Trial record 29 of 2491 for:    hyperinsulinism

Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01125150
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : September 6, 2012
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System

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.

Condition or disease Intervention/treatment
Acanthosis Nigricans Hyperinsulinemia Spectroscopic Analysis Drug: Metformin Behavioral: Dietary Modification

Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : February 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Intervention Details:
  • Drug: Metformin
    Dosage to be determined by Endocrinologist
  • Behavioral: Dietary Modification
    To be determined by Endocrinologist

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01125150

United States, Michigan
Department of Dermatology, NEW CENTER ONE
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Principal Investigator: Iltefat Hamzavi, M.D. Department of Dermatology, Henry Ford Hospital

Responsible Party: Iltefat Hamzavi, Dermatologist, Henry Ford Health System Identifier: NCT01125150     History of Changes
Other Study ID Numbers: IRB5339
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: September 6, 2012
Last Verified: May 2010

Keywords provided by Iltefat Hamzavi, Henry Ford Health System:
diffuse reflectance spectroscopy

Additional relevant MeSH terms:
Acanthosis Nigricans
Glucose Metabolism Disorders
Metabolic Diseases
Pigmentation Disorders
Skin Diseases