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:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT00539435
Eligibility Criteria:
Inclusion Criteria:
* The researchers will include up to 400 pts between male and female between the ages of 21 and 85 diagnosed with diabetes mellitus and cardiac disease
* Self reporting or diagnosed with significant complications resulting from diabetes
* Taking oral agents and/or insulin for diabetic control
* Under an Endocrinologist supervision for their diabetes management, Endocrinologist must assess and approve pt for participation in this study
* Ability to swallow without difficulty
* Ability to perform Respiratory Quotient requirements by breathing into a mask for 3 minutes at a time
Exclusion Criteria:
* Lack of Intravenous access
* Pregnancy
* Alcohol abuse, drug addiction or the use of illegal drugs
* Active liver disease
* Active chemotherapy
* Positive HIV
* Inability to breathe into a respiratory quotient machine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT00539435
Study Brief:
Protocol Section:
NCT00539435