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AzTrials

Diabetes, GestationalNCT04251559

Evaluation of Risk Factors for Gestational Diabetes Mellitus

A study testing oral glucose loading test in people with Diabetes, Gestational and Menstrual Cycle Abnormal, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 44 years, women onlyHealthy volunteers can take part
What is being tested?
oral glucose loading test
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
374 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2014to 30 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 44 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • pregnant women with gestational diabetes

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Derince Training and Research Hospital

    Kocaeli, 1260

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Relationship Between Age at Menarche and Gestational Diabetes Mellitus

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.

Being tested
oral glucose loading test
Keywords
menarche, gestational diabetes mellitus, cycle, menstrual
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oral glucose loading testOther

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

Study groups in NCT04251559
Study groupRoleWhat they receive
patients with gestational diabetes mellitusActive comparatorstudy group
Receives: Other: oral glucose loading test
healthy participantsPlacebo comparatorcontrol group
Receives: Other: oral glucose loading test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From the 24th week of pregnancy to the delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start1 Jan 2014
  3. Primary completion30 Jan 2018
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04251559
Sponsor's protocol ID
240785
Status last verified
Jan 2020
First submitted
17 Jan 2020
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19465232

  • 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.

    PubMed 28587648

  • 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.

    PubMed 26813668

  • 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.

    PubMed 30628040

  • 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.

    PubMed 24945238

  • 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.

    PubMed 21816498

  • 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.

    PubMed 17675039

  • 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.

    PubMed 28215584

  • 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.

    PubMed 12723990

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

    PubMed 19015764

  • 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.

    PubMed 20026580

  • 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.

    PubMed 18320165

  • 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.

    PubMed 19880785

  • 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.

    PubMed 30606158

  • 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.

    PubMed 28161369

Questions about this trial

What is this clinical trial studying?

A study testing oral glucose loading test in people with Diabetes, Gestational and Menstrual Cycle Abnormal, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational diabetes mellitus risk faktors (time frame: From the 24th week of pregnancy to the delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04251559, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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