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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT04638556
Eligibility Criteria:
The normal group
Inclusion Criteria:
Healthy Volunteers
Exclusion Criteria:
Peripheral neuropathy
The T2DM group
Inclusion Criteria:
Patients who were diagnosed with type 2 diabetes in accordance with the Chinese guidelines for the prevention and treatment of type 2 diabetes (2017 Edition) Patients who decided to voluntarily participate in clinical trials and agreed in writing
Exclusion Criteria:
Patients with diabetic complication Patients with a systolic blood pressure(SBP)≥ 160 mmHg or ≤ 100 mmHg or a diastolic blood pressure(DBP) ≥ 95 mmHg or ≤ 60 mmHg Patients with other disease
The DPN group
Inclusion Criteria:
Patients who were diagnosed with type 2 diabetes in accordance with the Chinese guidelines for the prevention and treatment of type 2 diabetes (2017 Edition) Neuropathy at or after the diagnosis of diabetes Clinical symptoms include: numbness or sensation, tingling or tingling, pain, abnormal sensitivity or tenderness after touching
Examination item include:
1. abnormal temperature sense
2. 10 g nylon thread examination, foot sensation decreased or disappeared
3. abnormal vibration sense
4. ankle reflex disappeared
5. two or more items of nerve conduction velocity were slowed down (electromyography or sensory threshold measurement) Patients with two of the above five items were abnormal, or patients with clinical symptoms plus 1 item
Exclusion Criteria:
Nerve injury caused by other diseases or drugs Patients with T1DM or other endocrine system diseases, acute complications of diabetes, such as diabetic ketoacidosis and hypertonic non ketotic coma, cardiovascular and cerebrovascular diseases, nonalcoholic fatty liver disease, liver and kidney failure, inflammatory diseases, active infection, cancer, pregnancy or lactation Patients with a systolic blood pressure(SBP)≥ 160 mmHg or ≤ 100 mmHg or a diastolic blood pressure(DBP) ≥ 95 mmHg or ≤ 60 mmHg In addition to the above items, patients who are deemed inappropriate by clinical trial researchers
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04638556
Study Brief:
Protocol Section:
NCT04638556