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Moderate Alcohol Intake Among Patients With Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by The S. Daniel Abraham International Center for Health and Nutrition.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The Israeli Diabetes Research Group
Itamar Raz, Hadassah Medical Center, Jerusalem, Israel
Soroka University Medical Center
Julio Vainstein, Wolfson Medical Center, Holon, Israel
Tishbi Wines, Israel and Admiral Wine Imports, US
Harvard University
Information provided by:
The S. Daniel Abraham International Center for Health and Nutrition
ClinicalTrials.gov Identifier:
NCT00295334
First received: February 21, 2006
Last updated: September 11, 2006
Last verified: September 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: alcohol
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The S. Daniel Abraham International Center for Health and Nutrition:

Primary Outcome Measures:
  • adherence, HbA1c, Glc

Secondary Outcome Measures:
  • LDL, HDL, TG

Estimated Enrollment: 100
Study Start Date: February 2006
Estimated Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295334

Sponsors and Collaborators
The S. Daniel Abraham International Center for Health and Nutrition
The Israeli Diabetes Research Group
Itamar Raz, Hadassah Medical Center, Jerusalem, Israel
Soroka University Medical Center
Julio Vainstein, Wolfson Medical Center, Holon, Israel
Tishbi Wines, Israel and Admiral Wine Imports, US
Harvard University
Investigators
Principal Investigator: Iris Shai, RD PhD Ben-Gurion University of the Negev
  More Information

No publications provided by The S. Daniel Abraham International Center for Health and Nutrition

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00295334     History of Changes
Other Study ID Numbers: 250505
Study First Received: February 21, 2006
Last Updated: September 11, 2006
Health Authority: Israel: Ethics Commission

Keywords provided by The S. Daniel Abraham International Center for Health and Nutrition:
adherence
glycemic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013