search
Back to results

Moderate Alcohol Intake Among Patients With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
alcohol
Sponsored by
The S. Daniel Abraham International Center for Health and Nutrition
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring adherence, glycemic control

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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) 5. Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease). 6. 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. 9. Suffering a major illness that might probably require hospitalization (upon physician's evaluation). 10. 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. 11. 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. -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    adherence, HbA1c, Glc

    Secondary Outcome Measures

    LDL, HDL, TG

    Full Information

    First Posted
    February 21, 2006
    Last Updated
    September 11, 2006
    Sponsor
    The S. Daniel Abraham International Center for Health and Nutrition
    Collaborators
    The Israeli Diabetes Research Group, Hadassah Medical Organization, Soroka University Medical Center, Julio Vainstein, Wolfson Medical Center, Holon, Israel, Tishbi Wines, Israel and Admiral Wine Imports, US, Harvard University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00295334
    Brief Title
    Moderate Alcohol Intake Among Patients With Type 2 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2006
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    The S. Daniel Abraham International Center for Health and Nutrition
    Collaborators
    The Israeli Diabetes Research Group, Hadassah Medical Organization, Soroka University Medical Center, Julio Vainstein, Wolfson Medical Center, Holon, Israel, Tishbi Wines, Israel and Admiral Wine Imports, US, Harvard University

    4. Oversight

    5. Study Description

    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.
    Detailed Description
    Successful long-term control of hyperglycemia decreases the risk for diabetic complications . Although a family history of diabetes is an established risk factor for type 2 diabetes, lifestyle factors also play an important role in its cause . However, physicians are poorly informed about how their patients' alcohol use affects risk for or management of diabetes. Moderate alcohol consumption has been associated with lower risk of both cardiovascular disease and type 2 diabetes, and is also linked to lower cardiovascular risk among type 2 diabetics. Potential mechanisms have focused primarily on lipid metabolism, coagulation, fibrinolysis, and insulin sensitivity. A recent systematic review of the literature to assess the effect of alcohol consumption on risk for and management and complications of diabetes mellitus suggests that moderate alcohol consumption is associated with a decreased risk for diabetes, whereas heavy alcohol consumption may be associated with an increased risk. Our aim is to assess the effect of moderate alcohol intake on glycemic control and cardiovascular disease mediators among patients with type 2 diabetes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes
    Keywords
    adherence, glycemic control

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    100 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    alcohol
    Primary Outcome Measure Information:
    Title
    adherence, HbA1c, Glc
    Secondary Outcome Measure Information:
    Title
    LDL, HDL, TG

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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) 5. Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease). 6. 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. 9. Suffering a major illness that might probably require hospitalization (upon physician's evaluation). 10. 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. 11. 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. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Iris Shai, RD PhD
    Organizational Affiliation
    Ben-Gurion University of the Negev
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17848609
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Moderate Alcohol Intake Among Patients With Type 2 Diabetes

    We'll reach out to this number within 24 hrs