Moderate Alcohol Intake Among Patients With Type 2 Diabetes

Iris Shai

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: alcohol

Study type: Interventional

Funder types: Other

Identifiers

NCT00295334

250505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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)

6. Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).

7. 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.

8. Suffering a major illness that might probably require hospitalization (upon physician's evaluation).

9. 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.

10. 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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109 participants in 3 patient groups, including a placebo group

Mediterranean diet + red wine

Active Comparator group

Treatment:

Drug: alcohol

Mediterranean diet + white wine

Active Comparator group

Treatment:

Drug: alcohol

Mediterranean diet+ mineral water

Placebo Comparator group

Treatment:

Drug: alcohol