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Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01125150
First received: May 12, 2010
Last updated: September 4, 2012
Last verified: May 2010
History of Changes
  Purpose

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 Intervention
Acanthosis Nigricans
Hyperinsulinemia
Spectroscopic Analysis
 Drug: Metformin
Behavioral: Dietary Modification

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Enrollment: 9
Study Start Date: February 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Metformin
    Dosage to be determined by Endocrinologist
    Behavioral: Dietary Modification
    To be determined by Endocrinologist
  Eligibility

Ages Eligible for Study:   11 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with both hyperinsulinemia and acanthosis nigricans.

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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125150

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

No publications provided

Responsible Party: Iltefat Hamzavi, Dermatologist, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01125150     History of Changes
Other Study ID Numbers: IRB5339
Study First Received: May 12, 2010
Last Updated: September 4, 2012
Health Authority: Henry Ford Health System: Institutional Review Board

Keywords provided by Henry Ford Health System:
diffuse reflectance spectroscopy

Additional relevant MeSH terms:
Acanthosis Nigricans
Hyperinsulinism
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
 Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013