Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-27 @ 1:17 AM
Study NCT ID:
NCT04251559
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2020-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Risk Factors for Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 374}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-29', 'studyFirstSubmitDate': '2020-01-17', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gestational diabetes mellitus risk faktors', 'timeFrame': 'From the 24th week of pregnancy to the delivery', 'description': 'It was evaluated whether the menarche age of pregnant women with gestational diabetes was different from pregnancy without gestational diabetes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['menarche', 'gestational diabetes mellitus', 'cycle, menstrual'], 'conditions': ['Diabetes, Gestational', 'Menstrual Cycle Abnormal']}, 'referencesModule': {'references': [{'pmid': '19465232', 'type': 'BACKGROUND', 'citation': 'Bellamy L, Casas JP, Hingorani AD, Williams D. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet. 2009 May 23;373(9677):1773-9. doi: 10.1016/S0140-6736(09)60731-5.'}, {'pmid': '28587648', 'type': 'BACKGROUND', 'citation': 'Bratke H, Bruserud IS, Brannsether B, Assmus J, Bjerknes R, Roelants M, Juliusson PB. Timing of menarche in Norwegian girls: associations with body mass index, waist circumference and skinfold thickness. BMC Pediatr. 2017 Jun 6;17(1):138. doi: 10.1186/s12887-017-0893-x.'}, {'pmid': '26813668', 'type': 'BACKGROUND', 'citation': 'Chen L, Li S, He C, Zhu Y, Buck Louis GM, Yeung E, Hu FB, Zhang C. Age at Menarche and Risk of Gestational Diabetes Mellitus: A Prospective Cohort Study Among 27,482 Women. Diabetes Care. 2016 Mar;39(3):469-71. doi: 10.2337/dc15-2011. Epub 2016 Jan 26.'}, {'pmid': '30628040', 'type': 'BACKGROUND', 'citation': 'De Sanctis V, Rigon F, Bernasconi S, Bianchin L, Bona G, Bozzola M, Buzi F, De Sanctis C, Tonini G, Radetti G, Perissinotto E. Age at Menarche and Menstrual Abnormalities in Adolescence: Does it Matter? The Evidence from a Large Survey among Italian Secondary Schoolgirls. Indian J Pediatr. 2019 Jan;86(Suppl 1):34-41. doi: 10.1007/s12098-018-2822-x. Epub 2019 Jan 10.'}, {'pmid': '24945238', 'type': 'BACKGROUND', 'citation': 'DeSisto CL, Kim SY, Sharma AJ. Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007-2010. Prev Chronic Dis. 2014 Jun 19;11:E104. doi: 10.5888/pcd11.130415.'}, {'pmid': '21816498', 'type': 'BACKGROUND', 'citation': 'Dishi M, Enquobahrie DA, Abetew DF, Qiu C, Rudra CB, Williams MA. Age at menarche, menstrual cycle characteristics and risk of gestational diabetes. Diabetes Res Clin Pract. 2011 Sep;93(3):437-42. doi: 10.1016/j.diabres.2011.07.001. Epub 2011 Aug 3.'}, {'pmid': '17675039', 'type': 'BACKGROUND', 'citation': 'Feng Y, Hong X, Wilker E, Li Z, Zhang W, Jin D, Liu X, Zang T, Xu X, Xu X. Effects of age at menarche, reproductive years, and menopause on metabolic risk factors for cardiovascular diseases. Atherosclerosis. 2008 Feb;196(2):590-7. doi: 10.1016/j.atherosclerosis.2007.06.016. Epub 2007 Aug 6.'}, {'pmid': '28215584', 'type': 'BACKGROUND', 'citation': 'Flom JD, Cohn BA, Tehranifar P, Houghton LC, Wei Y, Protacio A, Cirillo P, Michels KB, Terry MB. Earlier age at menarche in girls with rapid early life growth: cohort and within sibling analyses. Ann Epidemiol. 2017 Mar;27(3):187-193.e2. doi: 10.1016/j.annepidem.2017.01.004. Epub 2017 Jan 19.'}, {'pmid': '12723990', 'type': 'BACKGROUND', 'citation': 'Freedman DS, Khan LK, Serdula MK, Dietz WH, Srinivasan SR, Berenson GS; Bogalusa heart study. The relation of menarcheal age to obesity in childhood and adulthood: the Bogalusa heart study. BMC Pediatr. 2003 Apr 30;3:3. doi: 10.1186/1471-2431-3-3. Epub 2003 Apr 30.'}, {'pmid': '19015764', 'type': 'BACKGROUND', 'citation': 'Gilmartin AB, Ural SH, Repke JT. Gestational diabetes mellitus. Rev Obstet Gynecol. 2008 Summer;1(3):129-34.'}, {'pmid': '20026580', 'type': 'BACKGROUND', 'citation': 'He C, Zhang C, Hunter DJ, Hankinson SE, Buck Louis GM, Hediger ML, Hu FB. Age at menarche and risk of type 2 diabetes: results from 2 large prospective cohort studies. Am J Epidemiol. 2010 Feb 1;171(3):334-44. doi: 10.1093/aje/kwp372. Epub 2009 Dec 21.'}, {'pmid': '18320165', 'type': 'BACKGROUND', 'citation': 'Lakshman R, Forouhi N, Luben R, Bingham S, Khaw K, Wareham N, Ong KK. Association between age at menarche and risk of diabetes in adults: results from the EPIC-Norfolk cohort study. Diabetologia. 