Menses&Change in Diabetic Girl
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Follow up of female sexual function.
- Who it may be relevant to
- Registry conditions: Adolescent Girls, Diabete Mellitus. Basic parameters: 10 years — 20 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Menstrual Cycle Changes in Adolescent Girls With Diabetes
Overview
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
- Other Follow up of female sexual function
We follow up menstrual changes in diabetic adolescent girls to improve the outcome
Primary outcome measures
- Number of participants with menstrual irregularities [Time frame: 12 months (from enrollment)]
Secondary outcome measures (1)
- Association of menstrual irregularities with HbA1c and BMI [Time frame: 12 months (from enrollment)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 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. PMID 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. PMID 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 PMID 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. PMID 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. PMID 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. PMID 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. PMID 7016641
Identifiers
NCT: NCT07194291 · Menses&Change in diabetic Girl