The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial

Diabetes Clinical Trial

— CASCADE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784433
• Other study ID #: SOR478108CTIL
• Status: Completed
• Phase: Phase 3
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: August 2009
• Source: Ben-Gurion University of the Negev
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Moderate alcohol may be beneficial for diabetics

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Prediabetes
• Prediabetic State

Intervention

Dietary Supplement:
• alcohol
150 cc

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ben-Gurion University of the Negev

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control		6 months
Secondary	CVD status		6 months