Insulin ResistanceNCT07371169
Efficacy of Chromium Picolinate in Reducing Acanthosis Nigricans Severity in Adolescents With Insulin Resistance
A study testing Chromium picolinate in people with Insulin Resistance and Acanthosis Nigricans, run by Uruk University at 1 site in Iraq.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Insulin Resistance, Acanthosis Nigricans
- What is being tested?
- Chromium picolinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Iraq1 site
Baghdad Medical City / Children Welfare Teaching Hospital / Department of Endocrinology
Baghdad, Baghdad Governorate, 10045
About this study
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.
Read more
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.
- Conditions
- Insulin Resistance, Acanthosis Nigricans
- Being tested
- Chromium picolinate, Placebo matching Chromium Picolinate
- Keywords
- Chromium Picolinate, Insulin resistance, Acanthosis Nigricans
- Medical subject headings
- Insulin Resistance, Acanthosis Nigricans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromium picolinateDrug
Chromium Picolinate Cap. 200mcg once daily for 24-weeks.
Placebo matching Chromium PicolinateDrug
An inert capsule identical in appearance and packaging to the chromium picolinate 200 microgram capsule (same size, shape, color, weight, and dosing schedule), manufactured without active ingredient. The capsule shell is composed of gelatin or hypromellose, matching the active capsules. The capsule is filled with inert excipients suitable for oral capsules, such as microcrystalline cellulose and magnesium stearate, to replicate the weight and flow properties of the active capsules. Optional coloring agents are included as needed to match the active product. Capsules are packaged in sealed blisters to minimize odor, taste, and visual cues. Dispensed by the investigational pharmacy according to the randomization schedule; to be taken once daily.
| Study group | Role | What they receive |
|---|---|---|
| Chromium Picolinate | Experimental | Participants in this arm (n=45) will recieve oral Chromium Picolinate 200mcg capsules once daily during the 24-weeks study period. Receives: Drug: Chromium picolinate |
| Placebo Control | Placebo comparator | 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. Receives: Drug: Placebo matching Chromium Picolinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the clinical severity of Acanthosis Nigricans
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.
Measured: Baseline, 8 weeks, 16 weeks, 24 weeks from enrollment
Change in the severity of insulin resistance
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.
Measured: Baseline, 8 weeks, 16 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Jan 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uruk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghasak kais Abdulhussain, Uruk University
- Investigators
- Ghasak Kais Abdulhussain, BSc, MSc, PhD (Pharmacology), Principal investigator, Uruk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371169
- Sponsor's protocol ID
- UU-CR-2025-01
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data, including acanthosis nigricans severity measurements, insulin resistance severity status, baseline demographics, and follow-up data relevant to primary outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chromium Picolinate in Reducing Acanthosis Nigricans Severity in Adolescents With Insulin Resistance
- ClinicalTrials.gov ID
- NCT07371169
- Acronym / sponsor ID
- UU-CR-2025-01
- Conditions
- Insulin Resistance, Acanthosis Nigricans
- Keywords
- Chromium Picolinate, Insulin resistance, Acanthosis Nigricans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Uruk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chromium Picolinate | Experimental | Drug: Chromium picolinateParticipants in this arm (n=45) will recieve oral Chromium Picolinate 200mcg capsules once daily during the 24-weeks study period. |
| Placebo Control | Placebo comparator | Drug: Placebo matching Chromium PicolinateParticipants 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chromium picolinateChromium Picolinate Cap. 200mcg once daily for 24-weeks. | Drug | Chromium Picolinate |
| Placebo matching Chromium PicolinateAn inert capsule identical in appearance and packaging to the chromium picolinate 200 microgram capsule (same size, shape, color, weight, and dosing schedule), manufactured without active ingredient. The capsule shell is composed of gelatin or hypromellose, matching the active capsules. The capsule is filled with inert excipients suitable for oral capsules, such as microcrystalline cellulose and magnesium stearate, to replicate the weight and flow properties of the active capsules. Optional coloring agents are included as needed to match the active product. Capsules are packaged in sealed blisters to minimize odor, taste, and visual cues. Dispensed by the investigational pharmacy according to the randomization schedule; to be taken once daily. | Drug | Placebo Control |
Primary outcome
Change in the clinical severity of Acanthosis Nigricans
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified participant-level data, including acanthosis nigricans severity measurements, insulin resistance severity status, baseline demographics, and follow-up data relevant to primary outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghasak Kais Abdulhussain, BSc, MSc, PhD (Pharmacology) principal investigator
Uruk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chromium picolinate in people with Insulin Resistance and Acanthosis Nigricans, run by Uruk University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the clinical severity of Acanthosis Nigricans (time frame: Baseline, 8 weeks, 16 weeks, 24 weeks from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.