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

NCT07319286 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: FMASU MD142/2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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 .

Conditions

Menstrual Irregularities; Type1 Diabetes Mellitus; Glucagon-Like Peptide-1 Receptor Agonists; Female Reproductive Health

Keywords

Adolescent Health; Female Reproductive Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frequency of Self-Reported Menstrual Irregularities

  Baseline to 3 months

Other Outcomes (2)

• Change From Baseline in Self-Reported Menstrual Cycle Length (days)

  Baseline to 3 months

• Number of Participants Reporting Regular Menstrual Cycles

  3 months

Study Arms (2)

control

NO INTERVENTION

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.

dulaglutide GROUP

ACTIVE COMPARATOR

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

Interventions

Dulaglutide 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.

dulaglutide GROUP

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain shams university

Cairo, Cairo Governorate, 00202, Egypt

Location

Ain shams university

Cairo, Cairo Governorate, 11517, Egypt

Location

Related Publications (1)

• Almohareb SN, Alfayez OM, Aljuaid SS, Alshahrani WA, Bakhsh G, Alshammari MK, Al Yami MS, Alshaya OA, Alomran AS, Korayem GB, Almohammed OA. Effectiveness and Safety of GLP-1 Receptor Agonists in Patients with Type 1 Diabetes. J Clin Med. 2024 Oct 30;13(21):6532. doi: 10.3390/jcm13216532.

  PMID: 39518671 RESULT

MeSH Terms

Conditions

Menstruation Disturbances

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Randa m. Matter, MD

  Faculty of Medicine, Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 6, 2026
• Study Start: August 4, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)