Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT01487993
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2011-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metformin in Obese Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2011-10-20', 'studyFirstSubmitQcDate': '2011-12-06', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BMI from baseline', 'timeFrame': '18 months and 36 months', 'description': 'Change in BMI after part 1 (double blind) and part 2 ( follow-up)'}, {'measure': 'Change in Insulin resistance from baseline', 'timeFrame': '3; 6; 9; 12; 15; 18; 24; 30 and 36 months', 'description': 'calculated by the Homeostasis Model Assessment for Insulin Resistance (HOMA-IR).'}], 'secondaryOutcomes': [{'measure': 'Renal and hepatic function', 'timeFrame': '3; 6; 9; 12; 15; 18; 24; 30 and 36 months', 'description': 'creatinine and alat'}, {'measure': 'Tolerability', 'timeFrame': '3; 6; 9; 12; 15; 18; 24; 30 and 36 months', 'description': 'The amount of reported adverse effects, in relation to the achieved dose level.'}, {'measure': 'Pharmacokinetics (PK)-parameters: clearance (ml/min)', 'timeFrame': '9 months', 'description': 'Clearance where applicable expressed per body weight, age category, Tanner Stage and gender, clearance will be determined with a two-compartment pharmacokinetic model using non linear mixed effect modelling.'}, {'measure': 'Body fat percentage', 'timeFrame': '0, 9, 18 and 36 months'}, {'measure': 'Physical fitness', 'timeFrame': '0, 9, 18 and 36 months'}, {'measure': 'Quality of life', 'timeFrame': '0, 9, 18 and 36 months'}, {'measure': 'Long term efficacy', 'timeFrame': '36 months', 'description': 'Based on BMI and HOMA-IR values'}, {'measure': 'Long-term safety', 'timeFrame': '36 months', 'description': 'Renal and hepatic function after 36 months of metformin use'}, {'measure': 'Long-term tolerability', 'timeFrame': '36 months', 'description': 'The amount of adverse effects after 36 months'}, {'measure': 'Microvascular complications', 'timeFrame': '36 months', 'description': 'Measured as micro-albuminuria'}, {'measure': 'Macrovascular complications', 'timeFrame': '36 monthts', 'description': 'Measured with Pulse Wave Velocity and Augmentation Index.'}, {'measure': 'Development of T2DM', 'timeFrame': '36 months'}, {'measure': 'PK-parameters: volume of distribution (liters)', 'timeFrame': '9 months', 'description': 'Volume of distribution, where applicable expressed per body weight, age category, Tanner Stage and gender, volume of distribution will be determined with a two-compartment pharmacokinetic model using non linear mixed effect modelling.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'Children', 'Adolescents', 'Metformin', 'Insulin resistance'], 'conditions': ['Obesity', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '29748932', 'type': 'DERIVED', 'citation': 'van Rongen A, van der Aa MP, Matic M, van Schaik RHN, Deneer VHM, van der Vorst MM, Knibbe CAJ. Increased Metformin Clearance in Overweight and Obese Adolescents: A Pharmacokinetic Substudy of a Randomized Controlled Trial. Paediatr Drugs. 2018 Aug;20(4):365-374. doi: 10.1007/s40272-018-0293-1.'}, {'pmid': '28101379', 'type': 'DERIVED', 'citation': 'van der Aa MP, Hoving V, van de Garde EM, de Boer A, Knibbe CA, van der Vorst MM. The Effect of Eighteen-Month Metformin Treatment in Obese Adolescents: Comparison of Results Obtained in Daily Practice with Results from a Clinical Trial. J Obes. 2016;2016:7852648. doi: 10.1155/2016/7852648. Epub 2016 Dec 22.'}, {'pmid': '24899137', 'type': 'DERIVED', 'citation': 'van der Aa MP, Elst MA, van Mil EG, Knibbe CA, van der Vorst MM. METFORMIN: an efficacy, safety and pharmacokinetic study on the short-term and long-term use in obese children and adolescents - study protocol of a randomized controlled study. Trials. 2014 Jun 5;15:207. doi: 10.1186/1745-6215-15-207.