Efficacy of Chromium Picolinate in Reducing Acanthosis Nigricans Severity in Adolescents With Insulin Resistance

Uruk University

Status: Completed

Conditions: Insulin Resistance; Acanthosis Nigricans

Treatments: Drug: Placebo matching Chromium Picolinate; Drug: Chromium picolinate

Study type: Interventional

Funder types: Other

Identifiers

NCT07371169

UU-CR-2025-01

Details and patient eligibility

About

The goal of this clinical trial is to learn if chromium picolinate can reduce the severity of acanthosis nigricans and improve insulin resistance in adolescents with both conditions. It will also learn about the safety of chromium picolinate use in this age group. The main questions it aims to answer are:

1. Does chromium picolinate reduce the severity of acanthosis nigricans as measured by the Burke quantitative scale for acanthosis nigricans severity in adolescents with insulin resistance?
2. Does chromium picolinate improve insulin resistance as measured by the homeostasis model assessment of insulin resistance (HOMA-IR)?
3. What medical problems do participants have when taking chromium picolinate? Researchers will compare chromium picolinate to placebo to see if chromium picolinate is effective in reducing acanthosis nigricans severity and improving insulin resistance.

Participants will:

1. Take chromium picolinate or placebo daily for 24 weeks.
2. Acquire baseline assessment and then visit the clinic at 8 weeks, 16 weeks, and 24 weeks for clinical evaluation, acanthosis nigricans severity assessment using the Burke quantitative scale for acanthosis nigricans severity, laboratory assessment of insulin resistance using the homeostasis model assessment of insulin resistance, and monitoring for any side effects or complications.

Enrollment: 90 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Chromium Picolinate

Experimental group

Description:

Participants in this arm (n=45) will recieve oral Chromium Picolinate 200mcg capsules once daily during the 24-weeks study period.

Treatment:

Drug: Chromium picolinate

Placebo Control

Placebo Comparator group

Description:

Participants in this arm (n=45) will recieve oral placebo capsules matching the shape size and color of Chromium Picolinate, once daily during the 24-weeks study period; they will act as the control group.

Treatment:

Drug: Placebo matching Chromium Picolinate