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Menses&Change in Diabetic Girl

Menstrual Cycle Changes in Adolescent Girls With Diabetes

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07194291
Enrollment
110
Registered
2025-09-26
Start date
2025-10-01
Completion date
2026-12-01
Last updated
2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Girls, Diabete Mellitus

Brief summary

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

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.

Interventions

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
10 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

1. Girls with diabetes diagnosed based on ADA guidelines Who reatched menarche of at least 1year duration \[14\]\] 2. Another comparable number of age matched non\_diabetic girls will be included as controls. 3/Female adolescents aged 10-18 years

Exclusion criteria

1. Girls Known thyroid disease or other endocrine disorders affecting menstruation 2. Girls taking medications that may affect menstrual cycles like Use of hormonal therapy (e.g., oral contraceptive pills) within the last 6 months 3. Menstraul irregularitis prior to diagnosis of diabetes

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with menstrual irregularities12 months (from enrollment)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.

Secondary

MeasureTime frameDescription
Association of menstrual irregularities with HbA1c and BMI12 months (from enrollment)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).

Contacts

Primary ContactZeinab megahed Mohamed, Principal Investigator
Zeniab.17289801@med.aun.edu.eg+20 10 07907104

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026