 updated by: Iris Shai, Ben-Gurion University of the Negev

Cardiovascular and Metabolic Effects of Moderate Alcohol Consumption in Type 2 Diabetes

Moderate alcohol may be beneficial for diabetics

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control
Dietary supplement: alcohol
150 cc
Experimental: alcohol 1
Dietary supplement: alcohol
150 cc
Experimental: alcohol 2
Dietary supplement: alcohol
150 cc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycemic control
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
CVD status
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ben-Gurion University of the Negev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

November 3, 2008

First Submitted That Met QC Criteria

November 3, 2008

First Posted (Estimate)

November 4, 2008

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOR478108CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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