Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT00295334
Eligibility 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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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00295334
Study Brief:
Protocol Section:
NCT00295334