Status:
COMPLETED
The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial
Lead Sponsor:
Ben-Gurion University of the Negev
Conditions:
Diabetes
Prediabetes
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
Moderate alcohol may be beneficial for diabetics
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00784433
Start Date
June 1 2010
End Date
May 1 2012
Last Update
July 15 2019
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