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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT00784433
Eligibility Criteria:
Inclusion Criteria:
* Established diagnosis of type 2 diabetes
* Male or female alcohol abstainers (not more than 1 drink/week)
* Age between 40-75 yrs
* Clinically stable, with no history of stroke or myocardial infarction or major surgery within the previous 3 months
Exclusion Criteria:
* The use of RI or short-acting analog insulin/ pump therapy. Patients on 1-2 injections per day of NPH or long-acting analogs will be eligible for inclusion
* Triglycerides \> 500 mg/dL
* HbA1c\<7 or \> 10%
* Serum creatinine \> 2 mg/dl
* Liver dysfunction (greater than 2-fold elevation of ALT or and 3-fold elevation of AST)
* Evidence of severe diabetes complications (such as proliferative retinopathy or overt nephropathy)
* Autonomic neuropathy manifested as postural hypotension or hypoglycemia unawareness
* Patients with chronic hepatitis (C,B)
* Use of drugs that might significantly interact with alcohol such as sedatives, antihistamines, and anti-coagulants
* Presence of active cancer, or chemotherapy within the past 3 years
* Major illness that may require hospitalization
* A high potential of addictive behavior based on physician's assessment or personal or family history of addiction, alcoholism, or alcohol abuse
* Pregnant or lactating woman
* Participation in another trial with active intervention
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00784433
Study Brief:
Protocol Section:
NCT00784433