Clinical trial NCT00784433: The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial
Official title: Cardiovascular and Metabolic Effects of Moderate Alcohol Consumption in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Prediabetes
Keywords: alcohol diabetes CVD
Lead sponsor: Ben-Gurion University of the Negev
Sponsor class: OTHER
First posted: 2008-11-04
Enrollment: 224
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Moderate alcohol may be beneficial for diabetics


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

Primary outcomes:
measure: Glycemic control
timeFrame: 6 months
Secondary outcomes:
measure: CVD status
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Golan R, Shelef I, Shemesh E, Henkin Y, Schwarzfuchs D, Gepner Y, Harman-Boehm I, Witkow S, Friger M, Chassidim Y, Liberty IF, Sarusi B, Serfaty D, Bril N, Rein M, Cohen N, Ben-Avraham S, Ceglarek U, Stumvoll M, Bluher M, Thiery J, Stampfer MJ, Rudich A, Shai I. Effects of initiating moderate wine intake on abdominal adipose tissue in adults with type 2 diabetes: a 2-year randomized controlled trial. Public Health Nutr. 2017 Feb;20(3):549-555. doi: 10.1017/S1368980016002597. Epub 2016 Oct 3.
citation: Gepner Y, Golan R, Harman-Boehm I, Henkin Y, Schwarzfuchs D, Shelef I, Durst R, Kovsan J, Bolotin A, Leitersdorf E, Shpitzen S, Balag S, Shemesh E, Witkow S, Tangi-Rosental O, Chassidim Y, Liberty IF, Sarusi B, Ben-Avraham S, Helander A, Ceglarek U, Stumvoll M, Bluher M, Thiery J, Rudich A, Stampfer MJ, Shai I. Effects of Initiating Moderate Alcohol Intake on Cardiometabolic Risk in Adults With Type 2 Diabetes: A 2-Year Randomized, Controlled Trial. Ann Intern Med. 2015 Oct 20;163(8):569-79. doi: 10.7326/M14-1650. Epub 2015 Oct 13.
citation: Gepner Y, Henkin Y, Schwarzfuchs D, Golan R, Durst R, Shelef I, Harman-Boehm I, Spitzen S, Witkow S, Novack L, Friger M, Tangi-Rosental O, Sefarty D, Bril N, Rein M, Cohen N, Chassidim Y, Sarusi B, Wolak T, Stampfer MJ, Rudich A, Shai I. Differential Effect of Initiating Moderate Red Wine Consumption on 24-h Blood Pressure by Alcohol Dehydrogenase Genotypes: Randomized Trial in Type 2 Diabetes. Am J Hypertens. 2016 Apr;29(4):476-83. doi: 10.1093/ajh/hpv126. Epub 2015 Aug 1.