Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus

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 .

Study Overview

• Status: Enrolling by invitation
• Conditions: Type1 Diabetes Mellitus; Menstrual Irregularities; Glucagon-Like Peptide-1 Receptor Agonists; Female Reproductive Health
• Intervention / Treatment: Drug: Dulaglutide

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11517
      • Ain Shams University
    • Cairo, Cairo Governorate, Egypt, 00202
      • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; 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: this group will only receive conventional insulin therapy.
Active Comparator: dulaglutide GROUP; 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.	Drug: Dulaglutide; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Self-Reported Menstrual Irregularities	Number and percentage of participants reporting menstrual irregularities (including oligomenorrhea, amenorrhea, or irregular menstrual cycle length) based on participant self-report.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Self-Reported Menstrual Irregularities	Change from baseline in the number and percentage of participants reporting menstrual irregularities following 3 months of treatment	Baseline to 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Self-Reported Menstrual Cycle Length (days)	Change from baseline in average menstrual cycle length as reported by participants	Baseline to 3 months
Number of Participants Reporting Regular Menstrual Cycles	Self-reported menstrual cycle length between 21 and 35 days	3 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Randa m. Matter, MD, Faculty of Medicine, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 24, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Adolescent Health; Female Reproductive Health
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; dulaglutide
• Other Study ID Numbers: FMASU MD142/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared outside the primary research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No