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Moderate Alcohol Intake Among Patients With Type 2 Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by The S. Daniel Abraham International Center for Health and Nutrition.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00295334
First Posted: February 23, 2006
Last Update Posted: September 13, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00295334     History of Changes
Other Study ID Numbers: 250505
First Submitted: February 21, 2006
First Posted: February 23, 2006
Last Update Posted: September 13, 2006
Last Verified: September 2006

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs