Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04251559
Other study ID # 240785
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2014
Est. completion date June 30, 2019

Study information

Verified date January 2020
Source Derince Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 374
Est. completion date June 30, 2019
Est. primary completion date January 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 44 Years
Eligibility 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

Study Design


Intervention

Other:
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.

Locations

Country Name City State
Turkey Derince Training and Research Hospital Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (19)

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. — View Citation

Bratke H, Bruserud IS, Brannsether B, Aßmus J, Bjerknes R, Roelants M, Júlíusson 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Epub 2007 Aug 6. — View 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. — View 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. Epub 2003 Apr 30. — View Citation

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

* Note: There are 19 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Gestational diabetes mellitus risk faktors It was evaluated whether the menarche age of pregnant women with gestational diabetes was different from pregnancy without gestational diabetes. From the 24th week of pregnancy to the delivery
See also
  Status Clinical Trial Phase
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06437782 - Exploration of Health Literacy in Diabetes in Reunion Island and France
Completed NCT01940003 - Effects of an Aquatic Physical Exercise Program on Glycaemic Control and Perinatal Outcomes of Gestational Diabetes: Study Protocol for a Randomized Controlled Trial N/A
Completed NCT02960295 - The Virtual Visit for Women With Gestational Diabetes N/A
Completed NCT01919476 - Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women N/A
Completed NCT05512871 - A Mobile Health-enabled Lifestyle Intervention Among Women With History of Gestational Diabetes(GDM) N/A
Enrolling by invitation NCT03307486 - Gestational Diabetes: a Cohort Study N/A
Active, not recruiting NCT04417452 - Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy
Completed NCT02968628 - Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)
Active, not recruiting NCT04222348 - MeDiGes Study: Metformine Use in Gestational Diabetes Phase 3
Completed NCT03007186 - Glucose Monitoring During Threatening Preterm Birth in Patients With and Without Gestational Diabetes Mellitus
Completed NCT00069576 - Gestational Diabetes Mellitus Trial (GDM) N/A
Completed NCT04866823 - Meals for Moms: Medically-Tailored Meals for Women Who Had Gestational Diabetes N/A
Recruiting NCT04198857 - Development and Testing of a Mobile Health Application for Management of Gestational Diabetes N/A
Recruiting NCT05115188 - DIAgnosing GDM usiNg Oral Sugar InStead Phase 2
Recruiting NCT03607799 - A Culturally-tailored Personalized Nutrition Intervention in South Asian Women at Risk of Gestational Diabetes N/A
Recruiting NCT02893072 - Medical Nutrition Therapy Intervention Program for Women With Gestational Diabetes--a Prospective Study N/A
Enrolling by invitation NCT05368220 - Translating Genetic Knowledge Into Clinical Care in Non-Autoimmune Diabetes
Completed NCT02770079 - Insulin Sensitivity and Secretion During Pregnancy and Post Partum in Women With Gestational Diabetes.
Completed NCT00681460 - Metformin in Gestational Diabetes Mellitus N/A