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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07371169
Eligibility Criteria:
Inclusion Criteria:
* Adolescent patients of both sexes, aged 12 to 18 years.
* Clinically diagnosed with acanthosis nigricans.
* Present Insulin resistance, defined as Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) ≥ 2.5.
* Willing to participate in the study, with written informed consent provided by both the patient and guardian.
Exclusion Criteria:
* Diagnosis of type 1 or type 2 diabetes mellitus.
* Known hypersensitivity to chromium or any of the capsule excipients.
* Use of insulin-sensitizing medications (e.g., metformin, thiazolidinediones) within 3 months before screening.
* Use of systemic corticosteroids or other medications known to affect glucose metabolism within 3 months before screening.
* Significant renal disease (estimated glomerular filtration rate \< 60 mL/min/1.73 m²) or liver disease (alanine aminotransferase or aspartate aminotransferase \> 2.5 times the upper limit of normal).
* Pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT07371169
Study Brief:
Protocol Section:
NCT07371169