Evaluation of Risk Factors for Gestational Diabetes Mellitus

NCT ID: NCT04251559

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes, Gestational Menstrual Cycle Abnormal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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patients with gestational diabetes mellitus

study group

Group Type ACTIVE_COMPARATOR

oral glucose loading test

Intervention Type OTHER

oral glucose loading test was performed to all participants. gestational diabetes and control group were compared in terms of menarche age.

healthy participants

control group

Group Type PLACEBO_COMPARATOR

oral glucose loading test

Intervention Type OTHER

oral glucose loading test was performed to all participants. gestational diabetes and control group were compared in terms of menarche age.

Interventions

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oral glucose loading test

oral glucose loading test was performed to all participants. gestational diabetes and control group were compared in terms of menarche age.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* pregnant women with gestational diabetes

Exclusion Criteria

* Patients with hypertension and pregestational diabetes mellitus
* Patients with rheumatologic, nephrological, and hematological diseases
* Presence of active infection,
* corticosteroid use, acetylsalicylic acid, and anticoagulant use
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Derince Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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mehmet ozsurmeli

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mehmet ozsurmeli

Role: STUDY_CHAIR

Derince Training and Research Hospital

Locations

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Derince Training and Research Hospital

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 19465232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28587648 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26813668 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 24945238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21816498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17675039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28215584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12723990 (View on PubMed)

Gilmartin AB, Ural SH, Repke JT. Gestational diabetes mellitus. Rev Obstet Gynecol. 2008 Summer;1(3):129-34.

Reference Type BACKGROUND
PMID: 19015764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20026580 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18320165 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 27456304 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 29682210 (View on PubMed)

Other Identifiers

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240785

Identifier Type: -

Identifier Source: org_study_id

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