NCT00295334

Brief Summary

Our specific aim is to explore the effect of moderate alcohol intake on parameters of glycemic index and lipid profile among patients with type 2 diabetes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes

Timeline
Completed

Started Jun 2010

Typical duration for phase_2 type-2-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

February 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2006

Completed
4.3 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
13.2 years until next milestone

Results Posted

Study results publicly available

June 24, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

1.9 years

First QC Date

February 21, 2006

Results QC Date

May 4, 2024

Last Update Submit

June 5, 2025

Conditions

Type 2 Diabetes

Keywords

adherenceglycemic control

Outcome Measures

Primary Outcomes (3)

  • Glucose

    A change from baseline to 3-month time points is reported

    Differance between 3 month time point minus baseline

  • Adherence

    Count of participants that finished the 3-month intervention

    Adherence at 3-months (end of intervention)

  • HbA1c

    A change from baseline to 3-month time points is reported

    Differance between 3 month time point minus baseline

Secondary Outcomes (1)

  • LDL, HDL, TG

    A change from baseline to 3-month time points is reported

Study Arms (3)

Mediterranean diet + red wine

ACTIVE COMPARATOR
Drug: alcohol

Mediterranean diet + white wine

ACTIVE COMPARATOR
Drug: alcohol

Mediterranean diet+ mineral water

PLACEBO COMPARATOR
Drug: alcohol

Interventions

alcoholDRUG
Mediterranean diet + red wineMediterranean diet + white wineMediterranean diet+ mineral water

Eligibility Criteria

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

You may qualify if:

  • Age between 40-75 yrs.
  • Alcohol abstainers (less than or equal to 1 drink/week)
  • Established diagnosis of type 2 diabetes.
  • Clinically stable, with no stroke or MI within the last 3 months and no major surgery within the last 3 months.

You may not qualify if:

  • Taking Insulin \>2 injections /day, or with insulin pump.
  • TGs\>500 mg/dL.
  • HbA1c \>10%
  • Serum creatinine \> 2 mg/dl
  • Liver dysfunction (above 2 fold level of ALT and/or AST enzymes)
  • \. Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).
  • \. Patients with autonomic neuropathy manifested as postural hypertension and/or hypoglycemia unawareness. 7. Using drugs that might significantly interact with moderate alcohol. List of drugs will be obtained from pharmacology expert. 8. Presence of active cancer, receiving or had received chemotherapy in last 3 years.
  • \. Suffering a major illness that might probably require hospitalization (upon physician's evaluation).
  • \. Clinically assessed as having high potential of addictive behavior as judged by a validated clinical assessment and/or personal or family history of addiction, alcoholism or alcohol abuse.
  • \. Severe symptoms during run-in as assessed by the physician. 12. Pregnant or lactating women. 13. Participation in another trial in which active intervention is being received.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shai I, Wainstein J, Harman-Boehm I, Raz I, Fraser D, Rudich A, Stampfer MJ. Glycemic effects of moderate alcohol intake among patients with type 2 diabetes: a multicenter, randomized, clinical intervention trial. Diabetes Care. 2007 Dec;30(12):3011-6. doi: 10.2337/dc07-1103. Epub 2007 Sep 11.

    PMID: 17848609DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Iris Shai
Organization
Ben-Gurion University of the Negev
irish@bgu.ac.il
+972086477443

Study Officials

  • Iris Shai, RD PhD

    Ben-Gurion University of the Negev

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 23, 2006

Study Start

June 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 24, 2025

Results First Posted

June 24, 2025

Record last verified: 2025-06