Female Reproductive Health, Glucagon-Like Peptide-1 Receptor Agonists, Menstrual Irregularities, Type1 Diabetes Mellitus
Conditions
Keywords
Adolescent Health, Female Reproductive Health
Brief summary
The aim of this study is to measure the frequency of menstrual irregularities among adolescent females with Type 1 diabetes mellitus and to assess the therapeutic effect of glucagon-like peptide-1 receptor agonist on menstrual irregularities in adolescent females with Type 1 diabetes mellitus .
Detailed description
All studied patients with T1DM with poor glycemic control will be screened for menstrual irregularities based upon detailed history Taking, those who were found to have menstrual irregularities will be subdivided into 2 groups: * Group 1: will receive additional dulaglutide at a dose escalating from o.75 to 1.5 mg /week for 12 weeks to the conventional insulin therapy. * Group 2: will only receive conventional insulin therapy. Dulaglutide is an FDA-approved drug in the U.S.; however, this study is conducted entirely outside the United States and is not under an FDA IND.
Interventions
DRUGDulaglutide
All studied patients with T1DM with poor glycemic control will be screened for menstrual irregularities based upon detailed history Taking, those who were found to have menstrual irregularities will be subdivided into 2 groups: * Group 1: will receive additional dulaglutide at a dose escalating from o.75 to 1.5 mg /week for 12 weeks to the conventional insulin therapy. * Group 2: will only receive conventional insulin therapy.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All studied patients with T1DM with poor glycemic control will be screened for menstrual irregularities based upon detailed history Taking, those who were found to have menstrual irregularities will be subdivided into 2 groups: * Group 1: will receive additional dulaglutide at a dose escalating from o.75 to 1.5 mg /week for 12 weeks to the conventional insulin therapy. * Group 2: will only receive conventional insulin therapy.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Type 1 Diabetes Mellitus according to ISPAD criteria * Use of continuous glucose monitoring (CGM) * Receiving regular insulin therapy * Regular follow-up at a diabetes clinic * Female participants aged 12 to 18 years * At least 2 years post-menarche * Poor glycemic control, defined as HbA1c ≥ 7%
Exclusion criteria
* Presence of medical conditions known to cause menstrual irregularities, including:(Connective tissue disorders, Autoimmune diseases, Clinical thyroid dysfunction, Neurological diseases). * History of severe hypoglycemia within the past 12 months * Other causes of abnormal uterine bleeding, including:(Structural causes (e.g., leiomyoma, endometrial polyp), Coagulation disorders, Ovulatory disorders (e.g., hyperprolactinemia, hyperandrogenism), Iatrogenic causes (e.g., steroid therapy, oral contraceptive use) * Family history of medullary thyroid carcinoma or multiple endocrine neoplasia History of pancreatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Self-Reported Menstrual Irregularities | Baseline | Number and percentage of participants reporting menstrual irregularities (including oligomenorrhea, amenorrhea, or irregular menstrual cycle length) based on participant self-report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Self-Reported Menstrual Irregularities | Baseline to 3 months | Change from baseline in the number and percentage of participants reporting menstrual irregularities following 3 months of treatment |
Countries
Egypt
Contacts
STUDY_DIRECTORRanda m. Matter, MD
Faculty of Medicine, Ain Shams University
Outcome results
None listed