The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial

Ben-Gurion University of the Negev

Status and phase

Completed

Phase 3

Conditions

Prediabetes

Diabetes

Treatments

Dietary Supplement: alcohol

Study type

Interventional

Funder types

Other

Identifiers

SOR478108CTIL

Details and patient eligibility

About

Moderate alcohol may be beneficial for diabetics

Enrollment

224 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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