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CompletedNCT00784433CASCADEUpdated Jul 15, 2019

The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial

A Phase 3 interventional study of alcohol in Diabetes and Prediabetes, sponsored by Ben-Gurion University of the Negev. Completed. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-07-15.

Sponsored by Ben-Gurion University of the Negev · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

Moderate alcohol may be beneficial for diabetics

02

Conditions studied

  • Diabetes
  • Prediabetes

Keywords

  • alcohol diabetes CVD
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 224 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Ben-Gurion University of the Negev is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
224 participants (actual)

Study arms

  • Experimental
    alcohol 1

    Dietary Supplement: alcohol

  • Experimental
    alcohol 2

    Dietary Supplement: alcohol

  • Placebo comparator
    control

    Dietary Supplement: alcohol

Interventions

06

What researchers measure

Primary outcomes

  1. Glycemic control

    Time frame: 6 months

Secondary outcomes

  1. CVD status

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 27692023 ↗
  • 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. PubMed 26458258 ↗
  • 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. PubMed 26232779 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00784433
Lead sponsor
Ben-Gurion University of the Negev
Responsible party
Iris Shai (Iris Shai, Ben-Gurion University of the Negev) — Principal investigator
First posted
Nov 4, 2008
Start date
Jun 2010
Primary completion
May 2012
Completion
May 2012
Last update
Jul 15, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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