Menses&Change in Diabetic Girl

Not yet recruiting

• Conditions: Adolescent Girls; Diabete Mellitus

• Registration Number: NCT07194291
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-03
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Study Start: 2025-10-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with menstrual irregularities	12 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 Outcome Measures

Name	Time	Method
Association of menstrual irregularities with HbA1c and BMI	12 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).