Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

Hyperinsulinemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125150
• Other study ID #: IRB5339
• Status: Completed
• Phase: N/A
• First received: May 12, 2010
• Last updated: September 4, 2012
• Start date: February 2009
• Est. completion date: June 2012

Study information

• Verified date: May 2010
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: Henry Ford Health System: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years and older

Eligibility

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:

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acanthosis Nigricans
• Hyperinsulinemia
• Hyperinsulinism
• Spectroscopic Analysis

Intervention

Drug:
• Metformin
Dosage to be determined by Endocrinologist

Behavioral:
• Dietary Modification
To be determined by Endocrinologist

Locations

Country	Name	City	State
United States	Department of Dermatology, NEW CENTER ONE	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States,