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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT01413035
Eligibility Criteria:
Inclusion Criteria:
* Free will taking part in the study and ability to provide written informed consent
* Type 2 diabetes mellitus (as guideline WHO, 1999)
* Age 18-80 years old, Male/Female
* 19≤Body mass index (BMI)≤30㎏/㎡
* Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％
* Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance
* Not pregnant or nursing
* No moderate or sever organ dysfunction: Ejection fraction\>45%; Creatinine \<176 mmol/L
* No active severe viral or fungus infection
Exclusion Criteria:
* Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction)
* Active infection requiring treatment
* Unexplained febrile illness
* Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection
* Psychiatric condition that would limit informed consent
* Patient has enrolled another clinical trial study within last 4 weeks.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01413035
Study Brief:
Protocol Section:
NCT01413035