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Completed

NCT Number: NCT00784433

The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial

Moderate alcohol may be beneficial for diabetics

Completed

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases PreDiabetes Prediabetic State

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol

Dietary Supplement

150 cc

Primary outcomes

  1. Glycemic control

    Time frame: 6 months

Secondary outcomes

  1. CVD status

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ben-Gurion University of the Negev

Other

Registry information

Official study title

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

Acronym: CASCADE

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 4, 2008
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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