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CompletedNCT01125150Updated Sep 6, 2012

Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

An observational study in Acanthosis Nigricans, Hyperinsulinemia and Spectroscopic Analysis, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 11 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-06.

Sponsored by Henry Ford Health System · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
9
Ages
11 Years and older
Sex
All
01

Study summary

Acanthosis Nigricans is skin disease that associated with hyperinsulinemia. Clinical is velvety hyperpigmented plaques on neck, axilla, groin. If hyperinsulinemia is improved by treated with oral metformin and/ or diet control, acanthosis nigricans would be improved as well. Hyperpigmented plaques will be changed. We assess objective measurement by using spectroscopic and colorimetric analysis.

02

Conditions studied

  • Acanthosis Nigricans
  • Hyperinsulinemia
  • Spectroscopic Analysis

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Keywords

  • diffuse reflectance spectroscopy
03

In context

Hyperinsulinism

105 studies on the registry are indexed under Hyperinsulinism; 23 are open to participants now.

This study's enrollment of 9 is below the median of 50 across 17 observational studies indexed under Hyperinsulinism.

Browse Hyperinsulinism studies →

Lead sponsor

Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with both hyperinsulinemia and acanthosis nigricans.

Inclusion criteria

  1. Subjects must have an elevated fasting insulin level, suggesting they are in an insulin resistant state.
  2. Subjects must carry a diagnosis of acanthosis nigricans, which will be verified by a Dermatologist before entry into the study. If necessary, a small 4mm punch biopsy may be taken to document dermatopathology consistent with acanthosis nigricans.
  3. Subjects must be willing and able to undergo treatment with Metformin, including initial referral and follow up.
  4. Agree to abide by the investigator's guidelines
  5. Be able to understand the requirements of the study, the risks involved and are able to sign the informed consent form
  6. Agree to follow and undergo all study-related procedures

Exclusion criteria

Exclusion Criteria:

  1. Subjects with Type 1 Diabetes are excluded because of their naturally insulin-deficient, rather than hyper-insulinemic, states.
  2. Women who are lactating, pregnant, or planning to become pregnant.

  3. Any reason the investigator feels the patient should not participate in the study.

    -

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
9 participants (actual)

Interventions

  • DrugMetformin

    Dosage to be determined by Endocrinologist

  • BehavioralDietary Modification

    To be determined by Endocrinologist

06

Study locations

1 site
  • Department of Dermatology, NEW CENTER ONE
    Detroit, Michigan 48202, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01125150
Lead sponsor
Henry Ford Health System
Responsible party
Iltefat Hamzavi (Dermatologist, Henry Ford Health System) — Principal investigator
First posted
May 18, 2010
Start date
Feb 2009
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Sep 6, 2012

Study contacts

Iltefat Hamzavi, M.D.
principal investigator · Department of Dermatology, Henry Ford Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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