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. |
---|---|
Condition | Acanthosis Nigricans Hyperinsulinemia Spectroscopic Analysis |
Intervention | Drug: Metformin Behavioral: Dietary Modification |
Phase | N/A |
Sponsor | Henry Ford Health System |
Responsible Party | Henry Ford Health System |
ClinicalTrials.gov Identifier | NCT01125150 |
First Received | May 12, 2010 |
Last Updated | September 4, 2012 |
Last verified | May 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | May 12, 2010 |
---|---|
Last Updated Date | September 4, 2012 |
Start Date | February 2009 |
Estimated Primary Completion Date | June 2012 |
Current Primary Outcome Measures | Not Provided |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia |
---|---|
Official Title | Not 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 Description | Not Provided |
Study Type | Observational |
Study Phase | N/A |
Study Design | Observational Model: Case Control, Time Perspective: Prospective |
Condition |
|
Intervention | Drug: Metformin Dosage to be determined by Endocrinologist Behavioral: Dietary Modification To be determined by Endocrinologist |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 9 |
Estimated Completion Date | June 2012 |
Estimated Primary Completion Date | June 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. - |
Gender | Both |
Ages | 11 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01125150 |
---|---|
Other Study ID Numbers | IRB5339 |
Has Data Monitoring Committee | Yes |
Information Provided By | Henry Ford Health System |
Study Sponsor | Henry Ford Health System |
Collaborators | Not Provided |
Investigators | Principal Investigator: Iltefat Hamzavi, M.D. Department of Dermatology, Henry Ford Hospital |
Verification Date | May 2010 |
Locations[ + expand ][ + ]
Department of Dermatology, NEW CENTER ONE | Detroit, Michigan, United States, 48202 |
---|