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Adolescent GirlsNCT07194291

Menses&Change in Diabetic Girl

An observational study of Adolescent Girls and Diabete Mellitus, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To assess menstraul cycle changes in adolescent girls with diabetes and to find out the various risk factors Read more about this study

Who is it for?
Ages 10 to 20 years, women only
Conditions the study is for
Adolescent Girls, Diabete Mellitus
What is being tested?
Follow up of female sexual function
How many people
110 participants
Where
No sites listed yet
Study dates
1 Oct 2025to 1 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 10 to 20 years
  • Women only
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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.
  • 3/Female adolescents aged 10-18 years

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zeinab megahed Mohamed, Principal Investigator contact

+20 10 07907104

Zeniab.17289801@med.aun.edu.eg

About this study

Official title: Menstrual Cycle Changes in Adolescent Girls With Diabetes

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

Read the detailed description

Type 1 diabetes mellitus (T1DM) is the result of autoimmunity mediated destruction of pancreatic beta cells, ultimately causing insulin deficiency and, consequently, hyperglycemia .

Typically the diagnosis of T1DM is made in childhood or adolescence,but about 40% of affected individuals are diagnosed in adulthood.

Hyperglycemia-related complications can contribute to impairment of endocrine axes, such as the hypothalamic pituitary gonadal (HPG) axis .

Historically, before the introduction of insulin replacement therapy, prepubertal girls wh developed T1DM rarely showed normal sexual development, exhibiting primary amenorrhea .

Although the introduction of insulin drastically changed the natural history of T1DM, allowing restoration of the HPG physiology, menarche delay remained as a typical sign in girls with T1DM .

In addition, women with T1DM report a higher incidence of menstrual irregularities >30%

compared with control subjects without diabetes .

Accordingly, signs and symptoms of androgen excess, such as acne and hirsutism, are more frequent in women with T1DM than in their age-matched counterparts

These interconnected abnormalities contribute to the reduced fertility observed in women with T1DM, as characterized by fewer pregnancies and live births and earlier menopause compared with women without diabetes.

Being tested
Follow up of female sexual function
Medical subject headings
Diabetes Mellitus

What participants receive

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

  • Follow up of female sexual functionOther

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

What is being measured

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

  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.

    Measured: 12 months (from enrollment)

Secondary outcomes (1)

  1. Association of menstrual irregularities with HbA1c and BMI

    HbA1c levels and body mass index (BMI) will be recorded at baseline and at 12 months. Data will be analyzed to assess correlations between menstrual irregularities and glycemic control (HbA1c, %) and nutritional status (BMI, kg/m²).

    Measured: 12 months (from enrollment)

Timeline

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

  1. First posted26 Sep 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07194291
Sponsor's protocol ID
Menses&Change in diabetic Girl
Status last verified
Sep 2025
First submitted
3 Sep 2025
Last updated
26 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25681196

  • 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.

    PubMed 38993726

  • 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.

    PubMed 21170514

  • 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.

    PubMed 22127492

  • 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.

    PubMed 21995767

  • 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.

    PubMed 12663566

  • 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.

    PubMed 1639955

  • 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.

    PubMed 7016641

  • 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.

    PubMed 648900

  • 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.

    PubMed 8556032

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

    PubMed 13147722

  • 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.

    PubMed 16239312

  • 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.

    PubMed 33298413

  • 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.

    PubMed 34755679

  • 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.

    PubMed 29191919

Questions about this trial

What is this clinical trial studying?

An observational study of Adolescent Girls and Diabete Mellitus, run by Assiut University.

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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Zeinab megahed Mohamed, Principal Investigator (+20 10 07907104, Zeniab.17289801@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with menstrual irregularities (time frame: 12 months (from enrollment)). 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 NCT07194291, which also lists 15 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 26 Sep 2025.

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