Efficacy of Chromium Picolinate in Reducing Acanthosis Nigricans Severity in Adolescents With Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in the clinical severity of Acanthosis Nigricans
研究概览
简要总结
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:
- 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?
- Does chromium picolinate improve insulin resistance as measured by the homeostasis model assessment of insulin resistance (HOMA-IR)?
- 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:
- Take chromium picolinate or placebo daily for 24 weeks.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This is a double-blind study. Participants, and outcome assessors, (Physician and laboratory personnel) will be unaware of treatment assignment. Clinical assessment of acanthosis nigricans severity using the Burke quantitative scale for acanthosis nigricans severity and laboratory assessment of insulin resistance using the homeostasis model assessment of insulin resistance, based on fasting plasma glucose and fasting serum insulin measurements, will be performed without knowledge of treatment allocation. The study medication and placebo will be identical in appearance and packaging. Treatment allocation codes will be securely stored and will be revealed only after completion of data analysis, unless unblinding is required for participant safety.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Willing to participate in the study, with written informed consent provided by both the patient and guardian.
排除标准
- •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.
研究组 & 干预措施
Chromium Picolinate
Participants in this arm (n=45) will recieve oral Chromium Picolinate 200mcg capsules once daily during the 24-weeks study period.
干预措施: Chromium picolinate (Drug)
Placebo Control
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.
干预措施: Placebo matching Chromium Picolinate (Drug)
结局指标
主要结局
Change in the clinical severity of Acanthosis Nigricans
时间窗: Baseline, 8 weeks, 16 weeks, 24 weeks from enrollment
Acanthosis nigricans clinical severity will be measured using Burke's quantitative scale by a trained physician. This scale involves the summation of five parameters representing the severity of Acanthosis Nigricans, which are Neck severity (0-4), Neck texture (0-3), axilla severity (0-4), elbows (0 if Absent, 1 if present), knuckles (0 if Absent, 1 if present), and knees (0 if Absent, 1 if present). The minimum score of this scale is 0, and the maximum is 14. The primary outcome is the difference in acanthosis nigricans severity between the chromium picolinate group and the placebo control group.
Change in the severity of insulin resistance
时间窗: Baseline, 8 weeks, 16 weeks, 24 weeks
The severity of insulin resistance will be measured using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), this involves taking a fasting blood sample to measure plasma glucose and serum insulin and applying the formula (HOMA-IR = (Fasting insulin \[µIU/mL\] × Fasting glucose \[mg/dL\]) / 405). The primary outcome is the difference in insulin resistance severity based on HOMA-IR results between the chromium picolinate group and the placebo control group.
次要结局
未报告次要终点
研究者
Ghasak kais Abdulhussain
Lecturer in department of Pharmacology (B.Sc , M.Sc, Ph.D) / College of Pharmacy
Uruk University