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether metformin is effective in reducing BMI and insulin resistance in obese children and adolescents.', 'detailedDescription': 'The prevalence of obesity in children and adolescents is increasing rapidly and is associated with significant medical and psychosocial consequences persisting into adulthood.\n\nObesity may lead to metabolic complications, such as insulin resistance, which can progress via impaired fasted glucose and impaired glucose tolerance to type 2 diabetes mellitus (T2DM) and to the development of micro- and macro-vascular complications.\n\nMetformin, an oral anti-diabetic licensed for T2DM for adults and children from 10 years onwards, is already used off label in obese children and adolescents with insulin resistance, even though the specific effects of metformin in these obese children and adolescents have not been elucidated, particularly upon long-term use.\n\nThe rationale for this study is based on the hypothesis that metformin may reduce body mass index (BMI), insulin resistance and percentage of body-fat in obese children and adolescents with insulin resistance. Further more it is anticipated that metformin may delay the progression to T2DM and thereby micro- and macro-vascular complications in obese children and adolescents with insulin resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 10 and ≤ 16 years at study entry\n* Caucasian descent\n* Obesity defined as BMI-SDS \\> 2.3\n* Insulin resistance defined as HOMA-IR ≥ 3.4.\n* An obtained informed consent from subjects and parents/caregivers.\n\nExclusion Criteria:\n\n* Presence of T2DM (American Diabetes Association criteria)\n* Presence of endocrine disorders with steroid therapy\n* Suspicion of polycystic ovarium syndrome;\n* Height \\< -1.3 SD of target height;\n* Syndrome disorders with or without mental retardation;\n* Use of anti-hyperglycaemic drugs;\n* Pregnancy (pregnancy test will be performed, if applicable);\n* (History of) alcohol abuse;\n* Impaired renal and/or hepatic function (defined as GFR \\< 80 ml/min. GFR=40 x length (cm) / serumcreatinin (μmol/l and ALAT \\>150% of normal value for age);\n* Use of ritonavir; use of ACE inhibitors;\n* Insufficient knowledge of the Dutch language.'}, 'identificationModule': {'nctId': 'NCT01487993', 'acronym': 'MetVoorMin', 'briefTitle': 'Metformin in Obese Children and Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'St. Antonius Hospital'}, 'officialTitle': 'An Efficacy, Safety and Pharmacokinetic Study on the Short-term and Long-term Use of Metformin in Obese Children and Adolescents', 'orgStudyIdInfo': {'id': 'Metformin 2011-6'}, 'secondaryIdInfos': [{'id': '2010-023980-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'Metformin with lifestyle intervention during 18 months', 'interventionNames': ['Drug: Metformin', 'Behavioral: Lifestyle intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo and lifestyle intervention during 18 months', 'interventionNames': ['Behavioral: Lifestyle intervention']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'Oral administration, 500 mg daily at week 1. Every week metformin dosage increases with 500 mg, to a maximum dose of 1000 mg bid. This maximum dose will be administered till the end of the study.', 'armGroupLabels': ['Metformin']}, {'name': 'Lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'Lifestyle intervention: 18 months physical therapy and dietary advice', 'armGroupLabels': ['Metformin', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': "'s-Hertogenbosch", 'country': 'Netherlands', 'facility': 'Jeroen Bosch Hospital', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'zip': '3430EM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}], 'overallOfficials': [{'name': 'Marja MJ van der Vorst, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Antonius Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Antonius Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jeroen Bosch Ziekenhuis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mrs. M.M.J. van der Vorst, paediatrician-clinical pharmacologist', 'investigatorFullName': 'Van der Vorst', 'investigatorAffiliation': 'St. Antonius Hospital'}}}}