2008 May;51(5):781-6. doi: 10.1007/s00125-008-0948-5. Epub 2008 Mar 5.'}, {'pmid': '19880785', 'type': 'BACKGROUND', 'citation': 'Lakshman R, Forouhi NG, Sharp SJ, Luben R, Bingham SA, Khaw KT, Wareham NJ, Ong KK. Early age at menarche associated with cardiovascular disease and mortality. J Clin Endocrinol Metab. 2009 Dec;94(12):4953-60. doi: 10.1210/jc.2009-1789. Epub 2009 Oct 30.'}, {'pmid': '30606158', 'type': 'BACKGROUND', 'citation': 'Lian Q, Mao Y, Luo S, Zhang S, Tu X, Zuo X, Lou C, Zhou W. Puberty timing associated with obesity and central obesity in Chinese Han girls. BMC Pediatr. 2019 Jan 3;19(1):1. doi: 10.1186/s12887-018-1376-4.'}, {'pmid': '28161369', 'type': 'BACKGROUND', 'citation': 'Li H, Shen L, Song L, Liu B, Zheng X, Xu S, Wang Y. Early age at menarche and gestational diabetes mellitus risk: Results from the Healthy Baby Cohort study. Diabetes Metab. 2017 Jun;43(3):248-252. doi: 10.1016/j.diabet.2017.01.002. Epub 2017 Feb 1.'}, {'pmid': '27456304', 'type': 'BACKGROUND', 'citation': 'Shen Y, Hu H, D Taylor B, Kan H, Xu X. Early Menarche and Gestational Diabetes Mellitus at First Live Birth. Matern Child Health J. 2017 Mar;21(3):593-598. doi: 10.1007/s10995-016-2143-5.'}, {'pmid': '29556913', 'type': 'BACKGROUND', 'citation': 'Sun X, Yang L, Pan J, Yang H, Wu Y, Chen Z, Chen X, Mu L. Age at menarche and the risk of gestational diabetes mellitus: a systematic review and meta-analysis. Endocrine. 2018 Aug;61(2):204-209. doi: 10.1007/s12020-018-1581-9. Epub 2018 Mar 20.'}, {'pmid': '18710713', 'type': 'BACKGROUND', 'citation': 'Toulis KA, Goulis DG, Kolibianakis EM, Venetis CA, Tarlatzis BC, Papadimas I. Risk of gestational diabetes mellitus in women with polycystic ovary syndrome: a systematic review and a meta-analysis. Fertil Steril. 2009 Aug;92(2):667-77. doi: 10.1016/j.fertnstert.2008.06.045. Epub 2008 Aug 16.'}, {'pmid': '29682210', 'type': 'BACKGROUND', 'citation': 'Xiao Y, Chen R, Chen M, Luo A, Chen D, Liang Q, Cai Y, Chen L, Zhao X. Age at menarche and risks of gestational diabetes mellitus: a meta-analysis of prospective studies. Oncotarget. 2017 Dec 23;9(24):17133-17140. doi: 10.18632/oncotarget.23658. eCollection 2018 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'This study examines the relationship between the age at menarche and gestational diabetes mellitus (GDM). In this retrospective study, the sample included all pregnant women diagnosed with GDM in a pregnancy polyclinic in Kocaeli, Turkey between 2014 and 2019. The sample included 373 participants: 233 in the GDM group and 140 in the control group. The groups were compared in terms of age at menarche.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women with gestational diabetes\n\nExclusion Criteria:\n\n* Patients with hypertension and pregestational diabetes mellitus\n* Patients with rheumatologic, nephrological, and hematological diseases\n* Presence of active infection,\n* corticosteroid use, acetylsalicylic acid, and anticoagulant use'}, 'identificationModule': {'nctId': 'NCT04251559', 'briefTitle': 'Evaluation of Risk Factors for Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Derince Training and Research Hospital'}, 'officialTitle': 'Evaluation of the Relationship Between Age at Menarche and Gestational Diabetes Mellitus', 'orgStudyIdInfo': {'id': '240785'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'patients with gestational diabetes mellitus', 'description': 'study group', 'interventionNames': ['Other: oral glucose loading test']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'healthy participants', 'description': 'control group', 'interventionNames': ['Other: oral glucose loading test']}], 'interventions': [{'name': 'oral glucose loading test', 'type': 'OTHER', 'description': 'oral glucose loading test was performed to all participants. gestational diabetes and control group were compared in terms of menarche age.', 'armGroupLabels': ['healthy participants', 'patients with gestational diabetes mellitus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1260', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Derince Training and Research Hospital', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'mehmet ozsurmeli', 'role': 'STUDY_CHAIR', 'affiliation': 'Derince Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Derince Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'mehmet ozsurmeli', 'investigatorAffiliation': 'Derince Training and Research Hospital'}}}}