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OpenTrials
Completed

NCT Number: NCT01125150

Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

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.

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Key information

Conditions

Acanthosis Nigricans Glucose Metabolism Disorders Hyperinsulinemia Hyperinsulinism Hyperpigmentation Melanosis Metabolic Diseases Nutritional and Metabolic Diseases Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Spectroscopic Analysis

Age range

11 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dermatology, NEW CENTER ONE

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must have an elevated fasting insulin level, suggesting they are in an insulin resistant state.
  • 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.
  • Subjects must be willing and able to undergo treatment with Metformin, including initial referral and follow up.
  • Agree to abide by the investigator's guidelines
  • Be able to understand the requirements of the study, the risks involved and are able to sign the informed consent form
  • Agree to follow and undergo all study-related procedures

Exclusion criteria

  • Subjects with Type 1 Diabetes are excluded because of their naturally insulin-deficient, rather than hyper-insulinemic, states.
  • Women who are lactating, pregnant, or planning to become pregnant.
  • Any reason the investigator feels the patient should not participate in the study.

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Treatment and study plan

metformin

Drug

Dosage to be determined by Endocrinologist

Dietary Modification

Behavioral

To be determined by Endocrinologist

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 18, 2010
Registry last updated
Sep 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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