The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-05-31

Brief Summary

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Moderate alcohol may be beneficial for diabetics

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Detailed Description

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Conditions

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Diabetes Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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alcohol 1

Group Type EXPERIMENTAL

alcohol

Intervention Type DIETARY_SUPPLEMENT

150 cc

alcohol 2

Group Type EXPERIMENTAL

alcohol

Intervention Type DIETARY_SUPPLEMENT

150 cc

control

Group Type PLACEBO_COMPARATOR

alcohol

Intervention Type DIETARY_SUPPLEMENT

150 cc

Interventions

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alcohol

150 cc

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No