Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

NCT01125150 | Completed DMC

• 1 other identifier: IRB5339
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Acanthosis Nigricans; Hyperinsulinemia; Spectroscopic Analysis

Keywords

diffuse reflectance spectroscopy

Interventions

Metformin DRUG

Dosage to be determined by Endocrinologist

Dietary Modification BEHAVIORAL

To be determined by Endocrinologist

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with both hyperinsulinemia and acanthosis nigricans.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Department of Dermatology, NEW CENTER ONE

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Acanthosis Nigricans; Hyperinsulinism

Interventions

Metformin; Diet Therapy

Condition Hierarchy (Ancestors)

Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Nutrition Therapy; Therapeutics

Study Officials

• Iltefat Hamzavi, M.D.

  Department of Dermatology, Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: May 18, 2010
• Study Start: February 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 6, 2012

Record last verified: 2010-05

Locations

US (1)