Moderate Alcohol Intake Among Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00295334
• Other study ID #: 250505
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 21, 2006
• Last updated: September 11, 2006
• Start date: February 2006
• Est. completion date: December 2006

Study information

• Verified date: September 2006
• Source: The S. Daniel Abraham International Center for Health and Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• alcohol

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
The S. Daniel Abraham International Center for Health and Nutrition	Harvard University, Itamar Raz, Hadassah Medical Center, Jerusalem, Israel, Julio Vainstein, Wolfson Medical Center, Holon, Israel, Soroka University Medical Center, The Israeli Diabetes Research Group, Tishbi Wines, Israel and Admiral Wine Imports, US

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence, HbA1c, Glc
Secondary	LDL, HDL, TG