Follow up of female sexual function
OtherWe follow up menstrual changes in diabetic adolescent girls to improve the outcome
NCT Number: NCT07194291
To assess menstraul cycle changes in adolescent girls with diabetes and to find out the various risk factors
Trial opening soon.
Get Notified10 year–20 year
Female
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
3/Female adolescents aged 10-18 years
Exclusion criteria
We follow up menstrual changes in diabetic adolescent girls to improve the outcome
Time frame: 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.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Menstrual Cycle Changes in Adolescent Girls With Diabetes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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