Status
Enrolling by invitation
Phase
Phase 1 / Phase 2
Enrollment
50
Locations
2
Results
Not posted
Publications
1
Study 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 .
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
DRUG
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.
Timeline
First posted
Jan 6, 2026
Study start
Aug 4, 2025
Primary completion
Dec 2026
Study completion
Mar 2027
Results posted
Not reported
Registry updated
Jun 5, 2026
Outcomes
Frequency of Self-Reported Menstrual Irregularities
Time frame · Baseline
Number and percentage of participants reporting menstrual irregularities (including oligomenorrhea, amenorrhea, or irregular menstrual cycle length) based on participant self-report.
Frequency of Self-Reported Menstrual Irregularities
Time frame · Baseline to 3 months
Change from baseline in the number and percentage of participants reporting menstrual irregularities following 3 months of treatment
Eligibility
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
Study locations
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Ain shams university
Cairo, Cairo Governorate, Egypt
Ain shams university
Cairo, Cairo Governorate, Egypt
Publications
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