The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial

Phase 3

Completed

• Conditions: Diabetes; Prediabetes
• Interventions: Dietary Supplement: alcohol

• Registration Number: NCT00784433
• Lead Sponsor: Ben-Gurion University of the Negev

Brief Summary

Moderate alcohol may be beneficial for diabetics

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-03
• Study First Posted: 2008-11-04
• Status Verified: 2009-08
• Study Start: 2010-06
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alcohol 1	alcohol	-
alcohol 2	alcohol	-
control	alcohol	-

Primary Outcome Measures

Name	Time	Method
Glycemic control	6 months

Secondary Outcome Measures

Name	Time	Method
CVD status	6 months