Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-02-23 @ 4:44 AM
Study NCT ID:
NCT02604095
Status:
COMPLETED
Last Update Posted:
2015-11-16
First Post:
2015-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000052', 'term': 'Acanthosis Nigricans'}, {'id': 'D009765', 'term': 'Obesity'}], '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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-13', 'studyFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2015-11-11', 'lastUpdatePostDateStruct': {'date': '2015-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insulin resistance index', 'timeFrame': '12 weeks', 'description': 'HOMA-IR:serum fasting insulin(mmol/L) × serum fasting glucose(mmol/L)/22.5'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '12 weeks', 'description': 'Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)'}, {'measure': 'Body weight', 'timeFrame': '12 weeks', 'description': 'Body weight (kg)'}, {'measure': 'Body fat', 'timeFrame': '12 weeks', 'description': 'Body fat (%)'}, {'measure': 'Neck circumference', 'timeFrame': '12 weeks', 'description': 'Neck circumference (cm)'}, {'measure': 'Waist circumference', 'timeFrame': '12 weeks', 'description': 'Waist circumference (cm)'}, {'measure': 'Total Cholesterol', 'timeFrame': '12 weeks', 'description': 'Total Cholesterol (mmol/L)'}, {'measure': 'Triglyceride', 'timeFrame': '12 weeks', 'description': 'Triglyceride (mmol/L)'}, {'measure': 'Low Density Lipoprotein', 'timeFrame': '12 weeks', 'description': 'Low Density Lipoprotein (mmol/L)'}, {'measure': 'High Density Lipoprotein', 'timeFrame': '12 weeks', 'description': 'High Density Lipoprotein (mmol/L)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acanthosis nigricans', 'Obesity'], 'conditions': ['Acanthosis Nigricans', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '29706998', 'type': 'DERIVED', 'citation': 'Sun H, Wang X, Chen J, Gusdon AM, Song K, Li L, Qu S. Melatonin Treatment Improves Insulin Resistance and Pigmentation in Obese Patients with Acanthosis Nigricans. Int J Endocrinol. 2018 Mar 12;2018:2304746. doi: 10.1155/2018/2304746. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism.', 'detailedDescription': 'The effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism in patient with obesity and acanthuses nigrican.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age:18-60 years old;\n* BMI ≥ 28 kg/m2；\n* With acanthosis nigricans。\n\nExclusion Criteria:\n\n* With liver, kidney, gastrointestinal or other major organic serious diseases, cancer, lactating women, pregnancy.'}, 'identificationModule': {'nctId': 'NCT02604095', 'briefTitle': 'Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism', 'orgStudyIdInfo': {'id': 'Melatonin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melatonin', 'description': 'Take one table at bedtime.', 'interventionNames': ['Dietary Supplement: melatonin']}], 'interventions': [{'name': 'melatonin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take one tablet (containing melatonin 3mg, calcium 52mg, vitamin B6 5mg) at bedtime everyday for 12 weeks.', 'armGroupLabels': ['Melatonin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Tenth People' Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Shen Qu, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': "Shanghai 10th People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhang Manna', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}