Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

Overview[ - collapse ][ - ]

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.
ConditionAcanthosis Nigricans
Hyperinsulinemia
Spectroscopic Analysis
InterventionDrug: Metformin
Behavioral: Dietary Modification
PhaseN/A
SponsorHenry Ford Health System
Responsible PartyHenry Ford Health System
ClinicalTrials.gov IdentifierNCT01125150
First ReceivedMay 12, 2010
Last UpdatedSeptember 4, 2012
Last verifiedMay 2010

Tracking Information[ + expand ][ + ]

First Received DateMay 12, 2010
Last Updated DateSeptember 4, 2012
Start DateFebruary 2009
Estimated Primary Completion DateJune 2012
Current Primary Outcome MeasuresNot Provided
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleSpectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia
Official TitleNot Provided
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.
Detailed DescriptionNot Provided
Study TypeObservational
Study PhaseN/A
Study DesignObservational Model: Case Control, Time Perspective: Prospective
Condition
  • Acanthosis Nigricans
  • Hyperinsulinemia
  • Spectroscopic Analysis
InterventionDrug: Metformin
Dosage to be determined by Endocrinologist
Behavioral: Dietary Modification
To be determined by Endocrinologist
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment9
Estimated Completion DateJune 2012
Estimated Primary Completion DateJune 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.

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GenderBoth
Ages11 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01125150
Other Study ID NumbersIRB5339
Has Data Monitoring CommitteeYes
Information Provided ByHenry Ford Health System
Study SponsorHenry Ford Health System
CollaboratorsNot Provided
Investigators Principal Investigator: Iltefat Hamzavi, M.D. Department of Dermatology, Henry Ford Hospital
Verification DateMay 2010

Locations[ + expand ][ + ]

Department of Dermatology, NEW CENTER ONE
Detroit, Michigan, United States, 48202