Moderate Alcohol Intake Among Patients With Type 2 Diabetes

September 11, 2006 updated by: The S. Daniel Abraham International Center for Health and Nutrition
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Taking Insulin >2 injections /day, or with insulin pump.
  2. TGs>500 mg/dL.
  3. HbA1c >10%
  4. Serum creatinine > 2 mg/dl
  5. 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.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
adherence, HbA1c, Glc

Secondary Outcome Measures

Outcome Measure
LDL, HDL, TG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The S. Daniel Abraham International Center for Health and Nutrition

Collaborators

Hadassah Medical Organization
Harvard University
Soroka University Medical Center
The Israeli Diabetes Research Group
Julio Vainstein, Wolfson Medical Center, Holon, Israel
Tishbi Wines, Israel and Admiral Wine Imports, US

Investigators

  • Principal Investigator: Iris Shai, RD PhD, Ben-Gurion University of the Negev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

February 21, 2006

First Submitted That Met QC Criteria

February 21, 2006

First Posted (Estimate)

February 23, 2006

Study Record Updates

Last Update Posted (Estimate)

September 13, 2006

Last Update Submitted That Met QC Criteria

September 11, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 250505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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