Status:
COMPLETED
Moderate Alcohol Intake Among Patients With Type 2 Diabetes
Lead Sponsor:
Iris Shai
Collaborating Sponsors:
The Israeli Diabetes Research Group
Hadassah Medical Organization
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief 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.
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...
Eligibility Criteria
Inclusion
- Age between 40-75 yrs.
- Alcohol abstainers (less than or equal to 1 drink/week)
- Established diagnosis of type 2 diabetes.
- Clinically stable, with no stroke or MI within the last 3 months and no major surgery within the last 3 months.
Exclusion
- Taking Insulin \>2 injections /day, or with insulin pump.
- TGs\>500 mg/dL.
- HbA1c \>10%
- Serum creatinine \> 2 mg/dl
- 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.
- \-
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00295334
Start Date
June 1 2010
End Date
May 1 2012
Last Update
June 24 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.