Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-01 @ 7:36 PM
Study NCT ID:
NCT01125150
Status:
COMPLETED
Last Update Posted:
2012-09-06
First Post:
2010-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000052', 'term': 'Acanthosis Nigricans'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}], 'ancestors': [{'id': 'D008548', 'term': 'Melanosis'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-04', 'studyFirstSubmitDate': '2010-05-12', 'studyFirstSubmitQcDate': '2010-05-17', 'lastUpdatePostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diffuse reflectance spectroscopy'], 'conditions': ['Acanthosis Nigricans', 'Hyperinsulinemia', 'Spectroscopic Analysis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '11 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with both hyperinsulinemia and acanthosis nigricans.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects must have an elevated fasting insulin level, suggesting they are in an insulin resistant state.\n2. 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.\n3. Subjects must be willing and able to undergo treatment with Metformin, including initial referral and follow up.\n4. Agree to abide by the investigator's guidelines\n5. Be able to understand the requirements of the study, the risks involved and are able to sign the informed consent form\n6. Agree to follow and undergo all study-related procedures\n\nExclusion Criteria:\n\n1. Subjects with Type 1 Diabetes are excluded because of their naturally insulin-deficient, rather than hyper-insulinemic, states.\n2. Women who are lactating, pregnant, or planning to become pregnant.\n3. Any reason the investigator feels the patient should not participate in the study.\n\n \\-"}, 'identificationModule': {'nctId': 'NCT01125150', 'briefTitle': 'Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'orgStudyIdInfo': {'id': 'IRB5339'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'Dosage to be determined by Endocrinologist'}, {'name': 'Dietary Modification', 'type': 'BEHAVIORAL', 'description': 'To be determined by Endocrinologist'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Department of Dermatology, NEW CENTER ONE', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Iltefat Hamzavi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, Henry Ford Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dermatologist', 'investigatorFullName': 'Iltefat Hamzavi', 'investigatorAffiliation': 'Henry Ford Health System'}}}}