Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

Brief Title

Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia


Brief 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.
    



Study Type

Observational




Condition

Acanthosis Nigricans

Intervention

Metformin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

9

Start Date

February 2009

Completion Date

June 2012

Primary Completion Date

June 2012

Eligibility Criteria

        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.

             -
      

Gender

All

Ages

11 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Iltefat Hamzavi, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01125150

Organization ID

IRB5339


Responsible Party

Principal Investigator

Study Sponsor

Henry Ford Health System


Study Sponsor

Iltefat Hamzavi, M.D., Principal Investigator, Department of Dermatology, Henry Ford Hospital


Verification Date

May 2010