Intervention Study of Alcohol, Cardiovascular Disease (CVD) and Diabetes - Full Text View

Intervention Study of Alcohol, Cardiovascular Disease (CVD) and Diabetes (ACDC)

This study is not yet open for participant recruitment.

Verified by Ben-Gurion University of the Negev, November 2008

Sponsored by:	Ben-Gurion University of the Negev
Information provided by:	Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier:	NCT00784433

Purpose

Moderate alcohol may be beneficial for diabetics

Condition	Intervention	Phase
Diabetes Prediabetes	Dietary Supplement: alcohol	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Ethanol

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Cardiovascular and Metabolic Effects of Moderate Alcohol Consumption in Type 2 Diabetes

Further study details as provided by Ben-Gurion University of the Negev:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	200
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
alcohol 1: Experimental	Dietary Supplement: alcohol 150 cc
alcohol 2: Experimental	Dietary Supplement: alcohol 150 cc
control: Placebo Comparator	Dietary Supplement: alcohol 150 cc

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784433

Contacts

Contact: Iris Shai, PhD

972-8-6477443

Sponsors and Collaborators

Ben-Gurion University of the Negev

More Information

Responsible Party:	Ben Gurion University ( Iris Shai )
Study ID Numbers:	SOR478108CTIL
Study First Received:	November 3, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00784433
Health Authority:	Israel: Ministry of Health

Keywords provided by Ben-Gurion University of the Negev:

alcohol diabetes CVD

Study placed in the following topic categories:

Hyperglycemia
Metabolic Diseases
Glucose Intolerance
Diabetes Mellitus, Type 2
Prediabetic State
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Alcohol Drinking
Ethanol

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Therapeutic Uses
Physiological Effects of Drugs

Central Nervous System Depressants
Cardiovascular Diseases
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009