Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

NCT ID: NCT01125150

Last Updated: 2012-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-06-30

Brief Summary

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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 Description

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Conditions

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Acanthosis Nigricans Hyperinsulinemia Spectroscopic Analysis

Keywords

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diffuse reflectance spectroscopy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Metformin

Dosage to be determined by Endocrinologist

Intervention Type DRUG

Dietary Modification

To be determined by Endocrinologist

Intervention Type BEHAVIORAL

Eligibility Criteria

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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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Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Iltefat Hamzavi

Dermatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iltefat Hamzavi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Henry Ford Hospital

Locations

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Department of Dermatology, NEW CENTER ONE

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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IRB5339

Identifier Type: -

Identifier Source: org_study_id