NCT07194291

Brief Summary

To assess menstraul cycle changes in adolescent girls with diabetes and to find out the various risk factors

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

September 3, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 3, 2025

Last Update Submit

September 18, 2025

Conditions

Adolescent GirlsDiabete Mellitus

Outcome Measures

Primary Outcomes (1)

  • Number of participants with menstrual irregularities

    Menstrual cycle characteristics (cycle length, frequency, and regularity) will be documented using a structured menstrual diary and standardized questionnaire. Menstrual irregularity will be defined as the presence of oligomenorrhea (cycle length \> 35 days), amenorrhea (≥ 3 months without menstruation), or polymenorrhea (cycle length \< 21 days). Data will be summarized as the number and percentage of participants meeting any of these criteria.

    12 months (from enrollment)

Secondary Outcomes (1)

  • Association of menstrual irregularities with HbA1c and BMI

    12 months (from enrollment)

Interventions

Follow up of female sexual functionOTHER

We follow up menstrual changes in diabetic adolescent girls to improve the outcome

Eligibility Criteria

Age10 Years - 20 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Adolescent girls with diabetes are at higher risk of menstrual cycle irregularities due to metabolic, hormonal, and nutritional factors. Early recognition of these changes is essential to improve reproductive health and overall quality of life.

You may qualify if:

  • Girls with diabetes diagnosed based on ADA guidelines Who reatched menarche of at least 1year duration \[14\]\]
  • Another comparable number of age matched non\_diabetic girls will be included as controls.
  • /Female adolescents aged 10-18 years

You may not qualify if:

  • Girls Known thyroid disease or other endocrine disorders affecting menstruation
  • Girls taking medications that may affect menstrual cycles like Use of hormonal therapy (e.g., oral contraceptive pills) within the last 6 months
  • Menstraul irregularitis prior to diagnosis of diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • Ghitha N, Vathania N, Wiyono L, Pulungan A. Delayed menarche in children and adolescents with type 1 diabetes mellitus: a systematic review and meta-analysis. Clin Pediatr Endocrinol. 2024;33(3):104-112. doi: 10.1297/cpe.2023-0058. Epub 2024 Apr 19.

    PMID: 38993726BACKGROUND

  • Whitworth KW, Baird DD, Stene LC, Skjaerven R, Longnecker MP. Fecundability among women with type 1 and type 2 diabetes in the Norwegian Mother and Child Cohort Study. Diabetologia. 2011 Mar;54(3):516-22. doi: 10.1007/s00125-010-2003-6. Epub 2010 Dec 19.

    PMID: 21170514BACKGROUND

  • Gu YH, Yokoyama K, Mizuta K, Tsuchioka T, Kudo T, Sasaki H, Nio M, Tang J, Ohkubo T, Matsui A. Stool color card screening for early detection of biliary atresia and long-term native liver survival: a 19-year cohort study in Japan. J Pediatr. 2015 Apr;166(4):897-902.e1. doi: 10.1016/j.jpeds.2014.12.063. Epub 2015 Feb 11.

    PMID: 25681196BACKGROUND

  • Samara-Boustani D, Colmenares A, Elie C, Dabbas M, Beltrand J, Caron V, Ricour C, Jacquin P, Tubiana-Rufi N, Levy-Marchal C, Delcroix C, Martin D, Benadjaoud L, Jacqz Aigrain E, Trivin C, Laborde K, Thibaud E, Robert JJ, Polak M. High prevalence of hirsutism and menstrual disorders in obese adolescent girls and adolescent girls with type 1 diabetes mellitus despite different hormonal profiles. Eur J Endocrinol. 2012 Feb;166(2):307-16. doi: 10.1530/EJE-11-0670. Epub 2011 Nov 29.

    PMID: 22127492BACKGROUND

  • Codner E, Soto N, Merino PM. Contraception, and pregnancy in adolescents with type 1 diabetes: a review. Pediatr Diabetes. 2012 Feb;13(1):108-23. doi: 10.1111/j.1399-5448.2011.00825.x. Epub 2011 Oct 13.

    PMID: 21995767BACKGROUND

  • Strotmeyer ES, Steenkiste AR, Foley TP Jr, Berga SL, Dorman JS. Menstrual cycle differences between women with type 1 diabetes and women without diabetes. Diabetes Care. 2003 Apr;26(4):1016-21. doi: 10.2337/diacare.26.4.1016.

    PMID: 12663566BACKGROUND

  • Kjaer K, Hagen C, Sando SH, Eshoj O. Epidemiology of menarche and menstrual disturbances in an unselected group of women with insulin-dependent diabetes mellitus compared to controls. J Clin Endocrinol Metab. 1992 Aug;75(2):524-9. doi: 10.1210/jcem.75.2.1639955.

    PMID: 1639955BACKGROUND

  • Green A, Hauge M, Holm NV, Rasch LL. Epidemiological studies of diabetes mellitus in Denmark. II. A prevalence study based on insulin prescriptions. Diabetologia. 1981 Apr;20(4):468-70. doi: 10.1007/BF00253409.

    PMID: 7016641BACKGROUND

  • Trzeciak B. [Effect of diabetes mellitus on the incidence of abnormal genital bleedings in women]. Ginekol Pol. 1978 Feb;49(2):119-23. No abstract available. Polish.

    PMID: 648900BACKGROUND

  • Yeshaya A, Orvieto R, Dicker D, Karp M, Ben-Rafael Z. Menstrual characteristics of women suffering from insulin-dependent diabetes mellitus. Int J Fertil Menopausal Stud. 1995 Sep-Oct;40(5):269-73.

    PMID: 8556032BACKGROUND

  • BERGQVIST N. The gonadal function in female diabetics. Acta Endocrinol Suppl (Copenh). 1954;19:1-20. No abstract available.

    PMID: 13147722BACKGROUND

  • Arrais RF, Dib SA. The hypothalamus-pituitary-ovary axis and type 1 diabetes mellitus: a mini review. Hum Reprod. 2006 Feb;21(2):327-37. doi: 10.1093/humrep/dei353. Epub 2005 Oct 20.

    PMID: 16239312BACKGROUND

  • American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S15-S33. doi: 10.2337/dc21-S002.

    PMID: 33298413BACKGROUND

  • Richardson SJ, Pugliese A. 100 YEARS OF INSULIN: Pancreas pathology in type 1 diabetes: an evolving story. J Endocrinol. 2021 Dec 9;252(2):R41-R57. doi: 10.1530/JOE-21-0358.

    PMID: 34755679BACKGROUND

  • Paschou SA, Papadopoulou-Marketou N, Chrousos GP, Kanaka-Gantenbein C. On type 1 diabetes mellitus pathogenesis. Endocr Connect. 2018 Jan;7(1):R38-R46. doi: 10.1530/EC-17-0347. Epub 2017 Nov 30.

    PMID: 29191919BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Zeinab megahed Mohamed, Principal Investigator

CONTACT

+20 10 07907104Zeniab.17289801@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 26, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 26, 2025

Record last verified: 2025-09