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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT07148804
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of Type 1 or Type 2 diabetes mellitus
* Age between 15 and 65 years
* Diabetes duration of 1-5 years
* Body Mass Index (BMI) \< 30 kg/m²
* HbA1c \< 9%
* Serum creatinine \< 2mg/dL
* Serum α-amylase \< 45 IU/L (reference range: 28-100 IU/L)
* Vibration Perception Threshold (VPT) \> 15V
* Absence of clinical symptoms of diabetic polyneuropathy
Exclusion Criteria:
* Treatment with medications that might influence nerve function (antiepileptic agents, tricyclic antidepressants, sympathomimetic agents)
* Presence of myopathies
* Presence of neuropathies from other causes
* Presence of malignancies
* Clinical symptoms of diabetic polyneuropathy
* Inability to comply with study protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
65 Years
Study:
NCT07148804
Study Brief:
Protocol Section:
NCT07148804