NCT00784433

Brief Summary

Moderate alcohol may be beneficial for diabetics

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline
Completed

Started Jun 2010

Typical duration for phase_3 diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2008

Completed
1.6 years until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 15, 2019

Status Verified

August 1, 2009

Enrollment Period

1.9 years

First QC Date

November 3, 2008

Last Update Submit

July 11, 2019

Conditions

DiabetesPrediabetes

Keywords

alcohol diabetes CVD

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

    6 months

Secondary Outcomes (1)

  • CVD status

    6 months

Study Arms (3)

alcohol 1

EXPERIMENTAL
Dietary Supplement: alcohol

alcohol 2

EXPERIMENTAL
Dietary Supplement: alcohol

control

PLACEBO COMPARATOR
Dietary Supplement: alcohol

Interventions

alcoholDIETARY_SUPPLEMENT

150 cc

alcohol 1alcohol 2control

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 27692023DERIVED

  • 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.

    PMID: 26458258DERIVED

  • 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.

    PMID: 26232779DERIVED

MeSH Terms

Conditions

Diabetes MellitusPrediabetic State

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Iris Shai

Study Record Dates

First Submitted

November 3, 2008

First Posted

November 4, 2008

Study Start

June 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

July 15, 2019

Record last verified: 2009-08