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 @ 4:43 AM
Ignite Modification Date:
2025-12-25 @ 4:43 AM
NCT ID:
NCT01094418
Eligibility Criteria:
Inclusion Criteria:
* For the normal healthy control group
* Healthy participants with normal NCS parameters
* For the IGT group
* Men or women aged 20-70 with IGT referred by the department of endocrinology, with FBS 100-126 mg/dl, post 2 hour OTT - 140-200mg/dl,lasting more than one year.
* Patients willing to undergo NCS.
* For the DM group
* Men or women aged 20-70 with DM type II patients referred by the department of endocrinology, with no previous diagnosis of peripheral polyneuropathy and who showed SNAP amplitudes of the sural and superficial peroneal nerves above 10mA.
* Patients willing to undergo NCS.
Exclusion Criteria:
* No previous diagnosis of any systemic condition related to peripheral polyneuropathy (malnutrition, alcoholic hepatitis, diabetes mellitus( normal group)), no previous medication history, such as chemotherapeutics
* No symptom or sign of peripheral polyneuropathy, no history of tingling sensation, muscle weakness, or gait disturbance
* Skin lesion or swelling that would interfere with NCS conduction
* Previous diagnosis or clinical symptoms that would indicate the presence of mononeuropathy or entrapment neuropathy of the lower extremity.
* Previous trauma episode of the lower extremity
* History of alcohol ( exceeding alcohol consumption of 170g per week ) or substance abuse,
* Pregnancy
* DM group
* Presence of undiagnosed peripheral polyneuropathy determined by screening of the sural and superficial peroneal nerves.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT01094418
Study Brief:
Protocol Section:
NCT01094418