Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 6:58 PM
Study NCT ID:
NCT00631033
Status:
COMPLETED
Last Update Posted:
2014-11-06
First Post:
2008-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DZX Mediated Insulin Suppression in Obese Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}], 'ancestors': [{'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'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003981', 'term': 'Diazoxide'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-05', 'studyFirstSubmitDate': '2008-02-27', 'studyFirstSubmitQcDate': '2008-02-27', 'lastUpdatePostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['obesity', 'hyperinsulinism', 'diazoxide', 'metformin'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '30202851', 'type': 'DERIVED', 'citation': 'Loves S, van Groningen L, Filius M, Mekking M, Brandon T, Tack CJ, Hermus A, de Boer H. High-Dose, Diazoxide-Mediated Insulin Suppression Boosts Weight Loss Induced by Lifestyle Intervention. J Clin Endocrinol Metab. 2018 Nov 1;103(11):4014-4022. doi: 10.1210/jc.2018-01147.'}, {'pmid': '29618011', 'type': 'DERIVED', 'citation': 'Loves S, van Groningen L, Filius M, Mekking M, Brandon T, Tack CJ, Hermus A, de Boer H. Effects of Diazoxide-Mediated Insulin Suppression on Glucose and Lipid Metabolism in Nondiabetic Obese Men. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2346-2353. doi: 10.1210/jc.2018-00161.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether there is an additive effect of metformine on the weight reduction of obese hyperinsulinemic men who are treated with diazoxide.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* age 25-50 years\n* BMI 30-35 kg/m2\n* stable body weight during 3 months before the start of the study\n* glucose \\<= 6.0 mmol/L\n* C-peptide \\>= 1.0 nmol/L\n* HbA1c \\<= 6.0%\n\nExclusion Criteria:\n\n* comorbidity\n* medication\n* serum creatinine \\> 120 micromol/L\n* liver enzymes \\> 2 times upper limits of normal\n* gout\n* alcohol use \\> 2 alcoholic drinks a day\n* drug abuse\n* cessation of smoking less than 6 months ago'}, 'identificationModule': {'nctId': 'NCT00631033', 'briefTitle': 'DZX Mediated Insulin Suppression in Obese Men', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Diazoxide-mediated Insulin Suppression in Hyperinsulinemic Obese Men, Part III', 'orgStudyIdInfo': {'id': 'LTC-511-230108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Diazoxide', 'interventionNames': ['Drug: Diazoxide']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Metformin + Diazoxide', 'interventionNames': ['Drug: Metformin + Diazoxide']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Diazoxide', 'type': 'DRUG', 'armGroupLabels': ['2']}, {'name': 'Metformin + Diazoxide', 'type': 'DRUG', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}}}}