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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT00728403
Eligibility Criteria:
Inclusion Criteria:
* presence of type 2 diabetes (at least 1 year) as defined by A1c between ≥6.5% and ≤8.1%, at recruitment,
* treatment with diet or oral hypoglycemic medication be unchanged starting at least 2 months prior to the beginning of the study (at recruitment, week -8)
* between the age of 40 and 75 years
* systolic blood pressure \<140 and diastolic blood pressure \<90
* clinically euthyroid (measuring T3 and T4)
* normal renal and liver functions
* post-menopausal or non-pregnant women (Post-menopausal includes: those females with more than a year of cessation of menstruation)
* a negative result on a pregnancy test administered at screening
* subjects taking an effective form of birth control (example: condom, abstinence, etc.)
* willing to comply with the study protocol and sign a consent form
Exclusion Criteria:
* individuals with bleeding disorders
* individuals with allergies to nitroglycerin
* planned surgery, pregnancy or breastfeeding
* taking insulin; clinically significant diabetes complications (retinopathy, nephropathy, or neuropathy); serum triglycerides ≥ 4.5 mmol/L
* increased A1c level of more than 2% from baseline during the study
* history of angina or heart attack
* use of ginseng or any natural health products with glucose modulating and/or anti-platelet activity within 2 months
* BMI \> 35 kg/m2 including a weight fluctuation of + 2kg during treatment periods
* smoke cigarettes; alcohol intake \> 2 drinks/day
* the presence of any conditions which, in the opinion of the investigator, might jeopardize the health and safety of the subject or study personnel or adversely affect the study results, if the subject participated in the study
* Subjects taking Warfarin or Coumadin, prescription NSAIDs, chronic use of high-dose (\>81mg) non-prescription NSAIDs, or selective serotonin reuptake inhibitors and monoamine oxidase inhibitors, or sympathomimetics or medications affecting nitric oxide levels, or any known or suspected sensitivity to any of the ingredients in the test product or placebo cannot participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00728403
Study Brief:
Protocol Section:
NCT00728403